Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-03-05 @ 1:15 PM
Study NCT ID:
NCT03866902
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2019-02-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Healthy Mothers-Healthy Children Nutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009752', 'term': 'Nutritional Status'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hsantos@miami.edu', 'phone': '3052845812', 'title': 'Hudson Santos', 'organization': 'University of Miami'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '15 months', 'description': 'Both the mother and child were monitored for 4 years for the duration over which adverse events were monitored/assessed', 'eventGroups': [{'id': 'EG000', 'title': 'Nutrition and Physical Activity Intervention-Mother', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.', 'otherNumAtRisk': 144, 'deathsNumAtRisk': 144, 'otherNumAffected': 0, 'seriousNumAtRisk': 144, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'English for Second Language Intervention-Mother', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.', 'otherNumAtRisk': 143, 'deathsNumAtRisk': 143, 'otherNumAffected': 0, 'seriousNumAtRisk': 143, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Nutrition and Physical Activity Intervention-Child', 'description': 'Classes for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.', 'otherNumAtRisk': 144, 'deathsNumAtRisk': 144, 'otherNumAffected': 0, 'seriousNumAtRisk': 144, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'English for Second Language Intervention-Child', 'description': 'Children in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.', 'otherNumAtRisk': 143, 'deathsNumAtRisk': 143, 'otherNumAffected': 0, 'seriousNumAtRisk': 143, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Change in Mother's Height From Baseline (Time 1) to Time 2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.00977', 'spread': '0.485', 'groupId': 'OG000'}, {'value': '0.000505', 'spread': '0.00503', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Height in centimeters', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Change in Mother's Height From Baseline (Time 1) to Time 3", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.00116', 'spread': '0.0108', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Height in centimeters', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Change in Children's Height From Baseline (Time 1) to Time 2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.62', 'spread': '3.38', 'groupId': 'OG000'}, {'value': '7.86', 'spread': '3.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Height in centimeters', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Change in Children's Height From Baseline (Time 1) to Time 3", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'spread': '3.39', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '3.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Height in centimeters', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Change in Mother's Weight From Baseline (Time 1) to Time 2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0776', 'spread': '3.68', 'groupId': 'OG000'}, {'value': '-0.431', 'spread': '4.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Weight in kilograms', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Change in Mother's Weight From Baseline (Time 1) to Time 3", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.488', 'spread': '4.25', 'groupId': 'OG000'}, {'value': '0.435', 'spread': '4.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Weight in kilograms', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Change in Children's Weight From Baseline (Time 1) to Time 2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.36', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '3.11', 'spread': '2.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Weight in kilograms', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Change in Children's Weight From Baseline (Time 1) to Time 3", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.81', 'spread': '3.39', 'groupId': 'OG000'}, {'value': '4.63', 'spread': '3.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Weight in kilograms', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Change in Mother's BMI From Baseline (Time 1) to Time 2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0437', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '-0.170', 'spread': '1.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Calculation of BMI in Mothers in kilograms divided by meters squared', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Change in Mother's BMI From Baseline (Time 1) to Time 3", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.194', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '0.195', 'spread': '1.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Calculation of BMI in Mothers in kilograms divided by meters squared', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Change in Children's BMI Percentile From Baseline (Time 1) to Time 2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.21', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '-7.69', 'spread': '18.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Calculation of BMI measured in percentage in Children. Calculated by the percentage of the mean BMI.', 'unitOfMeasure': "percentage of children's BMI", 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Change in Children's BMI Percentile From Baseline (Time 1) to Time 3", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.69', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '-7.21', 'spread': '20.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Calculation of BMI Percentile in Children. Calculated by the percentage of the mean BMI.', 'unitOfMeasure': "percentage of children's BMI", 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Change in Mother's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.172', 'spread': '5.42', 'groupId': 'OG000'}, {'value': '0.661', 'spread': '4.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Waist Circumference in centimeters', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Change in Mother's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.769', 'spread': '6.77', 'groupId': 'OG000'}, {'value': '0.399', 'spread': '6.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Waist Circumference in centimeters', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Change in Children's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.38', 'spread': '4.74', 'groupId': 'OG000'}, {'value': '4.77', 'spread': '4.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Waist circumference in centimeters', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Change in Children's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.00', 'spread': '4.61', 'groupId': 'OG000'}, {'value': '5.71', 'spread': '5.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Waist circumference in Centimeters', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Change in Mother's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.421', 'spread': '6.85', 'groupId': 'OG000'}, {'value': '-0.848', 'spread': '7.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Triceps skinfolds in Millimeters', 'unitOfMeasure': 'Millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Change in Mother's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 3", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.77', 'spread': '6.95', 'groupId': 'OG000'}, {'value': '-0.854', 'spread': '7.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Triceps skinfolds in millimeters', 'unitOfMeasure': 'Millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Change in Children's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.734', 'spread': '4.51', 'groupId': 'OG000'}, {'value': '0.920', 'spread': '5.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Triceps skinfolds in millimeters', 'unitOfMeasure': 'Millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Change in Children's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 3", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.02', 'spread': '4.60', 'groupId': 'OG000'}, {'value': '1.35', 'spread': '4.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Triceps skinfolds in millimeters', 'unitOfMeasure': 'Millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Change in Mother's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.697', 'spread': '5.98', 'groupId': 'OG000'}, {'value': '0.558', 'spread': '6.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Subscapular skinfolds in millimeters', 'unitOfMeasure': 'Millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Change in Mother's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'spread': '6.14', 'groupId': 'OG000'}, {'value': '0.737', 'spread': '7.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Subscapular skinfolds in millimeters', 'unitOfMeasure': 'Millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Change in Children's Adiposity (Subscapular Skinfolds) From Baseline (Time 1) to Time 2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.13', 'spread': '3.40', 'groupId': 'OG000'}, {'value': '0.984', 'spread': '3.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Subscapular skinfolds in millimeters', 'unitOfMeasure': 'Millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Change in Children's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3", 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'OG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.06', 'spread': '3.79', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '4.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Subscapular skinfolds in millimeters', 'unitOfMeasure': 'Millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Health Behaviors (Adult Health Behavior Questionnaire) in Mothers Baseline (Time 1) to Time 2', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'There are 23 questions with a range of answers for each question. Each question is scored individually as a predetermined healthy or unhealthy choice.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Health Behaviors (Adult Health Behavior Questionnaire) in Mothers Baseline (Time 1) to Time 3', 'timeFrame': 'Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)', 'description': 'There are 23 questions with a range of answers for each question. Each question is scored individually as a predetermined healthy or unhealthy choice.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Health Behaviors (Health Promoting Lifestyle Profile II) in Mothers Baseline (Time 1) to Time 2', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'There are 34 questions and the answer choices are never, sometime, often or routinely. Never is scored a 0, sometimes is scored a 1, often is scored a 2 and routine is scored a 3. The 34 questions are summed to provide a total score. A higher score reflects healthier behaviors and a lower score reflects unhealthier behaviors.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Health Behaviors (Health Promoting Lifestyle Profile II) in Mothers From Baseline (Time 1) to Time 3', 'timeFrame': 'Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)', 'description': 'There are 34 questions and the answer choices are never, sometime, often or routinely. Never is scored a 0, sometimes is scored a 1, often is scored a 2 and routine is scored a 3. The 34 questions are summed to provide a total score. A higher score reflects healthier behaviors and a lower score reflects unhealthier behaviors.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Health Behaviors (24 Hour Food Recall) for 3 Days in Mothers From Baseline (Time 1) to Time 2', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Phone Interview with the Mother on a Monday, Tuesday and Wednesday. The research assistant will ask the mother what she ate at breakfast, lunch, dinner and snacks and approximate amounts. This information will be entered into nutritionistpro a software program. Then total calories, protein, carbohydrate and fat can be calculated for each day.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Health Behaviors (24 Hour Food Recall) for 3 Days in Mothers From Baseline (Time 1) to Time 3', 'timeFrame': 'Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)', 'description': 'Phone Interview with the Mother on a Monday, Tuesday and Wednesday. The research assistant will ask the mother what she ate at breakfast, lunch, dinner and snacks and approximate amounts. This information will be entered into nutritionistpro a software program. Then total calories, protein, carbohydrate and fat can be calculated for each day.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Health Behaviors (24 Hour Food Recall) for 3 Days in Children From Baseline (Time 1) to Time 2', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Phone Interview with the Mother on a Monday, Tuesday and Wednesday. The research assistant will ask the mother what her child ate at breakfast, lunch, dinner and snacks and approximate amounts. This information will be entered into nutritionistpro a software program. Then total calories, protein, carbohydrate and fat can be calculated for each day.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Health Behaviors (24 Hour Food Recall) for 3 Days in Children From Baseline (Time 1) to Time 3', 'timeFrame': 'Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)', 'description': 'Phone Interview with the Mother on a Monday, Tuesday and Wednesday. The research assistant will ask the mother what her child ate at breakfast, lunch, dinner and snacks and approximate amounts. This information will be entered into nutritionistpro a software program. Then total calories, protein, carbohydrate and fat can be calculated for each day.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Mothers From Baseline (Time 1) to Time 2', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'The Mother will wear an accelerometer for 7 days total. This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Mothers From Baseline (Time 1) to Time 3', 'timeFrame': 'Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)', 'description': 'The Mother will wear an accelerometer for 7 days total. This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Children From Baseline (Time 1) to Time 2', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'The Child will wear an accelerometer for 7 days total. This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Children From Baseline (Time 1) to Time 3', 'timeFrame': 'Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)', 'description': 'The Child will wear an accelerometer for 7 days total. This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Eating Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 2', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'This is a 25 question questionnaire asking how much difficulty the Mother has with controlling her eating in social situations and everyday. The range of scores go from 1 to 7 with 1 being no difficulty controlling eating to 4 moderate difficulty controlling eating to 7 the most difficulty controlling eating. The 25 questions are added to produce a total score. A lower score equals less difficulty controlling eating and a higher score equals more difficulty controlling eating.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Eating Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 3', 'timeFrame': 'Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)', 'description': 'This is a 25 question questionnaire asking how much difficulty the Mother has with controlling her eating in social situations and everyday. The range of scores go from 1 to 7 with 1 being no difficulty controlling eating to 4 moderate difficulty controlling eating to 7 the most difficulty controlling eating. The 25 questions are added to produce a total score. A lower score equals less difficulty controlling eating and a higher score equals more difficulty controlling eating.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Exercise Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 2', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'This is a 18 question questionnaire asking how much difficulty the Mother has with exercise. The range of scores go from 1 to 10 with 1 being she can not do it at all and 6 that she can moderately do exercise and a 10 that she is certain she can do it. The numbers are summed for a total score. A lower number indicates that the mother has a lot of difficulty exercising and a higher number means that the mother is more certain she can exercise.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Exercise Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 3', 'timeFrame': 'Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)', 'description': 'This is a 18 question questionnaire asking how much difficulty the Mother has with exercise. The range of scores go from 1 to 10 with 1 being she can not do it at all and 6 that she can moderately do exercise and a 10 that she is certain she can do it. The numbers are summed for a total score. A lower number indicates that the mother has a lot of difficulty exercising and a higher number means that the mother is more certain she can exercise.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'FG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '288'}, {'groupId': 'FG001', 'numSubjects': '286'}]}, {'type': 'Mother', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '143'}]}, {'type': 'Child', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '143'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '180'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}, {'groupId': 'FG001', 'numSubjects': '106'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '24'}]}]}], 'preAssignmentDetails': 'Dyad study design. Only one consent was signed by mother to agree to both mother and child to participant in the study; therefore, a total of 578 were enrolled in the study. 4 signed the consent but were not randomized into the groups for this study and did not participate in the intervention because of a lack of desire to participate just prior to the intervention starting; therefore, were not enrolled in the arms. Mother/child dyads that went into the arms/groups Total= 574.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'BG000'}, {'value': '286', 'groupId': 'BG001'}, {'value': '574', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nNutrition and Physical Activity Intervention: Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.'}, {'id': 'BG001', 'title': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.\n\nEnglish for Second Language Intervention: Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Mother', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34.9', 'spread': '6.63', 'groupId': 'BG000'}, {'value': '34.6', 'spread': '6.60', 'groupId': 'BG001'}, {'value': '34.8', 'spread': '6.60', 'groupId': 'BG002'}]}]}, {'title': 'Child', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.33', 'spread': '0.988', 'groupId': 'BG000'}, {'value': '4.42', 'spread': '0.905', 'groupId': 'BG001'}, {'value': '4.38', 'spread': '0.947', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': "One of the mother's data for age was not collected."}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Mother', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Child', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': "One of the child's data for the sex was not collected."}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only data for the mother was collected.'}], 'populationDescription': 'This is a dyad study. Data was collected for both mother and child for the gender and age category. Ethnicity was only collected for mother.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-19', 'size': 914225, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-12T16:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The statistician has created a randomization table in RedCap. After enrollment and baseline assessment, dyads will be randomized to either the intervention or control group using a computer-generated randomization table, stratifying by BMI group, overweight (25 - 29.9 kg/m²) and obese (\\>30 kg/m²), and utilizing blocking to help ensure balance between the groups. Mothers will be informed of their group assignment by telephone.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two group randomized controlled repeated measures study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 578}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-20', 'studyFirstSubmitDate': '2019-02-24', 'resultsFirstSubmitDate': '2024-04-11', 'studyFirstSubmitQcDate': '2019-03-05', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-20', 'studyFirstPostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in Mother's Height From Baseline (Time 1) to Time 2", 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Height in centimeters'}, {'measure': "Change in Mother's Height From Baseline (Time 1) to Time 3", 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Height in centimeters'}, {'measure': "Change in Children's Height From Baseline (Time 1) to Time 2", 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Height in centimeters'}, {'measure': "Change in Children's Height From Baseline (Time 1) to Time 3", 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Height in centimeters'}, {'measure': "Change in Mother's Weight From Baseline (Time 1) to Time 2", 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Weight in kilograms'}, {'measure': "Change in Mother's Weight From Baseline (Time 1) to Time 3", 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Weight in kilograms'}, {'measure': "Change in Children's Weight From Baseline (Time 1) to Time 2", 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Weight in kilograms'}, {'measure': "Change in Children's Weight From Baseline (Time 1) to Time 3", 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Weight in kilograms'}, {'measure': "Change in Mother's BMI From Baseline (Time 1) to Time 2", 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Calculation of BMI in Mothers in kilograms divided by meters squared'}, {'measure': "Change in Mother's BMI From Baseline (Time 1) to Time 3", 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Calculation of BMI in Mothers in kilograms divided by meters squared'}, {'measure': "Change in Children's BMI Percentile From Baseline (Time 1) to Time 2", 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Calculation of BMI measured in percentage in Children. Calculated by the percentage of the mean BMI.'}, {'measure': "Change in Children's BMI Percentile From Baseline (Time 1) to Time 3", 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Calculation of BMI Percentile in Children. Calculated by the percentage of the mean BMI.'}, {'measure': "Change in Mother's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2", 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Waist Circumference in centimeters'}, {'measure': "Change in Mother's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3", 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Waist Circumference in centimeters'}, {'measure': "Change in Children's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2", 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Waist circumference in centimeters'}, {'measure': "Change in Children's Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3", 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Waist circumference in Centimeters'}, {'measure': "Change in Mother's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 2", 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Triceps skinfolds in Millimeters'}, {'measure': "Change in Mother's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 3", 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Triceps skinfolds in millimeters'}, {'measure': "Change in Children's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 2", 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Triceps skinfolds in millimeters'}, {'measure': "Change in Children's Adiposity (Triceps Skinfold) From Baseline (Time 1) to Time 3", 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Triceps skinfolds in millimeters'}, {'measure': "Change in Mother's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 2", 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Subscapular skinfolds in millimeters'}, {'measure': "Change in Mother's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3", 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Subscapular skinfolds in millimeters'}, {'measure': "Change in Children's Adiposity (Subscapular Skinfolds) From Baseline (Time 1) to Time 2", 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Subscapular skinfolds in millimeters'}, {'measure': "Change in Children's Adiposity (Subscapular Skinfolds) Baseline (Time 1) to Time 3", 'timeFrame': 'Baseline (Time 1), Time 3 (approximately 15 months)', 'description': 'Subscapular skinfolds in millimeters'}], 'secondaryOutcomes': [{'measure': 'Change in Health Behaviors (Adult Health Behavior Questionnaire) in Mothers Baseline (Time 1) to Time 2', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'There are 23 questions with a range of answers for each question. Each question is scored individually as a predetermined healthy or unhealthy choice.'}, {'measure': 'Change in Health Behaviors (Adult Health Behavior Questionnaire) in Mothers Baseline (Time 1) to Time 3', 'timeFrame': 'Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)', 'description': 'There are 23 questions with a range of answers for each question. Each question is scored individually as a predetermined healthy or unhealthy choice.'}, {'measure': 'Change in Health Behaviors (Health Promoting Lifestyle Profile II) in Mothers Baseline (Time 1) to Time 2', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'There are 34 questions and the answer choices are never, sometime, often or routinely. Never is scored a 0, sometimes is scored a 1, often is scored a 2 and routine is scored a 3. The 34 questions are summed to provide a total score. A higher score reflects healthier behaviors and a lower score reflects unhealthier behaviors.'}, {'measure': 'Change in Health Behaviors (Health Promoting Lifestyle Profile II) in Mothers From Baseline (Time 1) to Time 3', 'timeFrame': 'Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)', 'description': 'There are 34 questions and the answer choices are never, sometime, often or routinely. Never is scored a 0, sometimes is scored a 1, often is scored a 2 and routine is scored a 3. The 34 questions are summed to provide a total score. A higher score reflects healthier behaviors and a lower score reflects unhealthier behaviors.'}, {'measure': 'Change in Health Behaviors (24 Hour Food Recall) for 3 Days in Mothers From Baseline (Time 1) to Time 2', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Phone Interview with the Mother on a Monday, Tuesday and Wednesday. The research assistant will ask the mother what she ate at breakfast, lunch, dinner and snacks and approximate amounts. This information will be entered into nutritionistpro a software program. Then total calories, protein, carbohydrate and fat can be calculated for each day.'}, {'measure': 'Change in Health Behaviors (24 Hour Food Recall) for 3 Days in Mothers From Baseline (Time 1) to Time 3', 'timeFrame': 'Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)', 'description': 'Phone Interview with the Mother on a Monday, Tuesday and Wednesday. The research assistant will ask the mother what she ate at breakfast, lunch, dinner and snacks and approximate amounts. This information will be entered into nutritionistpro a software program. Then total calories, protein, carbohydrate and fat can be calculated for each day.'}, {'measure': 'Change in Health Behaviors (24 Hour Food Recall) for 3 Days in Children From Baseline (Time 1) to Time 2', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'Phone Interview with the Mother on a Monday, Tuesday and Wednesday. The research assistant will ask the mother what her child ate at breakfast, lunch, dinner and snacks and approximate amounts. This information will be entered into nutritionistpro a software program. Then total calories, protein, carbohydrate and fat can be calculated for each day.'}, {'measure': 'Change in Health Behaviors (24 Hour Food Recall) for 3 Days in Children From Baseline (Time 1) to Time 3', 'timeFrame': 'Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)', 'description': 'Phone Interview with the Mother on a Monday, Tuesday and Wednesday. The research assistant will ask the mother what her child ate at breakfast, lunch, dinner and snacks and approximate amounts. This information will be entered into nutritionistpro a software program. Then total calories, protein, carbohydrate and fat can be calculated for each day.'}, {'measure': 'Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Mothers From Baseline (Time 1) to Time 2', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'The Mother will wear an accelerometer for 7 days total. This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity.'}, {'measure': 'Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Mothers From Baseline (Time 1) to Time 3', 'timeFrame': 'Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)', 'description': 'The Mother will wear an accelerometer for 7 days total. This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity.'}, {'measure': 'Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Children From Baseline (Time 1) to Time 2', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'The Child will wear an accelerometer for 7 days total. This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity.'}, {'measure': 'Change in Health Behaviors (Accelerometer Measurement for 7 Days) in Children From Baseline (Time 1) to Time 3', 'timeFrame': 'Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)', 'description': 'The Child will wear an accelerometer for 7 days total. This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity.'}, {'measure': 'Change in Eating Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 2', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'This is a 25 question questionnaire asking how much difficulty the Mother has with controlling her eating in social situations and everyday. The range of scores go from 1 to 7 with 1 being no difficulty controlling eating to 4 moderate difficulty controlling eating to 7 the most difficulty controlling eating. The 25 questions are added to produce a total score. A lower score equals less difficulty controlling eating and a higher score equals more difficulty controlling eating.'}, {'measure': 'Change in Eating Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 3', 'timeFrame': 'Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)', 'description': 'This is a 25 question questionnaire asking how much difficulty the Mother has with controlling her eating in social situations and everyday. The range of scores go from 1 to 7 with 1 being no difficulty controlling eating to 4 moderate difficulty controlling eating to 7 the most difficulty controlling eating. The 25 questions are added to produce a total score. A lower score equals less difficulty controlling eating and a higher score equals more difficulty controlling eating.'}, {'measure': 'Change in Exercise Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 2', 'timeFrame': 'Baseline (Time 1), Time 2 (Intervention completion, approximately 9 months)', 'description': 'This is a 18 question questionnaire asking how much difficulty the Mother has with exercise. The range of scores go from 1 to 10 with 1 being she can not do it at all and 6 that she can moderately do exercise and a 10 that she is certain she can do it. The numbers are summed for a total score. A lower number indicates that the mother has a lot of difficulty exercising and a higher number means that the mother is more certain she can exercise.'}, {'measure': 'Change in Exercise Self-Efficacy Questionnaire in Mothers From Baseline (Time 1) to Time 3', 'timeFrame': 'Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 15 months)', 'description': 'This is a 18 question questionnaire asking how much difficulty the Mother has with exercise. The range of scores go from 1 to 10 with 1 being she can not do it at all and 6 that she can moderately do exercise and a 10 that she is certain she can do it. The numbers are summed for a total score. A lower number indicates that the mother has a lot of difficulty exercising and a higher number means that the mother is more certain she can exercise.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['overweight', 'obesity', 'adiposity', 'nutrition', 'physical activity', 'Hispanic'], 'conditions': ['Overweight and Obesity', 'Adiposity', 'Nutrient; Excess', 'Physical Activity']}, 'referencesModule': {'references': [{'pmid': '32153971', 'type': 'DERIVED', 'citation': 'Berry DC, Gonzales C, Montano NP, Perreira KM, Ammerman AS, Crandell J, Evenson KR, Faith MS, Waters H, Linares C, Comicronrtes YI, Perrin EM. Rationale, design, and methodology for the healthy mothers-healthy children study: a randomized controlled trial. BMC Nutr. 2019 Dec 16;5:58. doi: 10.1186/s40795-019-0322-7. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'Using a randomized two-group, repeated measures experimental design, the goal of the proposed study is to investigate the efficacy of a 12-week nutrition and exercise education, physical activity, coping skills training, and home-based physical activity intervention in Hispanic women and their 3-5 year old children and 6 months of continued monthly contact to help overweight and obese Hispanic mothers improve adiposity, weight, health behaviors, and self-efficacy and their 3-5 year old children improve their adiposity and weight gain trajectory and health behaviors.', 'detailedDescription': 'Hispanic women and children who become overweight or obese are at risk for developing prediabetes, type 2 diabetes, and cardiovascular disease later in life. To date, there have been no interdisciplinary interventions that have targeted Hispanic women and their 3-5 year old children to improve nutrition and physical activity behaviors to manage adiposity and weight in mothers and prevent excessive adiposity and weight gain trajectory in their children. Using a randomized two-group, repeated measures experimental design, the goal of the proposed study is to investigate the efficacy of a 12-week nutrition and exercise education, physical activity, coping skills training, and home-based physical activity intervention in Hispanic women and their 3-5 year old children and 6 months of continued monthly contact to help overweight and obese Hispanic mothers improve adiposity, weight, health behaviors (nutrition and physical activity), and self-efficacy and their 3-5 year old children improve their adiposity and weight gain trajectory and health behaviors (nutrition and physical activity). The investigators will partner with two federally qualified health departments in Durham and Chatham, North Carolina to enroll Hispanic women and their 3-5 year old children and the investigators will partner with community centers to deliver the intervention. A total of 294 Hispanic women with a BMI \\>25 kg/m² and 294 Hispanic 3-5 year old children with a BMI percentile \\> 25 will be enrolled over 4 years and randomized to the experimental or equal attention control group. Data will be collected at Time 1 (0 months \\[baseline\\]) to Time 2 (9 months \\[completion of the intervention\\]) and Time 1 to Time 3 (15 months \\[after 6 months with no contact from the study staff\\]). Data collected will include adiposity (primary outcomes: waist circumference, triceps and subscapular skinfolds) in mothers and children and weight (primary outcomes: body mass index \\[BMI\\] in mothers and BMI percentile in the children). Secondary outcomes will include health behaviors and self-efficacy in the mothers (Adult Health Behavior Questionnaire, Lifestyle Health Promoting Profile II, 3 day 24-Hour Food Recall, and 7 day Accelerometer, Eating Self-Efficacy Scale and Exercise Self-Efficacy Scale) and in the children (7 day Accelerometer and 3 day 24-Hour Food Recall). The investigators will also evaluate the cost of delivering the program for public health departments. Data analysis will use general linear mixed models to test the hypotheses. Decreasing overweight and obesity in Hispanic women and slowing adiposity and weight gain trajectory in young Hispanic children is urgently needed to decrease morbidity, mortality, and future health care costs. The knowledge to be gained from this study may provide a foundation for extending this intervention to other Hispanic mothers and children in other communities to assist mothers in managing their weight and preventing excessive adiposity and weight gain in their children. This approach is translatable, real-world, and could be replicated in other areas of the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria for mothers will be:\n\n* age 18 years or older\n* self-identification as Hispanic\n* limited English proficiency; little acculturation, as measured by the Short Acculturation Scale for Hispanics with a score from 1.00 to 2.99\n* ability to understand spoken Spanish\n* a BMI \\>25kg/m\\^2\n* residence with the child\n* consent to join the study and consent for their child to join the study.\n\nInclusion criteria for children will be:\n\n* age 3-5 years\n* ability to understand spoken Spanish\n* a BMI \\> 25th percentile for age and gender\n\nExclusion criteria for mothers will be:\n\n* heart murmur\n* congenital heart disease\n* family history of sudden death\n* difficulty exercising\n* psychological problems'}, 'identificationModule': {'nctId': 'NCT03866902', 'acronym': 'HMHC', 'briefTitle': 'Healthy Mothers-Healthy Children Nutrition', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Healthy Mothers-Healthy Children: An Intervention With Hispanic Mothers and Their Young Children', 'orgStudyIdInfo': {'id': '20220623'}, 'secondaryIdInfos': [{'id': '1R01NR017199-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01NR017199-01', 'type': 'NIH'}, {'id': '17-0979', 'type': 'OTHER', 'domain': 'UNC Chapel Hill'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutrition and Physical Activity Intervention', 'description': 'Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months.\n\nClasses for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months.', 'interventionNames': ['Behavioral: Nutrition and Physical Activity Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'English for Second Language Intervention', 'description': 'Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months.\n\nChildren in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months.', 'interventionNames': ['Other: English for Second Language Intervention']}], 'interventions': [{'name': 'Nutrition and Physical Activity Intervention', 'type': 'BEHAVIORAL', 'description': 'Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.\n\nChildren. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play.', 'armGroupLabels': ['Nutrition and Physical Activity Intervention']}, {'name': 'English for Second Language Intervention', 'type': 'OTHER', 'description': 'Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.\n\nChildren. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons.', 'armGroupLabels': ['English for Second Language Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Hudson Santos, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hudson Santos', 'investigatorAffiliation': 'University of Miami'}}}}