Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT03433456
Status:
COMPLETED
Last Update Posted:
2024-10-29
First Post:
2018-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Healthy Homes, Healthy Habits
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D006184', 'term': 'Habits'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gdutton@uabmc.edu', 'phone': '205.934.6876', 'title': 'Dr. Gareth Dutton', 'organization': 'University of Alabama at Birmingham'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to COVID-19, there were protocol changes to the study and no data available for some of the 6-month study visits.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Home Visitation + HABITS Program: Caregivers', 'description': "The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.\n\nHome visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.", 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 0, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Home Visitation + HABITS Program: Children', 'description': "The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.\n\nHome visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.", 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 0, 'seriousNumAtRisk': 79, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Standard Home Visitation Program: Caregivers', 'description': "Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.", 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 0, 'seriousNumAtRisk': 69, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Standard Home Visitation Program: Children', 'description': "Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.", 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 0, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Weight of Mothers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Home Visitation + HABITS Program', 'description': "The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.\n\nHome visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development."}, {'id': 'OG001', 'title': 'Standard Home Visitation Program', 'description': "Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.65', 'spread': '26.04', 'groupId': 'OG000'}, {'value': '97.43', 'spread': '31.29', 'groupId': 'OG001'}]}]}, {'title': '6-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.96', 'spread': '27.01', 'groupId': 'OG000'}, {'value': '96.52', 'spread': '28.97', 'groupId': 'OG001'}]}]}, {'title': '12-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.94', 'spread': '23.78', 'groupId': 'OG000'}, {'value': '98.75', 'spread': '30.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Body weight (kg) at baseline and follow-up assessments.', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.'}, {'type': 'PRIMARY', 'title': 'Weight of Children', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Home Visitation + HABITS Program', 'description': "The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.\n\nHome visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development."}, {'id': 'OG001', 'title': 'Standard Home Visitation Program', 'description': "Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.88', 'spread': '3.80', 'groupId': 'OG000'}, {'value': '14.23', 'spread': '5.10', 'groupId': 'OG001'}]}]}, {'title': '6-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.40', 'spread': '3.76', 'groupId': 'OG000'}, {'value': '15.94', 'spread': '5.21', 'groupId': 'OG001'}]}]}, {'title': '12-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.83', 'spread': '3.95', 'groupId': 'OG000'}, {'value': '17.58', 'spread': '5.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Body weight (kg) at baseline and follow-up assessments..', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.'}, {'type': 'SECONDARY', 'title': 'Habit Strength of Targeted Behaviors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Home Visitation + HABITS Program', 'description': "The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.\n\nHome visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development."}, {'id': 'OG001', 'title': 'Standard Home Visitation Program', 'description': "Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development."}], 'classes': [{'title': 'Baseline- Fruit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.58', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '3.67', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': '6-month- Fruit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.86', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '3.95', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': '12-month- Fruit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.91', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '4.26', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Baseline-Vegetables', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.72', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '3.79', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': '6-month-Vegetables', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.91', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '4.07', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': '12-month-Vegetables', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.02', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '4.18', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Baseline-Fried Food', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.30', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '2.99', 'spread': '1.01', 'groupId': 'OG001'}]}]}, {'title': '6-month-Fried Food', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.95', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '2.89', 'spread': '1.10', 'groupId': 'OG001'}]}]}, {'title': '12-month-Fried Food', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.96', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '3.13', 'spread': '1.09', 'groupId': 'OG001'}]}]}, {'title': 'Baseline-SSB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.41', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '3.13', 'spread': '1.18', 'groupId': 'OG001'}]}]}, {'title': '6-month-SSB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.80', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '2.98', 'spread': '1.13', 'groupId': 'OG001'}]}]}, {'title': '12-month-SSB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.19', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '3.27', 'spread': '1.20', 'groupId': 'OG001'}]}]}, {'title': 'Baseline-Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.09', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '3.99', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': '6-month-Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.12', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '4.08', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': '12-month-Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.13', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '4.29', 'spread': '0.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Habit strength for caregivers will be assessed using the Self-Reported Habit Index (SRHI) specific to target behaviors on a scale from 1-5 with scores of 5 indicating higher caregiver habit strength for the target behavior.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.'}, {'type': 'SECONDARY', 'title': 'Household Environment Assessing the Number of Different Food Items Available', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Home Visitation + HABITS Program', 'description': "The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.\n\nHome visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development."}, {'id': 'OG001', 'title': 'Standard Home Visitation Program', 'description': "Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development."}], 'classes': [{'title': 'Baseline-Fruit Availability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.01', 'spread': '3.14', 'groupId': 'OG000'}, {'value': '5.64', 'spread': '3.75', 'groupId': 'OG001'}]}]}, {'title': '6-month-Fruit Availability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.00', 'spread': '3.89', 'groupId': 'OG000'}, {'value': '5.58', 'spread': '3.40', 'groupId': 'OG001'}]}]}, {'title': '12-month-Fruit Availability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.28', 'spread': '3.11', 'groupId': 'OG000'}, {'value': '5.66', 'spread': '2.72', 'groupId': 'OG001'}]}]}, {'title': 'Baseline-Vegetable Availability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.46', 'spread': '3.66', 'groupId': 'OG000'}, {'value': '7.29', 'spread': '3.65', 'groupId': 'OG001'}]}]}, {'title': '6-month-Vegetable Availability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.69', 'spread': '4.01', 'groupId': 'OG000'}, {'value': '7.89', 'spread': '4.56', 'groupId': 'OG001'}]}]}, {'title': '12-month-Vegetable Availability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.14', 'spread': '3.83', 'groupId': 'OG000'}, {'value': '7.34', 'spread': '3.37', 'groupId': 'OG001'}]}]}, {'title': 'Baseline-Fried Food', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.61', 'spread': '3.05', 'groupId': 'OG000'}, {'value': '3.30', 'spread': '2.41', 'groupId': 'OG001'}]}]}, {'title': '6-month-Fried Food', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.72', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '3.71', 'spread': '2.15', 'groupId': 'OG001'}]}]}, {'title': '12-month-Fried Food', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.08', 'spread': '2.68', 'groupId': 'OG000'}, {'value': '3.71', 'spread': '2.36', 'groupId': 'OG001'}]}]}, {'title': 'Baseline-SSB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.44', 'spread': '2.89', 'groupId': 'OG000'}, {'value': '3.84', 'spread': '2.27', 'groupId': 'OG001'}]}]}, {'title': '6-month-SSB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.26', 'spread': '2.66', 'groupId': 'OG000'}, {'value': '4.09', 'spread': '2.37', 'groupId': 'OG001'}]}]}, {'title': '12-month-SSB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.96', 'spread': '2.43', 'groupId': 'OG000'}, {'value': '3.68', 'spread': '2.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Household environment assessing the number of different food items available in the home of the caregiver will be assessed using a modified Home Food Assessment (HFA) relating to the 4 food-related target behaviors (fruits, vegetables, sugary beverages, and fried foods). Higher values indicate more different food items in that category (fruits, vegetables, sugary beverages, and fried foods) are available within the home.', 'unitOfMeasure': 'Available food items', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.'}, {'type': 'SECONDARY', 'title': 'Household Environment Assessing the Number of Different Activity-promoting Items Available', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Home Visitation + HABITS Program', 'description': "The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.\n\nHome visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development."}, {'id': 'OG001', 'title': 'Standard Home Visitation Program', 'description': "Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.96', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '3.81', 'spread': '1.58', 'groupId': 'OG001'}]}]}, {'title': '6-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.59', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '4.40', 'spread': '2.15', 'groupId': 'OG001'}]}]}, {'title': '12-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.30', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '4.74', 'spread': '2.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Household environment assessing the number of different activity-promoting items available in the home of the caregiver will be assessed using a modified Home - Inventory Describing Eating and Activity Development (H-IDEA) form. Higher values indicate more availability of different activity-promoting items in the home.', 'unitOfMeasure': 'Available activity items', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Maternal Eating Practices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Home Visitation + HABITS Program', 'description': "The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.\n\nHome visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development."}, {'id': 'OG001', 'title': 'Standard Home Visitation Program', 'description': "Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development."}], 'classes': [{'title': 'Baseline-Fruit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.67', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '2.33', 'spread': '1.36', 'groupId': 'OG001'}]}]}, {'title': '6-month-Fruit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.11', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '2.57', 'spread': '1.38', 'groupId': 'OG001'}]}]}, {'title': '12-month-Fruit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.94', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '2.94', 'spread': '1.61', 'groupId': 'OG001'}]}]}, {'title': 'Baseline-Vegetable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.99', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '2.49', 'spread': '1.35', 'groupId': 'OG001'}]}]}, {'title': '6-month-Vegetable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.61', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '2.66', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': '12-month-Vegetable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.73', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '2.84', 'spread': '1.43', 'groupId': 'OG001'}]}]}, {'title': 'Baseline-Fried Food', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.96', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': '6-month-Fried Food', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.65', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '1.14', 'groupId': 'OG001'}]}]}, {'title': '12-month-Fried Food', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.38', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '1.35', 'spread': '1.17', 'groupId': 'OG001'}]}]}, {'title': 'Baseline-Soda', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.35', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '1.72', 'spread': '1.89', 'groupId': 'OG001'}]}]}, {'title': '6-month-Soda', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.52', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '1.48', 'spread': '1.57', 'groupId': 'OG001'}]}]}, {'title': '12-month-Soda', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.66', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '1.77', 'spread': '1.88', 'groupId': 'OG001'}]}]}, {'title': 'Baseline-Walk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.30', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '4.16', 'spread': '1.94', 'groupId': 'OG001'}]}]}, {'title': '6-month-Walk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.25', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '4.78', 'spread': '1.75', 'groupId': 'OG001'}]}]}, {'title': '12-month-Walk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.14', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '4.95', 'spread': '1.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Assessed using modified food and activity frequency measure from the National Health and Nutrition Examination Survey (NHANES), amended to measure target habit behaviors of feeding and activity. Scored on a scale from 0-6 with higher values indicated more frequent consumption of that food or engagement in that behavior.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Maternal Feeding Practices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Home Visitation + HABITS Program', 'description': "The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.\n\nHome visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development."}, {'id': 'OG001', 'title': 'Standard Home Visitation Program', 'description': "Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development."}], 'classes': [{'title': 'Baseline-Fruit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.19', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '4.14', 'spread': '1.88', 'groupId': 'OG001'}]}]}, {'title': '6-month-Fruit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.46', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '4.54', 'spread': '1.45', 'groupId': 'OG001'}]}]}, {'title': '12-month-Fruit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.27', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '4.37', 'spread': '1.54', 'groupId': 'OG001'}]}]}, {'title': 'Baseline-Vegetable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.03', 'spread': '1.87', 'groupId': 'OG000'}, {'value': '3.70', 'spread': '1.74', 'groupId': 'OG001'}]}]}, {'title': '6-month-Vegetable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.81', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '4.02', 'spread': '1.52', 'groupId': 'OG001'}]}]}, {'title': '12-month-Vegetable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.86', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '3.77', 'spread': '1.62', 'groupId': 'OG001'}]}]}, {'title': 'Baseline-Fried Food', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.63', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '2.13', 'spread': '1.37', 'groupId': 'OG001'}]}]}, {'title': '6-month-Fried Food', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.37', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '2.29', 'spread': '1.27', 'groupId': 'OG001'}]}]}, {'title': '12-month-Fried Food', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.28', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '2.11', 'spread': '0.70', 'groupId': 'OG001'}]}]}, {'title': 'Baseline- Soda', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.73', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '1.28', 'groupId': 'OG001'}]}]}, {'title': '6-month-Soda', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.72', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '1.68', 'spread': '1.32', 'groupId': 'OG001'}]}]}, {'title': '12-month-Soda', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.72', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '1.85', 'spread': '1.34', 'groupId': 'OG001'}]}]}, {'title': 'Baseline-Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.43', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '5.22', 'spread': '2.15', 'groupId': 'OG001'}]}]}, {'title': '6-month-Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.46', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '6.09', 'spread': '1.45', 'groupId': 'OG001'}]}]}, {'title': '12-month-Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.04', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '5.92', 'spread': '1.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Assessed using modified food and activity frequency measure from NHANES, amended to measure target habit behaviors of feeding and activity. Scored from 0-7 with higher values indicated more frequent consumption of food or engagement in the behavior.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Caregiver Depressive Symptoms on the Personal Health Questionnaire Depression Scale (PHQ-8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Home Visitation + HABITS Program', 'description': "The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.\n\nHome visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development."}, {'id': 'OG001', 'title': 'Standard Home Visitation Program', 'description': "Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.59', 'spread': '4.19', 'groupId': 'OG000'}, {'value': '4.42', 'spread': '4.39', 'groupId': 'OG001'}]}]}, {'title': '6-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.48', 'spread': '3.64', 'groupId': 'OG000'}, {'value': '3.08', 'spread': '3.56', 'groupId': 'OG001'}]}]}, {'title': '12-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.64', 'spread': '3.56', 'groupId': 'OG000'}, {'value': '3.03', 'spread': '3.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'The Personal Health Questionnaire Depression Scale (PHQ-8), a validated self-report measure of depressive symptoms experienced over the past two weeks, will be administered to caregivers. PHQ-8 scores range from 0-24, higher scores indicate higher caregiver depressive symptoms.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Caregivers With Changes to Their Medical History', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Home Visitation + HABITS Program', 'description': "The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.\n\nHome visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development."}, {'id': 'OG001', 'title': 'Standard Home Visitation Program', 'description': "Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development."}], 'classes': [{'title': '6-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Had a change to medical history in last 6-months', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'No change to medical history in last 6-months', 'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': '12-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Had a change to medical history in last 6-months', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'No change to medical history in last 6-months', 'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months, 12 months', 'description': 'Self-reported changes to medical history for caregivers (caregiver illnesses, etc.) will be collected.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Home Visitation + HABITS Program', 'description': "The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.\n\nHome visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development."}, {'id': 'FG001', 'title': 'Standard Home Visitation Program', 'description': "Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'This is the total number of caregivers and children who started the study.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '138'}]}, {'type': 'Caregivers Started', 'comment': 'Number of caregivers only who started the study.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'Children Started', 'comment': 'Number of children only who started the study.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'Caregivers Completed', 'comment': 'Number of caregivers only who completed the study.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'Children Completed', 'comment': 'Number of children only who completed the study.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'comment': 'This is the total number of caregivers and children who completed the study.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '126'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Pt in ICU and unable to complete follow-up visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '296', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Home Visitation + HABITS Program', 'description': "The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.\n\nHome visitation + HABITS program: The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development."}, {'id': 'BG001', 'title': 'Standard Home Visitation Program', 'description': "Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.\n\nStandard home visitation program: Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Children', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.'}, {'title': 'Age, Continuous', 'classes': [{'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31.52', 'spread': '6.83', 'groupId': 'BG000'}, {'value': '32.52', 'spread': '9.66', 'groupId': 'BG001'}, {'value': '31.98', 'spread': '8.26', 'groupId': 'BG002'}]}]}, {'title': 'Children', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.71', 'spread': '1.24', 'groupId': 'BG000'}, {'value': '2.59', 'spread': '1.22', 'groupId': 'BG001'}, {'value': '2.66', 'spread': '1.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Children', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Children', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '140', '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': 'Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Children', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Caregiver-child dyads were enrolled in the trial. Data are presented for caregivers and children separately.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-02', 'size': 962665, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2024-02-23T14:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Caregiver-child dyads will be randomized to either the intervention group (receiving home intervention + HABITS program) or the a control group to receive their standard of care (home intervention without HABITS)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 296}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-17', 'studyFirstSubmitDate': '2018-01-31', 'resultsFirstSubmitDate': '2024-02-23', 'studyFirstSubmitQcDate': '2018-02-07', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-27', 'studyFirstPostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Maternal Eating Practices', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Assessed using modified food and activity frequency measure from the National Health and Nutrition Examination Survey (NHANES), amended to measure target habit behaviors of feeding and activity. Scored on a scale from 0-6 with higher values indicated more frequent consumption of that food or engagement in that behavior.'}, {'measure': 'Maternal Feeding Practices', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Assessed using modified food and activity frequency measure from NHANES, amended to measure target habit behaviors of feeding and activity. Scored from 0-7 with higher values indicated more frequent consumption of food or engagement in the behavior.'}, {'measure': 'Caregiver Depressive Symptoms on the Personal Health Questionnaire Depression Scale (PHQ-8)', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'The Personal Health Questionnaire Depression Scale (PHQ-8), a validated self-report measure of depressive symptoms experienced over the past two weeks, will be administered to caregivers. PHQ-8 scores range from 0-24, higher scores indicate higher caregiver depressive symptoms.'}, {'measure': 'Number of Caregivers With Changes to Their Medical History', 'timeFrame': '6 months, 12 months', 'description': 'Self-reported changes to medical history for caregivers (caregiver illnesses, etc.) will be collected.'}], 'primaryOutcomes': [{'measure': 'Weight of Mothers', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Body weight (kg) at baseline and follow-up assessments.'}, {'measure': 'Weight of Children', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Body weight (kg) at baseline and follow-up assessments..'}], 'secondaryOutcomes': [{'measure': 'Habit Strength of Targeted Behaviors', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Habit strength for caregivers will be assessed using the Self-Reported Habit Index (SRHI) specific to target behaviors on a scale from 1-5 with scores of 5 indicating higher caregiver habit strength for the target behavior.'}, {'measure': 'Household Environment Assessing the Number of Different Food Items Available', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Household environment assessing the number of different food items available in the home of the caregiver will be assessed using a modified Home Food Assessment (HFA) relating to the 4 food-related target behaviors (fruits, vegetables, sugary beverages, and fried foods). Higher values indicate more different food items in that category (fruits, vegetables, sugary beverages, and fried foods) are available within the home.'}, {'measure': 'Household Environment Assessing the Number of Different Activity-promoting Items Available', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Household environment assessing the number of different activity-promoting items available in the home of the caregiver will be assessed using a modified Home - Inventory Describing Eating and Activity Development (H-IDEA) form. Higher values indicate more availability of different activity-promoting items in the home.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'low-income', 'health disparities', 'home visitation', 'prevention', 'childhood obesity', 'habit'], 'conditions': ['Obesity', 'Obesity, Childhood', 'Obesity; Familial']}, 'referencesModule': {'references': [{'pmid': '29802965', 'type': 'BACKGROUND', 'citation': 'Salvy SJ, Dutton GR, Borgatti A, Kim YI. Habit formation intervention to prevent obesity in low-income preschoolers and their mothers: A randomized controlled trial protocol. Contemp Clin Trials. 2018 Jul;70:88-98. doi: 10.1016/j.cct.2018.05.015. Epub 2018 May 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether an intervention targeting healthy habit development reduces the risk and prevalence of obesity in low-income mothers and children. The study intends to evaluate whether the intervention, delivered in the context of home visitation services for low-income families, reduces weight gain and risk factors associated with parent and childhood obesity compared to those receiving standard home visitation services.', 'detailedDescription': "Participants will be 140 mothers (\\>50% African American; 100% meet federal poverty level) and their children (n=140; 0-4yo at baseline) (total of N=140 mother-child dyads; i.e., 140 mothers + 140 children = 280 total participants) enrolled in our home visitation partner in central Alabama. Home visitors will be randomly assigned to deliver the home visitation curriculum with or without HABITS (an obesity prevention program targeting key eating and activity behaviors) as part of their monthly home visits for 12 months. Treatment sessions for standard of care or standard + HABITS arms will be facilitated by trained home visitors. If a mother or primary caregiver and her child are randomized to participate in the HABITS + Standard home visitation curriculum, they will receive \\~15 minutes of information, activities, and assistance regarding the development of key behaviors relating to obesity prevention, which will be imbedded within the existing home visitation curriculum. The HABITS program will address habit-formation of four behaviors relevant to mothers or primary caregivers and children: (1) limit fried foods; (2) limit sugar-sweetened beverages (SSB); (3) increase daily steps; (4) increase fruits and vegetables. Additionally, mothers or primary caregivers will also practice habit formation focused on self-monitoring of weight and the four behaviors previously mentioned. Skill training will focus on habit formation and home environment modification conducive to the four behaviors.\n\nMothers or primary caregivers in the intervention group will be provided the HABITS + standard home visitation program for 12 months, while those in the control group will be provided the standard home visitation program during this time. Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '0 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\*Important: Mother (or caregiver) and child dyads are enrolled together. Both must meet inclusion criteria to participate.\n\nMothers or Primary Caregivers:\n\n* Age 18-75 years of age\n* Enrollment in First Teacher Home Visiting Program (First Teacher) through the Family Guidance Center of Alabama.\n* Mother or primary caregiver of 0-4 year old child\n* Generally Healthy\n\nChildren:\n\n* 0-4 years of age at time of enrollment\n* Parent or primary caregiver enrolled in First Teacher\n\nExclusion Criteria:\n\nMothers or primary caregivers:\n\n* Currently enrolled in a diet and weight loss program, AND either a) significant weight loss of 10+ pounds in the last 6 months, OR b) unwilling to discontinue from current diet and weight loss program.\n\nChildren:\n\n* Child has a history of a feeding or eating disorder'}, 'identificationModule': {'nctId': 'NCT03433456', 'acronym': 'HABITS', 'briefTitle': 'Healthy Homes, Healthy Habits', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Leveraging Ongoing Home Visitation Programs to Address Obesity Disparities Among Underserved, Low-Income Mothers and Children', 'orgStudyIdInfo': {'id': '000517527'}, 'secondaryIdInfos': [{'id': '2U54MD000502-15', 'link': 'https://reporter.nih.gov/quickSearch/2U54MD000502-15', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home visitation + HABITS Program', 'description': 'The HABITS module will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children. Participants will receive the HABITS module in addition to their standard home visitation services.', 'interventionNames': ['Behavioral: Home visitation + HABITS program', 'Behavioral: Standard home visitation program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard home visitation program', 'description': 'Participants will receive the standard of care home visitation regularly delivered through the existing home visitation program without the HABITS module.', 'interventionNames': ['Behavioral: Standard home visitation program']}], 'interventions': [{'name': 'Home visitation + HABITS program', 'type': 'BEHAVIORAL', 'description': 'The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.', 'armGroupLabels': ['Home visitation + HABITS Program']}, {'name': 'Standard home visitation program', 'type': 'BEHAVIORAL', 'description': "Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.", 'armGroupLabels': ['Home visitation + HABITS Program', 'Standard home visitation program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Sarah J. Salvy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}, {'name': 'Gareth R. Dutton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'With the documented permission of the IRB, the PI may develop a transportable de-identified database, codebook, and mechanism by which data can be shared with qualified investigators. Interested investigators will be asked to complete a standardized request form stating the specific aims of the analyses, the analytic plan, available resources for completing the proposed project, proposed timeline, and goals (i.e., manuscripts, presentations, and/or grant applications). The PI and research team will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to complete the request, and whether data will be adequately protected and managed. If any of these issues are problematic, the PI and research team will attempt to negotiate a fair resolution with the interested investigators and NIMHD program staff.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Gareth R. Dutton PhD', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}