Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:16 AM
Study NCT ID:
NCT04373434
Status:
COMPLETED
Last Update Posted:
2025-10-22
First Post:
2020-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Healthy Homes/Healthy Families (HH/HF) Intervention in 2-1-1 Callers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mkegler@emory.edu', 'phone': '404-712-9957', 'title': 'Michelle C. Kegler, MPH, DrPH', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 12', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Homes/Healthy Families (HH/HF) Intervention', 'description': 'Received a 12-week telephone-based healthy eating and weight gain prevention intervention, Healthy Homes/Healthy Families, that supports households in making changes in their home environment to promote healthy eating.', 'otherNumAtRisk': 253, 'deathsNumAtRisk': 253, 'otherNumAffected': 0, 'seriousNumAtRisk': 253, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Received two mailings post baseline: first mailing included a food diary from the CDC, and healthy eating information from the Dietary Guidelines for Americans 2015-2020; Second mailing included the food diary and healthy eating information from Choose MyPlate', 'otherNumAtRisk': 257, 'deathsNumAtRisk': 257, 'otherNumAffected': 0, 'seriousNumAtRisk': 257, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in United States Department of Agriculture (USDA) Healthy Eating Index (HEI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Homes/Healthy Families (HH/HF) Intervention', 'description': 'Received a 12-week telephone-based healthy eating and weight gain prevention intervention, Healthy Homes/Healthy Families, that supports households in making changes in their home environment to promote healthy eating.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Received two mailings post baseline: first mailing included a food diary from the CDC, and healthy eating information from the Dietary Guidelines for Americans 2015-2020; Second mailing included the food diary and healthy eating information from Choose MyPlate'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.0', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '52.6', 'spread': '12.9', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 (Mean change from baseline )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.38', 'spread': '14.45', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '14.06', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 (Mean change from baseline )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.74', 'spread': '14.57', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '14.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 4, Month 9', 'description': 'Description: The USDA HEI measures diet quality and is calculated from two telephone administered 24-hr dietary recalls (one weekday, one weekend day). The HEI evaluates foods with a scoring system using 13 components for different food groups and the key recommendations of the 2015-2020 "Dietary Guidelines for Americans." Scores range from 0 to 100 where a score of 100 is an ideal score indicating that a diet follows the key recommendations of the 2015-2020 "Dietary Guidelines for Americans" (higher scores indicate better diet quality).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above'}, {'type': 'SECONDARY', 'title': 'Change in Kcal Per Day Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Homes/Healthy Families (HH/HF) Intervention', 'description': 'Received a 12-week telephone-based healthy eating and weight gain prevention intervention, Healthy Homes/Healthy Families, that supports households in making changes in their home environment to promote healthy eating.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Received two mailings post baseline: first mailing included a food diary from the CDC, and healthy eating information from the Dietary Guidelines for Americans 2015-2020; Second mailing included the food diary and healthy eating information from Choose MyPlate'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1736', 'spread': '863.0', 'groupId': 'OG000'}, {'value': '1718', 'spread': '784.5', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 (Mean change)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-206', 'spread': '757', 'groupId': 'OG000'}, {'value': '-80', 'spread': '743', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 (Mean change)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-155', 'spread': '908', 'groupId': 'OG000'}, {'value': '-93', 'spread': '763', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 4, Month 9', 'description': 'Kcal per day will be calculated and recorded. The most recent version of the Automated Self-Administered 24-hour dietary recall (ASA24) program prompts for food description details and automatically codes and calculates nutrient intakes using the USDA Food and Nutrient Database for Dietary Studies. The average of one weekday and one weekend day will be used to estimate Kcal per day at each time point.', 'unitOfMeasure': 'Kcal/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above.'}, {'type': 'SECONDARY', 'title': 'Change in Self-reported Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Homes/Healthy Families (HH/HF) Intervention', 'description': 'Received a 12-week telephone-based healthy eating and weight gain prevention intervention, Healthy Homes/Healthy Families, that supports households in making changes in their home environment to promote healthy eating.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Received two mailings post baseline: first mailing included a food diary from the CDC, and healthy eating information from the Dietary Guidelines for Americans 2015-2020; Second mailing included the food diary and healthy eating information from Choose MyPlate'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '202.3', 'spread': '53.1', 'groupId': 'OG000'}, {'value': '204.1', 'spread': '51.9', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 (Mean change from baseline )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.5', 'spread': '21.74', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '19.31', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 (Mean change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.5', 'spread': '20.64', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '21.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 4, Month 9', 'description': 'Participants will self-report weight in pounds each time point', 'unitOfMeasure': 'weight in pounds (lbs)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above'}, {'type': 'SECONDARY', 'title': 'Changes to Food Environment: UNHEALTHY SNACKS/FOODS INVENTORY, OF 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Homes/Healthy Families (HH/HF) Intervention', 'description': 'Received a 12-week telephone-based healthy eating and weight gain prevention intervention, Healthy Homes/Healthy Families, that supports households in making changes in their home environment to promote healthy eating.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Received two mailings post baseline: first mailing included a food diary from the CDC, and healthy eating information from the Dietary Guidelines for Americans 2015-2020; Second mailing included the food diary and healthy eating information from Choose MyPlate'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.29', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '4.45', 'spread': '1.72', 'groupId': 'OG001'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.12', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '1.90', 'groupId': 'OG001'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.75', 'spread': '2.18', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '2.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 4, Month 9', 'description': 'Participants were asked about unhealthy snacks and foods, ranging from 0 to 8, in each survey of the household food inventory. The higher the number the more unhealthy snacks/foods were reported', 'unitOfMeasure': 'number of unhealthy snacks in the home', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above'}, {'type': 'SECONDARY', 'title': 'Changes to Food Environment: PURCHASING FRUITS/VEGETABLES ≥1/WK', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Homes/Healthy Families (HH/HF) Intervention', 'description': 'Received a 12-week telephone-based healthy eating and weight gain prevention intervention, Healthy Homes/Healthy Families, that supports households in making changes in their home environment to promote healthy eating.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Received two mailings post baseline: first mailing included a food diary from the CDC, and healthy eating information from the Dietary Guidelines for Americans 2015-2020; Second mailing included the food diary and healthy eating information from Choose MyPlate'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.19', 'groupId': 'OG000'}, {'value': '72.37', 'groupId': 'OG001'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '4.7', 'groupId': 'OG001'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}, {'value': '5.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 4, Month 9', 'description': 'A home environment survey assessed the frequency of shopping for or bringing home fruits and vegetables in the past month. Response options were 1=less than once per week, 2=once per week, or 3=more than once per week. Anyone who purchased fruits or vegetables at least once a week was scored as 1, while all others were scored as zero. Reporting includes the percentage of participants who scored 1, i.e., purchased fruits or vegetables at least once a week.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above'}, {'type': 'SECONDARY', 'title': 'Changes to Food Environment: HEALTHY FOOD PREPARATION', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Homes/Healthy Families (HH/HF) Intervention', 'description': 'Received a 12-week telephone-based healthy eating and weight gain prevention intervention, Healthy Homes/Healthy Families, that supports households in making changes in their home environment to promote healthy eating.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Received two mailings post baseline: first mailing included a food diary from the CDC, and healthy eating information from the Dietary Guidelines for Americans 2015-2020; Second mailing included the food diary and healthy eating information from Choose MyPlate'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.10', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '2.12', 'spread': '0.45', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 (mean change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 (mean change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 4, Month 9', 'description': 'Participants were asked about 16 food preparation methods and 3 food serving practices focused on portion control (e.g., use of smaller plates) in the past month. Response options were 1=never/rarely, 2=occasionally, 3=often, and 4=very often. Unhealthy food prep items were reverse-coded, and then all items were averaged. The higher the number, the more frequently healthy food preparation methods were used, and unhealthy food preparation methods were used less frequently', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above'}, {'type': 'SECONDARY', 'title': 'Changes to Food Environment: FAMILY MEALS FROM NONHOME SOURCES, DAYS IN PAST WEEK', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Homes/Healthy Families (HH/HF) Intervention', 'description': 'Received a 12-week telephone-based healthy eating and weight gain prevention intervention, Healthy Homes/Healthy Families, that supports households in making changes in their home environment to promote healthy eating.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Received two mailings post baseline: first mailing included a food diary from the CDC, and healthy eating information from the Dietary Guidelines for Americans 2015-2020; Second mailing included the food diary and healthy eating information from Choose MyPlate'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.27', 'spread': '3.50', 'groupId': 'OG000'}, {'value': '2.88', 'spread': '2.94', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 (mean change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.59', 'spread': '3.59', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '3.02', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 (mean change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.67', 'spread': '4.30', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '3.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 4, Month 9', 'description': 'A home environment survey assessed non-home food sources. Participants were asked how many days in the last week (never, 1-7) they purchased a family meal from four non-home food sources (e.g. fast food, convenience store). The total score was calculated by adding the four types of meals with possible scores ranging from 0 to 28. A higher score indicated more family meals per week from non-home sources.', 'unitOfMeasure': 'meals per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above'}, {'type': 'SECONDARY', 'title': 'Changes to Food Environment: Family Eating and TV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Homes/Healthy Families (HH/HF) Intervention', 'description': 'Received a 12-week telephone-based healthy eating and weight gain prevention intervention, Healthy Homes/Healthy Families, that supports households in making changes in their home environment to promote healthy eating.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Received two mailings post baseline: first mailing included a food diary from the CDC, and healthy eating information from the Dietary Guidelines for Americans 2015-2020; Second mailing included the food diary and healthy eating information from Choose MyPlate'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.65', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '2.58', 'spread': '1.09', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 (mean change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.55', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 (mean change from baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.45', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '1.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 4, Month 9', 'description': 'A home environment survey included two items on meals/snacks eaten with the television on. Response options ranged: 1=never/rarely, 2=occasionally, 3=often, 4=very often. The score was calculated as the mean of both items. A higher score indicates more frequently eaten meals and snacks with the television on.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Homes/Healthy Families (HH/HF) Intervention', 'description': 'Received a 12-week telephone-based healthy eating and weight gain prevention intervention, Healthy Homes/Healthy Families, that supports households in making changes in their home environment to promote healthy eating.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Received two mailings post baseline: first mailing included a food diary from the CDC, and healthy eating information from the Dietary Guidelines for Americans 2015-2020; Second mailing included the food diary and healthy eating information from Choose MyPlate'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '255'}, {'groupId': 'FG001', 'numSubjects': '257'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '220'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'Refused at 9 months', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Refused at 4 months', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Excluded', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from the United Way of Greater Atlanta 2-1-1, United Way of Central Georgia, United Way of the Chattahoochee Valley 2-1-1, and United Way of Southwest Georgia as part of a hybrid effectiveness implementation trial testing an adapted version of the Healthy Homes/Healthy Families healthy eating and weight gain prevention intervention. Participant enrollment began in September 2020, and final follow-up assessments were completed in December 2022.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Homes/Healthy Families (HH/HF) Intervention', 'description': 'Received a 12-week telephone-based healthy eating and weight gain prevention intervention, Healthy Homes/Healthy Families, that supports households in making changes in their home environment to promote healthy eating.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Received two mailings post baseline: first mailing included a food diary from the CDC, and healthy eating information from the Dietary Guidelines for Americans 2015-2020; Second mailing included the food diary and healthy eating information from Choose MyPlate'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '43.8', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '43.0', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '43.4', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '237', 'groupId': 'BG001'}, {'value': '467', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', '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': '250', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '503', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian, Alaska Native Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Unknown or not reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Some participants did not provide information for every baseline characteristic'}, {'title': 'Highest education', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Less than high school', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'High school or GED', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}, {'title': 'Some college/technical school', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}]}, {'title': 'College graduate or higher', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Employment status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Employed', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '281', 'groupId': 'BG002'}]}, {'title': 'Not Employed', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Household income', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'BG000'}, {'value': '246', 'groupId': 'BG001'}, {'value': '487', 'groupId': 'BG002'}]}], 'categories': [{'title': '$10,000 and under', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}, {'title': '$10,001 - $20,000', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}, {'title': '$20,001 - $35,000', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': '$35,001 - $50,000', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'More than $50,000', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Some participants did not provide information for every baseline characteristic.'}, {'title': 'Marital status', 'classes': [{'title': 'Married/living with partner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}, {'title': 'Widowed/separated/divorced', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}, {'title': 'Not married', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-24', 'size': 770012, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-29T15:23', 'hasProtocol': True}, {'date': '2023-10-17', 'size': 274698, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-06T21:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 512}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-07', 'studyFirstSubmitDate': '2020-04-29', 'resultsFirstSubmitDate': '2025-08-07', 'studyFirstSubmitQcDate': '2020-05-01', 'lastUpdatePostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-07', 'studyFirstPostDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in United States Department of Agriculture (USDA) Healthy Eating Index (HEI)', 'timeFrame': 'Baseline, Month 4, Month 9', 'description': 'Description: The USDA HEI measures diet quality and is calculated from two telephone administered 24-hr dietary recalls (one weekday, one weekend day). The HEI evaluates foods with a scoring system using 13 components for different food groups and the key recommendations of the 2015-2020 "Dietary Guidelines for Americans." Scores range from 0 to 100 where a score of 100 is an ideal score indicating that a diet follows the key recommendations of the 2015-2020 "Dietary Guidelines for Americans" (higher scores indicate better diet quality).'}], 'secondaryOutcomes': [{'measure': 'Change in Kcal Per Day Intake', 'timeFrame': 'Baseline, Month 4, Month 9', 'description': 'Kcal per day will be calculated and recorded. The most recent version of the Automated Self-Administered 24-hour dietary recall (ASA24) program prompts for food description details and automatically codes and calculates nutrient intakes using the USDA Food and Nutrient Database for Dietary Studies. The average of one weekday and one weekend day will be used to estimate Kcal per day at each time point.'}, {'measure': 'Change in Self-reported Weight', 'timeFrame': 'Baseline, Month 4, Month 9', 'description': 'Participants will self-report weight in pounds each time point'}, {'measure': 'Changes to Food Environment: UNHEALTHY SNACKS/FOODS INVENTORY, OF 8', 'timeFrame': 'Baseline, Month 4, Month 9', 'description': 'Participants were asked about unhealthy snacks and foods, ranging from 0 to 8, in each survey of the household food inventory. The higher the number the more unhealthy snacks/foods were reported'}, {'measure': 'Changes to Food Environment: PURCHASING FRUITS/VEGETABLES ≥1/WK', 'timeFrame': 'Baseline, Month 4, Month 9', 'description': 'A home environment survey assessed the frequency of shopping for or bringing home fruits and vegetables in the past month. Response options were 1=less than once per week, 2=once per week, or 3=more than once per week. Anyone who purchased fruits or vegetables at least once a week was scored as 1, while all others were scored as zero. Reporting includes the percentage of participants who scored 1, i.e., purchased fruits or vegetables at least once a week.'}, {'measure': 'Changes to Food Environment: HEALTHY FOOD PREPARATION', 'timeFrame': 'Baseline, Month 4, Month 9', 'description': 'Participants were asked about 16 food preparation methods and 3 food serving practices focused on portion control (e.g., use of smaller plates) in the past month. Response options were 1=never/rarely, 2=occasionally, 3=often, and 4=very often. Unhealthy food prep items were reverse-coded, and then all items were averaged. The higher the number, the more frequently healthy food preparation methods were used, and unhealthy food preparation methods were used less frequently'}, {'measure': 'Changes to Food Environment: FAMILY MEALS FROM NONHOME SOURCES, DAYS IN PAST WEEK', 'timeFrame': 'Baseline, Month 4, Month 9', 'description': 'A home environment survey assessed non-home food sources. Participants were asked how many days in the last week (never, 1-7) they purchased a family meal from four non-home food sources (e.g. fast food, convenience store). The total score was calculated by adding the four types of meals with possible scores ranging from 0 to 28. A higher score indicated more family meals per week from non-home sources.'}, {'measure': 'Changes to Food Environment: Family Eating and TV', 'timeFrame': 'Baseline, Month 4, Month 9', 'description': 'A home environment survey included two items on meals/snacks eaten with the television on. Response options ranged: 1=never/rarely, 2=occasionally, 3=often, 4=very often. The score was calculated as the mean of both items. A higher score indicates more frequently eaten meals and snacks with the television on.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Weight Gain Prevention', 'Cancer Prevention', 'Chronic Conditions', 'Obesity', 'Healthy Eating'], 'conditions': ['Weight Change, Body']}, 'descriptionModule': {'briefSummary': 'This trial will evaluate a healthy eating and weight gain prevention intervention for delivery through calls to the 2-1-1 number.', 'detailedDescription': 'It is now well-established that obesity and excess weight increase the risk of cancer (i.e., colorectal and post-menopausal breast cancer), as well as other chronic diseases including diabetes, stroke, coronary heart disease, and arthritis. The World Cancer Research Fund and the American Institute for Cancer Research state "maintenance of a healthy weight throughout life may be one of the most important ways to protect against cancer". Unfortunately, adults generally gain weight as they age.\n\nHealthy Homes/Healthy Families (HH/HF) Intervention involves a tailored home environment profile and a health coach working with participants to select and implement a series of healthy actions to create a home environment more supportive of healthy eating and physical activity.\n\nThe Federal Communications Commission (FCC) designated 2-1-1 as the 3-digit number to call for information and referrals to social services and other assistance in the United States. This study will evaluate a healthy eating and weight gain prevention intervention for delivery through 2-1-1 calls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 70 years of age\n* able to speak English\n* self-report BMI of 20 and above\n\nExclusion Criteria:\n\n* pregnant women\n* only one member per household will be enrolled'}, 'identificationModule': {'nctId': 'NCT04373434', 'briefTitle': 'Healthy Homes/Healthy Families (HH/HF) Intervention in 2-1-1 Callers', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'A Hybrid Effectiveness-Implementation Study on Weight Gain Prevention Among 2-1-1 Callers', 'orgStudyIdInfo': {'id': 'IRB00112359'}, 'secondaryIdInfos': [{'id': 'CDC-IRB00112359', 'type': 'OTHER', 'domain': 'Centers for Disease Control and Prevention'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Homes/Healthy Families (HH/HF) Intervention', 'description': 'Participants randomized to the HH/HF study intervention will work with a coach through phone calls and text messages for 12 weeks to set goals targeting home-based environmental determinants of dietary behaviors.', 'interventionNames': ['Behavioral: Health Homes/Healthy Families (HH/HF) Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Participants in the control condition will receive two mailings which focus on the same dietary outcomes as the HH/HF intervention but without the home environment emphasis.', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'Health Homes/Healthy Families (HH/HF) Intervention', 'type': 'BEHAVIORAL', 'description': 'The HH/HF Intervention involves coaching calls, text messages and intervention materials that are designed to increase behavioral capability, self-efficacy and behavioral intention to improve the home food environment for healthy eating and weight gain prevention. The intervention is delivered over a 12 week period.', 'armGroupLabels': ['Healthy Homes/Healthy Families (HH/HF) Intervention']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'Participants in the control condition will receive two mailings on healthy eating, the first from the "Dietary Guidelines For Americans 2015-2020, 8th Edition" and the second from "Choose MyPlate". Additionally, both mailings will include a food diary from the Centers for Disease Control and Prevention. Mailings will be sent to participants one and six-weeks post-baseline. These materials focus on the same dietary outcomes being targeted in the HH/HF intervention, but without the home environment emphasis. Control group participants will receive their home environment profile with a list of healthy actions upon completion of the study.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University, Rollins School of Public Health', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Michelle Kegler, DrPH/MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Six months after publication of the primary results data will become available', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results, after de-identification will be shared', 'accessCriteria': 'Researchers should send a methodologically sound proposal to mkegler@emory.edu. To gain access, requesters will need to sign a data access agreement. Upon approval, data will be shared via a secure website such as Box'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Michelle C. Kegler', 'investigatorAffiliation': 'Emory University'}}}}