Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-01-26 @ 3:17 AM
Study NCT ID:
NCT02222766
Status:
COMPLETED
Last Update Posted:
2014-08-21
First Post:
2014-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parents and Tots Together: A Family-Based Obesity Prevention Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-20', 'studyFirstSubmitDate': '2014-08-20', 'studyFirstSubmitQcDate': '2014-08-20', 'lastUpdatePostDateStruct': {'date': '2014-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in body mass index (BMI), adjusted for age and gender', 'timeFrame': 'baseline, post-intervention, 9-month follow-up'}], 'secondaryOutcomes': [{'measure': 'Change in parent general parenting behaviors, i.e., use of positive discipline strategies.', 'timeFrame': 'baseline, post-intervention, 9-month follow-up'}, {'measure': 'Change in child weight-related behaviors, i.e., sleep duration and physical activity, and sugar-sweetened beverage intake and television/video viewing.', 'timeFrame': 'baseline, post-intervention, 9-month follow-up'}, {'measure': 'Change in parental feeding behaviors, i.e., controlling feeding practices', 'timeFrame': 'baseline, post-intervention, 9-month follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': "The obesity epidemic has spared no age group, including our youngest children. My and others' formative research shows that ethnically-diverse, low-income parents of young children are enthusiastic about learning general parenting skills, such as discipline strategies, but less interested in nutrition and physical activity. To capitalize on this enthusiasm, I will create and test an intervention that embeds strategies to improve child weight-related behaviors within a general skills parenting program.\n\nThe overall goal of this study is to assess Parents and Tots Together (PTT), a family-based intervention to prevent obesity among children age 2 through 5 years. To achieve this goal, my colleagues and I will conduct a randomized controlled trial (RCT) among ethnically diverse, primarily low-income families. Our specific aims are to:\n\n1. Determine the extent to which the intervention, compared with a control condition, results in a smaller age-associated increase in body mass index (BMI) among children after a 3- month intervention and a 9-month follow-up period (primary outcome).\n2. Determine the extent to which the intervention, compared with a control condition, results in:\n\n 1. Improved parent general parenting behaviors, i.e., increased use of positive discipline strategies.\n 2. Improved parent feeding practices, i.e., increased responsiveness to child satiety cues.\n 3. Improved child weight-related behaviors, i.e., increased sleep duration and physical activity, and reduced sugar-sweetened beverage intake and television/video viewing."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* parents who have a child aged 2-5 years\n* respond to interviews and questionnaires in English or Spanish\n\nExclusion Criteria:\n\n* any families who plan to move during the study period\n* children or parents with severe health conditions that would prohibit them from participating in study activities'}, 'identificationModule': {'nctId': 'NCT02222766', 'acronym': 'PTT', 'briefTitle': 'Parents and Tots Together: A Family-Based Obesity Prevention Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of Guelph'}, 'officialTitle': 'Parents and Tots Together: A Family-Based Intervention to Promote Healthy Eating and Activity Behaviors Among Preschool Children', 'orgStudyIdInfo': {'id': '190331-41'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parents and Tots Together Program', 'description': '9-week group-based parenting program', 'interventionNames': ['Behavioral: Parents and Tots Together Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Minimal attention control- weekly mailed information on general child development for 9 weeks', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'Parents and Tots Together Program', 'type': 'BEHAVIORAL', 'description': 'Group-based parenting program, 9 sessions offered weekly', 'armGroupLabels': ['Parents and Tots Together Program']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'Minimal attention control- 9 weekly mailed information on general child development', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Harvard Pilgrim Health Care', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Jess Haines, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Guelph'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Guelph', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}, {'name': 'Harvard Medical School (HMS and HSDM)', 'class': 'OTHER'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jess Haines', 'investigatorAffiliation': 'University of Guelph'}}}}