Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-01 @ 5:17 PM
Study NCT ID:
NCT02739334
Status:
UNKNOWN
Last Update Posted:
2016-04-15
First Post:
2016-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PALS-CATCH Intervention for Obesity Prevention Among At-risk Toddlers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'lastUpdateSubmitDate': '2016-04-14', 'studyFirstSubmitDate': '2016-03-24', 'studyFirstSubmitQcDate': '2016-04-14', 'lastUpdatePostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in child Body Mass Index', 'timeFrame': 'baseline and 10 weeks'}], 'secondaryOutcomes': [{'measure': 'change in intake of servings of sugar sweetened beverages for the child as assessed using 24 hour parent-reported recalls', 'timeFrame': 'baseline and 10 weeks', 'description': 'investigators will assess intake of sugar sweetened beverages per day as collected using multiple 24 hour recalls with the parents conducted by trained interviewers.'}, {'measure': 'change in total intake of servings fruits and vegetables for the child as assessed using 24 hour parent-reported recalls', 'timeFrame': 'baseline and 10 weeks', 'description': 'investigators will assess total intake of servings of fruit and vegetable per day as collected using multiple 24 hour recalls with the parents conducted by trained interviewers.'}, {'measure': 'change in daily minutes of physical activity for the child as assessed using accelerometers', 'timeFrame': 'baseline and 10 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Childhood Obesity']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to learn whether a combination of two research-proven programs, a responsive caregiving parenting program and a childhood obesity prevention program, will have an effect on toddlers' healthy nutrition and physical activity behaviors. Investigators hypothesize that the children participating in the intervention will have significantly lower BMI z-scores, lower intake of sugar sweetened beverages, and increased number of servings of fruits and vegetables, and minutes of physical activity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Months', 'minimumAge': '24 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* child is 2 - 3 years at the time of enrollment\n* child is \\>85th percentile for BMI\n* ability of the parents to speak and read in English at the 4th grade level\n* provide primarily in-home care for the children at the time of enrollment\n* child is Medicaid eligible\n\nExclusion Criteria:\n\n* acute secondary complications of obesity for child (e.g., severe respiratory insufficiency)\n* child with endocrine abnormalities\n* child with severe obesity (\\>99.5th BMI percentile)\n* children who have participated in an obesity treatment program within the past year\n* parent with significant sensory impairments (e.g. deaf, blind)\n* parent with BMI \\>40.0'}, 'identificationModule': {'nctId': 'NCT02739334', 'acronym': 'ENRICH', 'briefTitle': 'PALS-CATCH Intervention for Obesity Prevention Among At-risk Toddlers', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'PALS-CATCH Intervention for Obesity Prevention Among At-risk Toddlers', 'orgStudyIdInfo': {'id': 'HSC-MS-15-0293'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ENRICH', 'description': "The intervention will integrate the Play and Learning Strategies (PALS) program, a 10-week home-based parent-centered curriculum designed to facilitate parents' mastery of skills for interacting with their toddler with Coordinated Approach To Child Health (CATCH), a behaviorally-based school health promotion program based on Social Cognitive Theory (SCT) to increase opportunities for healthy eating and activity.", 'interventionNames': ['Behavioral: ENRICH']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control - monthly handouts', 'description': 'The control group receives monthly handouts (one per month) for 3 months that provides information on various topics including child cognitive and language development and child behaviors as it pertains to 2 and 3 year old children.', 'interventionNames': ['Behavioral: Control - monthly handouts']}], 'interventions': [{'name': 'ENRICH', 'type': 'BEHAVIORAL', 'description': "The intervention, called ENRICH (Encouraging Nurturing Responsiveness to Improve Child Health), is a 10-week home-based parent-centered curriculum designed to facilitate parents' mastery of skills for interacting with their toddler to increase opportunities for healthy eating and activity. Each weekly session is a 60 minute session implemented by a trained coach.", 'armGroupLabels': ['ENRICH']}, {'name': 'Control - monthly handouts', 'type': 'BEHAVIORAL', 'description': 'The control group receives monthly handouts (one per month) for 3 months that provides information on various topics including child cognitive and language development and child behaviors as it pertains to 2 and 3 year old children.', 'armGroupLabels': ['Control - monthly handouts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shreela Sharma, PhD, RD', 'role': 'CONTACT', 'email': 'Shreela.V.Sharma@uth.tmc.edu', 'phone': '713-500-9344'}], 'facility': 'University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Shreela Sharma, PhD, RD', 'role': 'CONTACT', 'email': 'Shreela.v.sharma@uth.tmc.edu', 'phone': '713-500-9244'}], 'overallOfficials': [{'name': 'Shreela Sharma, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Shreela V Sharma', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}