Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-28 @ 8:03 PM
Study NCT ID:
NCT07296861
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HomeGrown: A Family-based Lifestyle Intervention to Support Healthy Development of Young Children With Down Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004314', 'term': 'Down Syndrome'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014850', 'term': 'Waiting Lists'}], 'ancestors': [{'id': 'D001071', 'term': 'Appointments and Schedules'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-12-18', 'studyFirstSubmitQcDate': '2025-12-18', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accrual Rate', 'timeFrame': 'Baseline', 'description': 'Percent of eligible participants who agreed to join study.'}, {'measure': 'Participant Engagement', 'timeFrame': '6 months', 'description': 'Digital behavior change engagement scale will be measured as number of participants completed digital intervention.'}, {'measure': 'Participant Retention', 'timeFrame': '6 months', 'description': 'Percent of participants who completed 6-month measures.'}], 'secondaryOutcomes': [{'measure': 'Child Physical Activity', 'timeFrame': '6 months', 'description': "GT3X+ accelerometers (ActiGraph, Pensacola, FL) are small wearable devices that measure movement and physical activity levels. worn on children's waist for 7 consecutive days. Reminders about wearing and returning the device will be sent via email/text throughout each assessment period. Video instructions will also be available through the web application. Accelerometer data will be used to calculate the number of minutes participants spend in each physical activity level (sedentary, light, moderate, vigorous, and total non-sedentary)."}, {'measure': 'Child Diet Quality', 'timeFrame': '6 months', 'description': "Caregivers will complete 24-hour dietary recalls to report their child's food and beverage intake using the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool. Caregivers will receive a standardized email with login details, instructions, and a prompt to complete the recall, followed by a reminder text on their assigned recall days. If a recall is still not completed, data collectors will make a final attempt to complete it with the caregiver by phone.\n\nUsing the ASA24 output, Healthy Eating Index-Toddlers-2020 (HEI-2020) scores will be calculated. The HEI-2020 reflects how closely a child's diet aligns with dietary guidelines, with scores ranging from 0 to 100; higher scores indicate better diet quality."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['home environmental'], 'conditions': ['Down Syndrome', 'Child Obesity']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://unclineberger.org/patientcare/clinical-trials/clinical-trials', 'label': 'University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials'}]}, 'descriptionModule': {'briefSummary': "The goal of this project is to evaluate an adapted health promotion program, HomeGrown, designed to improve the health of young children with Down syndrome by supporting families in making healthy home environmental changes. There is a significant need for evidence-based programs that address healthy eating and physical activity within this population, as most existing interventions have been developed for typically developing children. By tailoring the program to the unique needs of families of young children with Down syndrome, this project aims to advance inclusion and equity in health behavior promotion.\n\nThis R61/R33 study will assess the feasibility (R61 Phase) and subsequent efficacy (R33 Phase) of the HomeGrown program in improving family practices related to nutrition and physical activity. During the R61 feasibility phase, 38 primary caregivers of children aged 2-6 years with Down syndrome will be enrolled in a 6-month randomized controlled trial. Families will be randomized 1:1 to either the HomeGrown intervention or a waitlist control group (6-month delayed start), stratified by the child's biological sex (male/female) and age (2-3 vs. 4-6 years). All measures will be collected at baseline and at 6-month follow-up.\n\nThe R61 feasibility phase will address three specific aims:\n\nAccrual: Achieve an enrollment rate of 10 families per month, supporting feasibility for the R33 efficacy phase.\n\nEngagement: Demonstrate that families use at least 70% of available HomeGrown intervention components, measured using the digital behavior change interventions engagement scale.\n\nData Collection \\& Retention: Achieve at least 80% retention with completion of all outcome assessments.\n\nBy addressing key gaps in nutrition and physical activity research for young children with Down syndrome, this study has the potential to improve health outcomes for an underserved population and inform future clinical and community health promotion efforts."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult:\n\n* Ability to provide informed consent\n* 18 years or older\n* Primary caregiver of a child with Down syndrome aged 2 to 6 years old\n* Have access to WI-FI or smartphone\n* Be able to read and speak English\n\nChildren:\n\n* Be 2-6 years old.\n* Are diagnosed with Down syndrome\n* Are not reliant on tube feeding\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07296861', 'acronym': 'HomeGrown', 'briefTitle': 'HomeGrown: A Family-based Lifestyle Intervention to Support Healthy Development of Young Children With Down Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'UNC Lineberger Comprehensive Cancer Center'}, 'officialTitle': 'HomeGrown: A Family-based Lifestyle Intervention to Support Healthy Development of Young Children With Down Syndrome', 'orgStudyIdInfo': {'id': '25-2418'}, 'secondaryIdInfos': [{'id': 'R01DK128174', 'link': 'https://reporter.nih.gov/quickSearch/R01DK128174', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1- HomeGrown program', 'description': 'Participants will receive interventions.', 'interventionNames': ['Behavioral: The HomeGrown']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2 Waitlist control', 'description': 'Participants will receive interventions after study completion, 6-month delayed start.', 'interventionNames': ['Other: Waitlist']}], 'interventions': [{'name': 'The HomeGrown', 'type': 'BEHAVIORAL', 'description': 'The implementation model for supporting home environment changes focuses on engaging families in Homegrown, giving them access to interactive online tools and resources that guide behavior change, and providing monthly support check-in calls as they work to adopt evidence-based healthy eating and physical activity practices at home. Families will participate in the 6-month program with support from a trained health educator. The HomeGrown program begins with a family orientation session, followed by access to the HomeGrown web application.\n\nParticipants will have access to HomeGrown intervention which is a 6-month program that helps families improve healthy eating and physical activity at home. Families start with an orientation session, then use the HomeGrown web application with interactive tools and resources. Monthly check-in calls with a trained health educator provide guidance and support throughout the program.', 'armGroupLabels': ['Arm 1- HomeGrown program']}, {'name': 'Waitlist', 'type': 'OTHER', 'description': 'Participants will have a 1-hour training with the interventionist to learn how to use a website (not HomeGrown). Access to HomeGrown will be provided after the 6-month study is completed.', 'armGroupLabels': ['Arm 2 Waitlist control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599-7426', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'contacts': [{'name': 'Emily C Clarke', 'role': 'CONTACT', 'email': 'emily.clarke@unc.edu', 'phone': '336-971-7459'}, {'name': 'Erik Willis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UNC Center for Health Promotion and Disease Prevention', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'centralContacts': [{'name': 'Emily C Clarke', 'role': 'CONTACT', 'email': 'emily.clarke@unc.edu', 'phone': '919-966-6080'}], 'overallOfficials': [{'name': 'Eric Willis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Lineberger Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Individual, de-identified data will be shared in compliance with NIH data sharing policies. They will be shared via the funding institute's required INCLUDE Data Coordinating Center as well as UNC Dataserve."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNC Lineberger Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}