HomeGrown: A Family-based Lifestyle Intervention to Support Healthy Development of Young Children With Down Syndrome
NCT ID: NCT07296861
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
38 participants
INTERVENTIONAL
2026-05-31
2027-05-31
Brief Summary
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This 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.
The R61 feasibility phase will address three specific aims:
Accrual: Achieve an enrollment rate of 10 families per month, supporting feasibility for the R33 efficacy phase.
Engagement: Demonstrate that families use at least 70% of available HomeGrown intervention components, measured using the digital behavior change interventions engagement scale.
Data Collection \& Retention: Achieve at least 80% retention with completion of all outcome assessments.
By 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Arm 1- HomeGrown program
Participants will receive interventions.
The HomeGrown
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.
Participants 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.
Arm 2 Waitlist control
Participants will receive interventions after study completion, 6-month delayed start.
Waitlist
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.
Interventions
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The HomeGrown
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.
Participants 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.
Waitlist
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.
Eligibility Criteria
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Inclusion Criteria
* Ability to provide informed consent
* 18 years or older
* Primary caregiver of a child with Down syndrome aged 2 to 6 years old
* Have access to WI-FI or smartphone
* Be able to read and speak English
Children:
* Be 2-6 years old.
* Are diagnosed with Down syndrome
* Are not reliant on tube feeding
Exclusion Criteria
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Eric Willis, PhD
Role: PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Locations
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UNC Center for Health Promotion and Disease Prevention
Chapel Hill, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Emily C Clarke
Role: primary
Related Links
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University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
Other Identifiers
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25-2418
Identifier Type: -
Identifier Source: org_study_id