Actively Recruiting
HomeGrown: A Family-based Lifestyle Intervention to Support Healthy Development of Young Children With Down Syndrome
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-03-31
38
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
Sponsors
U
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. 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.
CONDITIONS
Official Title
HomeGrown: A Family-based Lifestyle Intervention to Support Healthy Development of Young Children With Down Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Child is between 2 and 6 years old
- Child diagnosed with Down syndrome
- Child is not reliant on tube feeding
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
UNC Center for Health Promotion and Disease Prevention
Chapel Hill, North Carolina, United States, 27599-7426
Actively Recruiting
Research Team
E
Emily C Clarke
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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