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
N/A
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
Researchers are evaluating an adapted health promotion program called HomeGrown, designed to improve the health of young children with Down syndrome by supporting their families in making healthy changes at home. The study addresses the lack of programs tailored for children with Down syndrome, focusing on healthy eating and physical activity to promote inclusion and equity in health behavior. This project includes two phases: an initial feasibility phase (R61) and a subsequent efficacy phase (R33). During the R61 feasibility phase, 38 primary caregivers of children aged 2 to 6 years with Down syndrome will participate in a 6-month randomized controlled trial. Families will be assigned to either the HomeGrown intervention group, which receives access to interactive online tools, resources, and monthly support calls with a trained health educator, or to a waitlist control group who will receive the intervention after 6 months. The program starts with an orientation session followed by use of the HomeGrown web application. Participants will complete assessments at the start and after 6 months to measure program engagement, retention, and accrual rate. Researchers will also evaluate changes in child physical activity and diet quality. The study aims to achieve high usage of the intervention and retention of participants, with all trial visits and outcome assessments monitored to inform future health promotion efforts for this underserved population.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Primary caregiver of a child with Down syndrome aged 2 to 6 years
- Access to WI-FI or a smartphone
- Ability to read and speak English
- Child aged 2 to 6 years diagnosed with Down syndrome
- Child is not reliant on tube feeding
You will not qualify if you...
- None specified
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Duration - 6 months
Participants start with a family orientation session, then engage with the HomeGrown web application using interactive tools and resources to support healthy eating and physical activity at home. Monthly check-in calls with a trained health educator provide ongoing guidance and support.
1 orientation session and monthly support calls
Duration - 6 months
Participants receive a 1-hour training to learn how to use a website (not HomeGrown) and will access the HomeGrown program after the 6-month study period.
1 training session
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
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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