HomeGrown: Family program to support healthy eating and activity for young children with Down syndrome
HomeGrown: A Family-based Lifestyle Intervention to Support Healthy Development of Young Children With Down Syndrome
This program will try a family-based HomeGrown approach to help caregivers of 2–6-year-olds with Down syndrome create healthier home routines for eating and physical activity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT07296861 on ClinicalTrials.gov |
What this trial studies
HomeGrown is a tailored, family-focused program designed to help families of young children with Down syndrome change home environments to support healthy eating and physical activity. The project uses an R61/R33 design, with an initial R61 feasibility phase enrolling 38 primary caregivers in a 6-month randomized comparison of the HomeGrown program versus a waitlist. Content is adapted from general pediatric health-promotion approaches to address the developmental and family needs specific to children with Down syndrome. The goal is to improve caregiver practices and routines around nutrition and movement to reduce obesity risk and promote healthy development.
Who should consider this trial
Good fit: Primary caregivers aged 18 or older of children 2–6 years with a Down syndrome diagnosis who can read and speak English and have access to Wi‑Fi or a smartphone are ideal candidates.
Not a fit: Children outside the 2–6 age range, those who rely on tube feeding, or families unable to use English-language, smartphone-based materials are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could help families adopt healthier routines that improve nutrition and increase activity, lowering obesity risk in young children with Down syndrome.
How similar studies have performed: Most prior healthy eating and activity programs were developed for typically developing children, with limited but promising family-based evidence in special-needs populations, making this tailored approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Adult: * 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: \-
Where this trial is running
Chapel Hill, North Carolina
- UNC Center for Health Promotion and Disease Prevention — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Eric Willis, PhD — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Emily C Clarke
- Email: emily.clarke@unc.edu
- Phone: 919-966-6080
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.