RecruitingNot ApplicableNCT07296861

HomeGrown: A Family-based Lifestyle Intervention to Support Healthy Development of Young Children With Down Syndrome

Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

38 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Down Syndrome Child Obesity

Summary

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.

Eligibility

Inclusion Criteria10

Adult:
Ability to provide informed consent
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 Criteria1

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Interventions

BEHAVIORALThe 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.

OTHERWaitlist

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.