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

UNC Lineberger Comprehensive Cancer Center

Status: Begins enrollment in 2 months

Conditions: Down Syndrome; Child Obesity

Treatments: Other: Waitlist; Behavioral: The HomeGrown

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07296861

R01DK128174 (U.S. NIH Grant/Contract)

25-2418

Details and patient eligibility

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.

Enrollment: 38 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

-

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Arm 1- HomeGrown program

Experimental group

Description:

Participants will receive interventions.

Treatment:

Behavioral: The HomeGrown

Arm 2 Waitlist control

Active Comparator group

Description:

Participants will receive interventions after study completion, 6-month delayed start.

Treatment:

Other: Waitlist