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

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.

Study Overview

• Status: Recruiting
• Conditions: Down Syndrome; Child Obesity
• Intervention / Treatment: Behavioral: The HomeGrown; Other: Waitlist

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily C Clarke; Phone Number: 919-966-6080; Email: emily.clarke@unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7426
      • Recruiting
      • UNC Center for Health Promotion and Disease Prevention
      • Principal Investigator: Erik Willis, PhD
      • Contact: Emily C Clarke; Phone Number: 336-971-7459; Email: emily.clarke@unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1- HomeGrown program; Participants will receive interventions.	Behavioral: The 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.
Active Comparator: Arm 2 Waitlist control; Participants will receive interventions after study completion, 6-month delayed start.	Other: Waitlist; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accrual Rate	Percent of eligible participants who agreed to join study.	Baseline
Participant Engagement	Digital behavior change engagement scale will be measured as number of participants completed digital intervention.	6 months
Participant Retention	Percent of participants who completed 6-month measures.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Physical Activity	GT3X+ accelerometers (ActiGraph, Pensacola, FL) are small wearable devices that measure movement and physical activity levels. worn on children's waist for 7 consecutive days. Reminders about wearing and returning the device will be sent via email/text throughout each assessment period. Video instructions will also be available through the web application. Accelerometer data will be used to calculate the number of minutes participants spend in each physical activity level (sedentary, light, moderate, vigorous, and total non-sedentary).	6 months
Child Diet Quality	Caregivers will complete 24-hour dietary recalls to report their child's food and beverage intake using the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool. Caregivers will receive a standardized email with login details, instructions, and a prompt to complete the recall, followed by a reminder text on their assigned recall days. If a recall is still not completed, data collectors will make a final attempt to complete it with the caregiver by phone. Using the ASA24 output, Healthy Eating Index-Toddlers-2020 (HEI-2020) scores will be calculated. The HEI-2020 reflects how closely a child's diet aligns with dietary guidelines, with scores ranging from 0 to 100; higher scores indicate better diet quality.	6 months

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Eric Willis, PhD, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: home environmental
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Nutrition Disorders; Genetic Diseases, Inborn; Overnutrition; Body Weight; Neurobehavioral Manifestations; Congenital Abnormalities; Abnormalities, Multiple; Overweight; Intellectual Disability; Obesity; Chromosome Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Pediatric Obesity; Down Syndrome; Organization and Administration; Health Services Administration; Appointments and Schedules; Waiting Lists
• Other Study ID Numbers: 25-2418; R01DK128174 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual, de-identified data will be shared in compliance with NIH data sharing policies. They will be shared via the funding institute's required INCLUDE Data Coordinating Center as well as UNC Dataserve.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No