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NCT Number: NCT07296861

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

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.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Body Weight Child Obesity Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Center for Health Promotion and Disease Prevention

Chapel Hill, North Carolina, 27599-7426, United States

Location status: Recruiting

Location contact

Emily C Clarke

CONTACT

[email protected]

336-971-7459

Erik Willis, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

The HomeGrown

Behavioral

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.

Waitlist

Other

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.

Primary outcomes

  1. Accrual Rate

    Time frame: Baseline

    Percent of eligible participants who agreed to join study.

  2. Participant Engagement

    Time frame: 6 months

    Digital behavior change engagement scale will be measured as number of participants completed digital intervention.

  3. Participant Retention

    Time frame: 6 months

    Percent of participants who completed 6-month measures.

Secondary outcomes

  1. Child Physical Activity

    Time frame: 6 months

    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).

  2. Child Diet Quality

    Time frame: 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily C Clarke

CONTACT

[email protected]

919-966-6080

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: HomeGrown

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 22, 2025
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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