HomeGrown Program for Down Syndrome

(HomeGrown Trial)

Overseen By Emily C Clarke

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Tube feeding reliance

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called HomeGrown to improve the health of young children with Down syndrome. It focuses on helping families make healthier choices at home, such as better eating and more physical activity, tailored specifically for children with Down syndrome. Families will be randomly assigned to one of two groups: one will start the HomeGrown program immediately, and the other will begin after six months. This trial may suit primary caregivers of children aged 2-6 with Down syndrome who are not reliant on tube feeding and have access to Wi-Fi or a smartphone. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance the well-being of children with Down syndrome.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the HomeGrown program is safe for young children with Down syndrome?

Research has shown that the HomeGrown program helps young children with Down syndrome develop healthy habits. This program focuses on improving nutrition and encouraging physical activity without using drugs or medical procedures. Consequently, it carries no known risks or side effects typically associated with medical treatments. Instead, the program guides families in making healthier lifestyle choices, which is generally safe as it involves only improved routines, not new substances or procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HomeGrown program for Down syndrome because it offers a new approach that focuses on personalized interventions rather than medication. Unlike the standard treatments that often involve a combination of therapies like speech, occupational, and physical therapy, the HomeGrown program aims to create a tailored plan that fits each participant’s unique needs. This individualized approach could lead to more effective and engaging ways to support development in people with Down syndrome. Additionally, by incorporating a holistic strategy, the HomeGrown program could potentially enhance overall quality of life and long-term outcomes.

What evidence suggests that the HomeGrown program is effective for improving health in young children with Down syndrome?

Research shows that the HomeGrown program helps young children with Down syndrome by promoting healthy eating and exercise. Early results suggest that this family-focused program addresses important gaps in current health programs for these children. Participants in this trial will either receive the HomeGrown program immediately or join a waitlist control, receiving the program after a 6-month delay. While specific data on the program's effectiveness is still being collected, it aims to create lasting and widespread improvements in healthy habits. By customizing the program to meet the needs of children with Down syndrome, it has the potential to significantly change their daily health routines. ^{1 2 6 7 8}

Who Is on the Research Team?

Eric Willis, PhD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for primary caregivers of children aged 2-6 with Down syndrome. It aims to support families in creating a healthier home environment by focusing on nutrition and physical activity. Caregivers must be willing to participate in the study's activities and follow-up.

Inclusion Criteria

I can understand and agree to the study's procedures and risks.

I am between 2 and 6 years old.

I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

R61 Feasibility Phase

38 primary caregivers of children with Down syndrome are enrolled in a 6-month randomized controlled trial to assess feasibility of the HomeGrown program.

6 months

Baseline and 6-month follow-up visits

R33 Efficacy Phase

Assessment of the efficacy of the HomeGrown program in improving family practices related to nutrition and physical activity.

6 months

Follow-up

Participants are monitored for retention and engagement with the HomeGrown program.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HomeGrown

Trial Overview

The 'HomeGrown' program, which promotes healthful changes at home, is being tested against a waitlist control group. The study will measure how well families can engage with the program and its impact on family practices related to healthy eating and physical activity.

How Is the Trial Designed?

Group I: Arm 1- HomeGrown program Experimental Treatment 1 Intervention

Participants will receive interventions.

Group II: Arm 2 Waitlist control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1.

reporter.nih.gov

reporter.nih.gov/project-details/11129256

Home Grown: A family-based lifestyle intervention to support ...

In the R33 phase, the efficacy of the HomeGrown program will be assessed with 208 primary caregivers with a young child (2-6 years old) with Down syndrome.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07296861

HomeGrown: A Family-based Lifestyle Intervention to ...

Data Collection & Retention: Achieve at least 80% retention with completion of all outcome assessments. By addressing key gaps in nutrition and ...

3.

hpdp.unc.edu

hpdp.unc.edu/current-research/home-grown-a-family-based-lifestyle-intervention-to-support-healthy-development-of-young-children-with-down-syndrome/

Home Grown: A family-based lifestyle intervention to support ...

The project's findings have the potential to inform sustainable, scalable programs that improve health outcomes for these children.

4.

trial.medpath.com

trial.medpath.com/clinical-trial/502806aef947f5cb/nct07296861-family-based-lifestyle-intervention-down-syndrome-children

HomeGrown: A Family-based Lifestyle Intervention to Support ...

The goal of this project is to evaluate an adapted health promotion program, HomeGrown, designed to improve the health of young children ...

5.

hpdp.unc.edu

hpdp.unc.edu/2025/09/chwr-team-researchers-awarded-nih-grant-to-support-healthy-growth-of-young-children-with-down-syndrome/

CHWR Team Researchers Awarded NIH Grant to Support ...

Outcomes will focus on accrual, engagement, and retention rates, as well as preliminary measures of children's diet quality, physical activity, ...

6.

nichd.nih.gov

nichd.nih.gov/newsroom/news/102324-INCLUDE-cohort

NIH establishes $20 million program to study Down syndrome ...

The National Institutes of Health (NIH) recently launched a new long-term study to observe and track health data of people with Down syndrome from birth to ...

7.

homegrownchildcare.org

homegrownchildcare.org/wp-content/uploads/2022/08/HomeGrown-Erikson-BENCHMARKS-BRIEF-Final.pdf

An Evidence-based Framework for High-Quality

Home Grown is a national collaborative of philanthropic leaders committed to improving the quality of and access to home-based child care. We use numerous.

8.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/dmcn.15891

Home participation and personal and environmental ...

All data were confidential and all procedures strictly followed the rules of the local ethics committee regarding data collection and storage.