Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07296861 · ClinicalTrials.gov registry record · NA
HomeGrown: A Family-based Lifestyle Intervention to Support Healthy Development of Young Children With Down Syndrome
A NA study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Recruiting
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT07296861 is a NA study that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 38 participants.
The verdict
NCT07296861, a NA study, is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
Study 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.
Interventions
- OTHER Waitlist
- BEHAVIORAL The HomeGrown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2026-04-16 |
| Est. Completion | 2027-05 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07296861
The ClinicalTrials.gov registry entry for NCT07296861 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Waitlist is the first listed.
NCT07296861 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07296861 about?
NCT07296861 is a clinical study titled "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 health...
What is the current status of trial NCT07296861?
This trial is currently recruiting. It is a NA study. The enrollment target is 38 participants. The study started on 2026-04-16. Estimated completion is 2027-05.
What interventions are being tested in trial NCT07296861?
The interventions under investigation include: Waitlist (OTHER), The HomeGrown (BEHAVIORAL).
Who is sponsoring clinical trial NCT07296861?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.