Ignite Creation Date:
2025-12-22 @ 12:15 PM
Ignite Modification Date:
2025-12-23 @ 1:41 PM
Study NCT ID:
NCT07296861
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-12-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HomeGrown: A Family-based Lifestyle Intervention to Support Healthy Development of Young Children With Down Syndrome
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
HomeGrown: A Family-based Lifestyle Intervention to Support Healthy Development of Young Children With Down Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HomeGrown
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01DK128174 | NIH | None | https://reporter.nih.gov/quic… | View |