Home Grown: A family-based lifestyle intervention to support healthy development of young children with Down syndrome

While it is well established that healthy eating and physical activity habits are formed early and influence immediate and long-term chronic health condition risk, there is an absence of available and accessible prevention and control programs for families of young children with Down syndrome, who have disproportionately higher rates of chronic health conditions compared to their typically developing peers. The development of early childhood interventions tailored to address health behaviors for this population are essential and would provide significant improvement in their overall well-being and quality of life. Therefore, the goal of this R61/R33 project is to evaluate an adapted healthy lifestyle program, HomeGrown, specifically tailored for families of young children with Down syndrome for its feasibility (R61 Phase) and efficacy (R33 Phase) in improving practices around healthy eating and physical activity. The proposed project is highly responsive to RFA-OD-22-010 seeking clinical trial development for co-occurring conditions in individuals with Down syndrome. As part of the R61 phase, feasibility of conducting a randomized control trial will be assessed with 38 primary caregivers of a young child (2-6 years old) with Down syndrome. Participants will be randomized (1:1), stratified by child's biological sex (male/female) and age (2-3; 4-6 years old), to either the HomeGrown intervention or a waitlist control (6-month delayed start). The primary outcome is feasibility of the HomeGrown program characterized by accrual, engagement, and retention rates. Secondary study measures consist of children's diet quality and physical activity and families' use of evidence-based healthy eating and physical activity practices. 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. Participants will be randomized (1:1), stratified by child's biological sex (male/female) and age (2-3; 4-6 years old), to either the HomeGrown intervention or a waitlist control (6-month delayed start). The primary outcomes measures will assess children's diet quality and physical activity between baseline and post-intervention; secondary outcomes include families' use of evidence-based healthy eating and physical activity practices. Guided by the RE-AIM framework, process data collected in both phases will be used to assess reach, representativeness, adoption, and satisfaction. Measures for both phases will be collected at baseline (0 months) and post-intervention (6-months). The proposed study fills key research gaps in health promotion initiatives for families of young children with Down syndrome, who are underrepresented in nutrition and physical activity research and underserved in clinical practice. Project Number: 1R61HD118439-01 | Fiscal Year: 2025 | NIH Institute/Center: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator: Erik Willis | Institution: UNIV OF NORTH CAROLINA CHAPEL HILL, CHAPEL HILL, NC | Award Amount: $1,017,548 | Activity Code: R61 | Study Section: Special Emphasis Panel[ZRG1 IVBH-A (56)] View on NIH RePORTER: https://reporter.nih.gov/project-details/1R61HD11843901