NCT07230808

Digitally Delivered Child Obesity Prevention for Parents in Home Visiting Programs

A Pilot Feasibility Study of Digitally Delivered Modules Focused on Preventing the Development of Obesity During the First Year of Life Within an Existing Statewide Home Visitation Program

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to determine feasibility and acceptability of a digitally-based obesity prevention intervention for mothers of infants participating in a home visitation program. The main questions it aims to answer are: * What impact does the digitally based obesity prevention intervention for parents have on children's weight? * What impact does the digitally based obesity prevention intervention have on mothers' feeding practices, child sleep, and child screen time? Researchers will compare the digital intervention to home visiting standard curriculum to see if the intervention results in larger improvements. Participants will view several digital modules including videos on feeding, activity and family topics over the course of 1 year. They will complete questionnaires at the beginning of the study and again at 4, 6 and 12 months and their child will be weighed and measured at each time point.

Detailed description

The first 1,000 days (conception to age 2) have been deemed a critical period for obesity prevention yet, effective, sustainable efforts are lacking. Current home visitation programs (HVP) targeting at-risk families for other child development related issues are a potential innovative opportunity for early childhood obesity prevention. The overall goal of the project is to reduce the prevalence of overweight and obesity in children under the age of 1 year thereby reducing obesity rates of older children and adults in the long term. Prior pilot work by members of the research team demonstrated feasibility of embedding an early childhood obesity prevention (ECHO) program in an existing home visitation program (HVP+) during an infant's first year of life. Five obesity-associated behaviors (i.e., breastfeeding, introduction to solids, limiting juice, sleep routines, screen time) were emphasized through brief interactive lessons utilizing behavior change strategies and an ecological approach by providing linkages to community resources that support healthy behaviors. The pilot program was well received by families, mothers breastfed longer, infants had fewer nocturnal awakenings, were less likely to receive juice, and had a lower weight-for-length (WFL) z-score at 12 months. However, there is a critical need for alternative and innovative, consistent, and sustainable digital delivery methods especially during times when face-to-face home visits are not feasible. Qualitative interviews were conducted with home visitors (n=27) from Florida's (FL) Maternal, Infant Early Childhood Home Visitation (MIECHV) Program and revealed that they were highly receptive to using digital learning with at-risk families. The specific aims of the proposed research are to a) Develop, refine, and conduct usability testing of early childhood obesity prevention digital learning modules with mothers participating in FL MIECHV; and b) Conduct a pilot RCT of a 12 month digitally-enhanced early childhood obesity prevention intervention (HVP+E), with 50 mother-infant pairs (25 HVP+E/25 standard HVP) participating in FL MIECHV to determine feasibility and acceptability of the HVP+E intervention and study recruitment, implementation and evaluation protocols; and obtain data on preliminary efficacy of the intervention on children's WFL z-scores (primary outcome), maternal feeding practices, child sleep and screen time (secondary outcomes). Mother-infant dyads (n=50) enrolled in the Maternal, Infant Early Childhood Home Visitation (MIECHV) Program parentally or within one month of giving birth will be randomized to receive either the standard home visitation program (HVP) or the digitally delivered obesity prevention-enhanced home visitation program (HVP+E) for 1 year. HVP+E content will also be expanded to support mothers in engaging fathers and other family members in target behaviors. Mother-infant dyads will be assessed at study entry and at 4, 6 and 12 months. If efficacious, the intervention has potential for public health impact through early childhood obesity prevention in an underserved population, and dissemination through home visitation programs nationwide.

Conditions

• Childhood Obesity Prevention

Interventions

Type	Name	Description
BEHAVIORAL	digital intervention + home visiting curriculum	Digitally delivered childhood obesity prevention intervention for parents called THRIVES (Teaching Healthy Routines in Very Early Stages) will be provided to complement the standard home visiting curriculum. Parents will complete digital content containing videos, text and checkpoint questions with goal setting during the first year of their child's life over a 12 month period. Assessments will be collected at baseline, 4, 6 and 12 months.
BEHAVIORAL	Home visiting curriculum	Parents will receive a standard home visiting curriculum delivered in person for at least 1 year during the project timeframe and complete assessments at baseline, 4, 6 and 12 months.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-01
• Completion: 2027-08-01
• First posted: 2025-11-17
• Last updated: 2026-03-04