NCT06078774

Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 9 Years
• Healthy volunteers: Not accepted

Summary

This study examines a redesign of pediatric primary care overweight/obesity treatment, augmenting typical in-person visits with: (1) direct-to-patient video telehealth to tailor counseling advice to families, (2) that leverages certified health coaches as a part of the care team, and (3) creates skills building in real-time within the home environment.

Detailed description

Investigators will recruit children with an elevated body mass index (BMI) (85th to \<99th percentile) and a parent. Dyads will participate in a 24-week intervention with a total of 26 contact hours. Dyads will participate in weekly education sessions for the first 12 weeks and bi-weekly sessions for the remaining 12 weeks. Additionally, dyads will participate in weekly exercise sessions. Assessments will consist of anthropometric measures, psychological surveys, and nutritional evaluations. Assessments will be completed at baseline, 3-months and 6-months.

Conditions

• Obesity, Pediatric

Interventions

Type	Name	Description
BEHAVIORAL	Virtual Health Coach	Dyads first session will be 60-minutes, totaling 1 hour. Dyads will participate in weekly 30-minute sessions for weeks 2-12, totaling 5.5 hours. Dyads will participate bi-weekly 30-minute sessions for 12 weeks, totaling 3 hours. Dyads will participate in weekly 30-minute exercise sessions for 24-weeks, totaling 12 hours. Children will have 3, 30-minute visits with their primary care physician (PCP) every 3 months, totaling 1.5 hours. Parents will have three, 60-minute individual sessions, totaling 3 hours. Total study duration is 24 weeks, with a total of 26 contact hours. Sessions follow a behavior therapy approach, including guided goal-setting, self-monitoring, identifying barriers and solutions, contingency management, stimulus control, dealing with setbacks, maintenance and relapse prevention. Weight is assessed weekly by coaches, with MI-consistent, autonomy-supportive feedback provided. Parent sessions will focus on ways to support their child's weight management.

Timeline

• Start date: 2024-01-24
• Primary completion: 2024-08-16
• Completion: 2024-08-16
• First posted: 2023-10-12
• Last updated: 2025-12-23
• Results posted: 2025-12-23

Locations

1 site across 1 country: United States