NCT07246603

Virtual Housecalls: Redesigning Pediatric Primary Care Adolescent Obesity Treatment

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 12 Years – 15 Years
• Healthy volunteers: Accepted

Summary

This pragmatic randomized clinical trial tests a novel intensive health behavior and lifestyle intervention, conducted via telehealth, to treat class I adolescent obesity in pediatric primary care. Results will inform scalable approaches that meet the recommended treatment dose and effectively treat obesity in this setting.

Detailed description

This trial will test Virtual Housecalls (VHC) in a pragmatic randomized clinical trial with 250 adolescents ages 12-15 years with class 1 (non-severe) obesity (BMI≥95% and \<120% of the 95%) and a participating parent/caregiver (N=250 dyads / 500 individuals). VHC includes 26 hours of treatment, by combining in-person PPCP visits (every 3m) with 6m of virtual visits conducted by a behavior coach (3m weekly, 3m every 2 weeks), and weekly exercise videos. The control arm will receive enhanced treatment as usual (TAU+), which includes usual care by their pediatric primary care practitioner (PPCP), augmented with publicly available education, sent on an attention-matched contact schedule. All PPCPs will receive training on the AAP Clinical Practice Guideline for obesity treatment and reports of participant progress at 3, 6, and 12m. Assessments of anthropometrics, dietary intake, physical activity, parenting and the home environment will be completed at 0, 3, 6 (post-intervention), and 12m (maintenance), with the primary endpoint at 6m. The investigators will evaluate the efficacy of VHC on adolescent change in body mass index (primary outcome) and dietary and physical activity behaviors (secondary outcomes). Investigators will also evaluate how treatment dose impacts BMI reduction.

Conditions

• Class I Obesity
• Pediatric Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Virtual Housecalls	26 contact hours of evidence-based intensive health and behavioral lifestyle treatment, as per the American Academy of Pediatrics Clinical Practice Guidelines

Timeline

• Start date: 2026-08-01
• Primary completion: 2030-01-01
• Completion: 2030-01-01
• First posted: 2025-11-24
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States