Virtual Housecalls: Redesigning Pediatric Primary Care Adolescent Obesity Treatment (VHC)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric Obesity; Class I Obesity
• Intervention / Treatment: Behavioral: Virtual Housecalls

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melanie K Bean, PhD; Phone Number: 804-527-4765; Email: melanie.bean@vcuhealth.org
• Study Contact Backup: Name: Sarah M Farthing, MS; Phone Number: 804-527-4756; Email: sarah.malone@vcuhealth.org

Study Locations

• United States
  • Virginia
    • Henrico, Virginia, United States, 23239
      • Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Adolescent Inclusion Criteria:

• English or Spanish-speaking
• 12-15 years of age
• Receiving care at a participating clinic
• Body Mass Index (BMI) ≥95% and <120% of the 95%
• Access to a mobile device with a webcam that can receive texts

Parent Inclusion Criteria:

• English or Spanish-speaking
• Primary legal guardian ≥18 years of age living with the adolescent

Exclusion Criteria:

• conflicts that would inhibit the ability to participate in all aspects of the study as outlined in the study protocol
• family plans to move outside of the study area or plans to no longer be a patient at a participating clinic in the 12 month study period
• the primary care provider or PI determines that the study is not clinically or medically appropriate (e.g., significant psychiatric, cognitive, physical or developmental conditions that would impair their ability to complete assessments, participate in study sessions, or conduct physical activity) based on screening at study onset
• adolescent exhibits severe dietary restriction or compensatory behavior (e.g., vomiting, laxative abuse) based on screening at study onset and clinical interview by a study psychologist
• adolescent is currently pregnant/plans to become pregnant during study period
• adolescent is participating in another weight loss program, has had or plans to undergo weight loss surgery
• adolescent has a chronic medical condition(s) and/or uses medication that substantially impacts or interferes with growth, appetite, weight or physical activity participation
• adolescents taking anti-obesity medication are ineligible if they are not a stable dose for at least 3 months prior to study participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Housecalls Intervention (VHC); Includes standard in-person pediatric primary care, 6 months of telehealth sessions with a behavior coach (3 months with weekly sessions, 3 months with bi-weekly sessions), and weekly exercise videos sent electronically for the 6 month intervention. Sessions include real-time skill building that uses items or space in families' home to tailor the treatment and personalize content application to their context.	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
No Intervention: Enhanced Treatment as Usual (TAU+); Includes standard in-person pediatric primary care, enhanced with PPCP training on obesity treatment guidelines and publicly available education regarding healthy eating and exercise, delivered to participants on a contact schedule matched to the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index (BMI) Change	Adolescent height (cm) and weight (kg) will be measured in triplicate by trained staff wo are masked to treatment assignment. Height and weight values will be used to calculate Body Mass Index (BMI) specific to age and sex using the Centers for Disease and Control reference data.	0 - 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index (BMI) Maintenance	Adolescent height (cm) and weight (kg) will be measured in triplicate by trained staff wo are masked to treatment assignment. Height and weight values will be used to calculate Body Mass Index (BMI) specific to age and sex using the Centers for Disease and Control reference data.	6 - 12 months
Energy Intake	Dietary intake (kilocalories/day); total of 1, 24-hour recall per assessment time point. Recalls will be obtained using the Automated Self-Administered 24-hour (ASA-24) dietary assessment tool with the assistance of trained staff who are masked to treatment assignment. Assessment time points include baseline (0), 6-month, and 12-months.	0-6-months, 6-12-months
Diet Quality	The Healthy Eating Index (HEI) will be used to measure diet quality using 1, 24-hour recall per assessment time point. Recalls will be obtained using the Automated Self-Administered 24-hour (ASA-24) dietary assessment tool with the assistance of trained staff who are masked to treatment assignment. HEI scores will be calculated from the ASA-24 recall data. Assessment time points include baseline (0), 6-month, and 12-months.	0-6-months, 6-12-months
Physical Activity	The Physical Activity Questionnaire for Adolescents (PAQ-A) will assess changes in time spent participating in moderate to vigorous physical activity (MVPA).	0-6-months, 6-12-months
Treatment Dose	Treatment dose(s) (number and contact time) to yield Body Mass Index (BMI) reductions will be explored. Treatment dose includes all intervention components: 1) parent-teen dyad sessions, 2) parent-only sessions, 3) exercise videos, and 4) standard of care medical visits with pediatric provider.	0-6-months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Melanie K Bean, PhD, Virginia Commonwealth University; Principal Investigator: Shari Barkin, PhD, Emory University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): January 31, 2030

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Lifestyle Intervention
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Pediatric Obesity
• Other Study ID Numbers: HM300000084; R01DK144911 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No