Virtual Housecalls for Childhood Obesity

(VHC Trial)

Overseen By Melanie K Bean, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Must not be taking: Anti-obesity medications

Disqualifiers: Pregnancy, Weight loss surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist teenagers with obesity through virtual housecalls. The aim is to determine if telehealth sessions with a behavior coach and weekly exercise videos can effectively support healthy lifestyle changes. It includes two groups: one receiving standard care with extra support and another receiving virtual sessions tailored to their home environment. Teens who have been in the overweight range for a while and have access to a mobile device with a webcam may be suitable for this trial. As an unphased trial, this study provides a unique opportunity for teens to explore innovative support methods for healthier living.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking anti-obesity medication, you must be on a stable dose for at least 3 months before joining the study.

What prior data suggests that this intervention is safe for adolescents?

Research has shown that the Virtual Housecalls program for treating adolescent obesity complements regular pediatric care. This innovative approach incorporates online sessions with a behavior coach. While specific safety data from past studies is lacking, the program includes standard practices such as diet and exercise guidance, which are generally safe and well-tolerated.

A data safety and monitoring board oversees the program, ensuring the treatment's safety throughout the study, highlighting a strong commitment to participant safety.

Overall, since this program builds on existing healthcare practices and includes safety oversight, it is expected to be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Housecalls for childhood obesity because it offers a fresh approach to tackling this condition right in the comfort of families' homes. Unlike traditional methods that rely heavily on in-person doctor visits and printed guidelines, this approach uses telehealth sessions with a behavior coach to provide personalized, real-time skill building. The treatment also incorporates unique home-based strategies and weekly exercise videos, making it highly adaptable to individual family environments and routines. This innovative method aims to blend healthcare with everyday life, potentially making it easier for families to adopt healthier habits.

What evidence suggests that the Virtual Housecalls intervention is effective for treating childhood obesity?

Research shows that virtual housecalls, a type of telehealth service, can help manage obesity in teenagers. In this trial, participants in the Virtual Housecalls Intervention (VHC) arm will receive telehealth sessions with a behavior coach, along with exercise videos and personalized skill-building activities. Studies have found that these online methods can improve body mass index (BMI) and promote healthier eating and exercise habits in children. Specifically, a review found that these services helped overweight and obese kids lose weight. While more evidence is needed, especially for younger children, these findings suggest virtual housecalls could be a promising way to tackle obesity in teenagers. ^{1 6 7 8 9}

Who Is on the Research Team?

Shari Barkin, PhD

Principal Investigator

Emory University

Melanie K Bean, PhD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for adolescents with class I obesity who are seeking treatment in pediatric primary care. Specific eligibility details aren't provided, but typically participants must meet certain health criteria to be included.

Inclusion Criteria

My BMI is in the top 5% for my age but not over 20% above that.

Adolescent: Access to a mobile device with a webcam that can receive texts

I am between 12 and 15 years old.

Exclusion Criteria

I am pregnant or planning to become pregnant during the study.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6 months of telehealth sessions with a behavior coach, including 3 months of weekly sessions and 3 months of bi-weekly sessions, along with weekly exercise videos

6 months

Weekly virtual visits for 3 months, bi-weekly virtual visits for 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6 and 12 months

6 months

Assessments at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Housecalls

Trial Overview

The study is testing a new intensive lifestyle and behavior intervention delivered through telehealth aimed at treating class I obesity in young people. It's a randomized trial, meaning participants will be randomly assigned to receive the virtual housecalls or not.

How Is the Trial Designed?

Group I: Virtual Housecalls Intervention (VHC) Experimental Treatment 1 Intervention

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.

Group II: Enhanced Treatment as Usual (TAU+) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07246603

Virtual Housecalls: Redesigning Pediatric Primary Care ...

We will evaluate the efficacy of VHC on adolescent change in body mass index (primary outcome) and dietary and physical activity behaviors ( ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2667368125000506

Evaluating the Long-Term Effectiveness of a Structured ...

This study evaluated the long-term effectiveness of a structured pediatric telehealth intervention compared to historical in-person treatment.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12616204/

Effectiveness of Telehealth and Wearable Device-Based ...

This study systematically reviews the impact of mHealth interventions on body mass index (BMI), adiposity, and related behavioral and ...

4.

nature.com

nature.com/articles/s41366-025-01869-4

An extension study during the COVID-19 pandemic

Currently, there is still limited evidence on the effects of telehealth interventions on obesity outcomes of children in the first 2000 days.

5.

accpjournals.onlinelibrary.wiley.com

accpjournals.onlinelibrary.wiley.com/doi/10.1002/jac5.1495

Review of telehealth interventions for childhood obesity in ...

The purpose of this review is to summarize and evaluate the effectiveness of telehealth modalities on weight loss in overweight/obese children ...

6.

reporter.nih.gov

reporter.nih.gov/project-details/11101323

StEP OUT

Few interventions have improved child obesity related outcomes at ... Virtual Housecalls: Redesigning Pediatric Primary Care Adolescent Obesity Treatment.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06078774

Redesigning Pediatric Primary Care Obesity Treatment ...

Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls.

8.

reporter.nih.gov

reporter.nih.gov/search/-Q0xOf26nke2wtV4PBOkiw/project-details/11237439

Redesigning Pediatric Primary Care Adolescent Obesity ...

PROJECT NARRATIVE This Virtual Housecall model is designed to increase access to and augment primary care models for management of adolescent obesity, ...

9.

researchgate.net

researchgate.net/publication/349007718_Mobile_Health_Apps_in_Pediatric_Obesity_Treatment_Process_Outcomes_From_a_Feasibility_Study_of_a_Multicomponent_Intervention

(PDF) Mobile Health Apps in Pediatric Obesity Treatment

This study aimed to describe process methods for applying an mHealth intervention to reduce the rate of eating and monitor physical activity among children ...