Virtual Housecalls: Redesigning Pediatric Primary Care Adolescent Obesity Treatment

NCT ID: NCT07246603

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-08-31
• Study Completion Date: 2030-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Housecalls

Intervention Type: BEHAVIORAL

26 contact hours of evidence-based intensive health and behavioral lifestyle treatment, as per the American Academy of Pediatrics Clinical Practice Guidelines

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Housecalls

26 contact hours of evidence-based intensive health and behavioral lifestyle treatment, as per the American Academy of Pediatrics Clinical Practice Guidelines

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melanie K Bean, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Shari Barkin, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Henrico, Virginia, United States

Countries

United States

Central Contacts

Sarah M Farthing, MS

Role: CONTACT

sarah.malone@vcuhealth.org

804-527-4756

Melanie K Bean, PhD

Role: CONTACT

melanie.bean@vcuhealth.org

804-527-4765

Other Identifiers

R01DK144911

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM300000084

Identifier Type: -

Identifier Source: org_study_id