Recruiting

Health Behavior Intervention

Sponsor:

Virginia Commonwealth University

Code:

NCT07246603

Conditions

Class I Obesity

Pediatric Obesity

Eligibility Criteria

Sex: All

Age: 12 - 15

Healthy Volunteers: Accepted

Interventions

Virtual Housecalls

Study Details

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.

Conditions

Class I Obesity

Pediatric Obesity

Study ID

NCT07246603

Start date

Aug 25, 2026

Status verified date

Aug, 2026

Completion date

Jan 31, 2030

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 15

Healthy Volunteers: Accepted

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 Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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

Primary outcome measure

  • Body Mass Index (BMI) Change [ Time Frame: 0 - 6 months ]

Central Contacts and Locations

Central contacts

Sarah M Farthing, MS

804-527-4756sarah.malone@vcuhealth.org

Melanie K Bean, PhD

804-527-4765melanie.bean@vcuhealth.org

Locations

Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Recruiting

Henrico, Virginia, United States, 23239

Contacts

Sarah M Farthing, MS

804-527-4756sarah.malone@vcuhealth.org

Melanie K Bean, Ph.D.

(804) 527-4765melanie.bean@vcuhealth.org

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • Lifestyle Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-08-26.