Virtual Housecalls: Redesigning Pediatric Primary Care Adolescent Obesity Treatment

NCT07246603 | Not Yet Recruiting DMC

• 2 other identifiers: HM300000084R01DK144911
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Keywords

Lifestyle Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Body Mass Index (BMI) Maintenance

  6 - 12 months

• Energy Intake

  0-6-months, 6-12-months

• Diet Quality

  0-6-months, 6-12-months

• Physical Activity

  0-6-months, 6-12-months

• Treatment Dose

  0-6-months

Study Arms (2)

Virtual Housecalls Intervention (VHC)

EXPERIMENTAL

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

Enhanced Treatment as Usual (TAU+)

NO 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.

Interventions

Virtual Housecalls BEHAVIORAL

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

Virtual Housecalls Intervention (VHC)

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• English or Spanish-speaking
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Henrico, Virginia, 23239, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Melanie K Bean, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

• Shari Barkin, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah M Farthing, MS

CONTACT

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

Melanie K Bean, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessors and MPIs will be masked to treatment group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)