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

Virginia Commonwealth University (VCU)

Status: Begins enrollment in 5 months

Conditions: Pediatric Obesity; Class I Obesity

Treatments: Behavioral: Virtual Housecalls

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07246603

R01DK144911 (U.S. NIH Grant/Contract)

HM300000084

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 12 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

Virtual Housecalls Intervention (VHC)

Experimental group

Description:

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.

Treatment:

Behavioral: Virtual Housecalls

Enhanced Treatment as Usual (TAU+)

No Intervention group

Description:

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.