Virtual Housecalls: Redesigning Pediatric Primary Care Adolescent Obesity Treatment
Recruiting · NCT07246603 · Interventional (participants receive a specific treatment) · Lead sponsor: Virginia Commonwealth University
View the official record on ClinicalTrials.gov →Interventions studied
Virtual Housecalls
What this trial is 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.
Who can take part
Age range
12 Years to 15 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Children's Hospital of Richmond at VCU Healthy Lifestyles Center - Henrico, Virginia, United States