NCT07246603 · Virginia Commonwealth University
Virtual Housecalls: Redesigning Pediatric Primary Care Adolescent Obesity Treatment
(VHC)
What this study is about
This pragmatic randomly assigned 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.
View original scientific description
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.
Interventions
BEHAVIORAL
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 measures
Body Mass Index (BMI) Change
Time frame: 0 - 6 months
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Henrico, Virginia
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 26, 2026 · Source of record for eligibility and locations