Clinical trial

Virtual Housecalls: Redesigning Pediatric Primary Care Adolescent Obesity Treatment

Recruiting now · Not applicable · 1 countries · Registry ID NCT07246603

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age12 Years to 15 Years
SexAll
Healthy volunteersAccepted
ConditionClass I Obesity, Pediatric Obesity

Full registry 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

Treatments and study arms

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

Primary outcomes

Body Mass Index (BMI) Change0 - 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Children's Hospital of Richmond at VCU Healthy Lifestyles Center🇺🇸 Henrico, Virginia, United States
Sarah M Farthing, MSContact
Melanie K Bean, Ph.D.Contact