Virtual Housecalls: Redesigning Pediatric Primary Care Adolescent Obesity Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-15
SponsorVirginia Commonwealth University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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%
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Housecalls
Behavioral26 contact hours of evidence-based intensive health and behavioral lifestyle treatment, as per the American Academy of Pediatrics Clinical Practice Guidelines
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Virtual Housecalls Intervention (VHC)Experimental treatment 1 intervention
Group B: Enhanced Treatment as Usual (TAU+)No intervention 0 interventions
Trial outcomes
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.
Time frame
0 - 6 monthsSecondary outcomes
1
Body Mass Index (BMI) Maintenance
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.
Time frame
6 - 12 months2
Energy Intake
Dietary intake (kilocalories/day); total of 1, 24-hour recall per assessment time point. Recalls will be obtained using the Automated Self-Administered 24-hour (ASA-24) dietary assessment tool with the assistance of trained staff who are masked to treatment assignment. Assessment time points include baseline (0), 6-month, and 12-months.
Time frame
0-6-months, 6-12-months3
Diet Quality
The Healthy Eating Index (HEI) will be used to measure diet quality using 1, 24-hour recall per assessment time point. Recalls will be obtained using the Automated Self-Administered 24-hour (ASA-24) dietary assessment tool with the assistance of trained staff who are masked to treatment assignment. HEI scores will be calculated from the ASA-24 recall data. Assessment time points include baseline (0), 6-month, and 12-months.
Time frame
0-6-months, 6-12-months4
Physical Activity
The Physical Activity Questionnaire for Adolescents (PAQ-A) will assess changes in time spent participating in moderate to vigorous physical activity (MVPA).
Time frame
0-6-months, 6-12-monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Virginia Commonwealth University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov