About this trial
The objectives of this open trial feasibility study are to examine the impacts of intensive health behavior and lifestyle treatment (IHBLT) on youth and caregiver executive functioning (EF), weight status, health behaviors (dietary intake, disordered eating, physical activity), and psychological functioning. Investigators propose to enroll 10 youth 13 to 17 years of age who have overweight or obesity (OV/OB) and a primary caregiver. Families will receive six months of evidence-based family focused group IHBLT based on social, cognitive, and family systems theories. Families will complete assessments of EF skills (objective and self-report), weight status, dietary intake, physical activity, and psychological functioning at pre- and post-treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Youth 13-17 years old
Youth with OV/OB (BMI≥85th percentile for age/gender norms)
Participating caregiver must be the participating youth's legal guardian
Participating youth and caregiver speak and read English
Disqualifiers
Youth pervasive developmental disorder (e.g., intellectual disability)
Youth or caregiver in commercial weight loss program or taking prescribed medications for the prior three months that impact appetite or weight
Youth or caregiver with documented history of eating disorder or untreated severe depression
Both youth and caregiver scores are two standard deviations or above the mean on the CPT-3 Commissions and Stroop Interference, representing significantly higher than average EF skills.
Trial design
Single group
Treatments tested in this trial
intensive health behavior and lifestyle treatment
Behavioralthe IHLBT will consist of 18 group meetings over 6 months that teens and parents attend. Topics covered during the meetings will include discussions regarding nutrition and physical activity recommendations, family communication, and use of strategies like monitoring, planning, goal setting, and problem solving.
Treatment groups
Trial outcomes
Primary outcomes
Youth EF - CPT-3 Commissions
Youth T-score on the Continuous Performance Test Third Edition (CPT-3) Commissions subscale; T-scores (M = 50, SD = 10) used with higher scores representing worse executive functioning (EF)
Youth EF - Stroop
Youth T-score on the Stroop Color Word Interference scale; T-scores (Mean = 50, SD = 10) used, with higher scores indicating better executive functioning (EF)
Youth EF - Trails B
Youth Trails B z-score; z-score (Mean = 0, SD = 1), with lower scores indicating worse executive functioning (EF)
Youth EF - BRIEF-2 Self Report GEC
Youth self-report on the Behavior Rating Inventory of Executive Function Second Edition (BRIEF-2) Global Executive Composite (GEC) subscale T-score; T-score (Mean = 50, SD = 10), with higher scores representing worse executive functioning (EF)
Secondary outcomes
Youth Weight Status
Youth body mass index (BMI) BMI z-score calculated based on height and weight measurements; z-scores have Mean = 0 and SD = 1; higher scores indicate higher weight status
Youth Dietary Intake
Youth Total kcals from 24 hour dietary recall
Youth Physical Activity
Youth time spent in moderate/vigorous physical activity on BLOCK screener
Sponsors and contacts
Click on the lead sponsor to view all of their trials.