Examining the Role of Executive Functioning in Family-Based Intensive Health Behavior and Lifestyle Treatment

NCT06969235 | Recruiting

• 1 other identifier: 2122709
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Overweight

Outcome Measures

Primary Outcomes (5)

• 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)

  Post-Treatment (Month 6)

• 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)

  Post-Treatment (Month 6)

• Youth EF - Trails B

  Youth Trails B z-score; z-score (Mean = 0, SD = 1), with lower scores indicating worse executive functioning (EF)

  Post-Treatment (Month 6)

• 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)

  Post-Treatment (Month 6)

• Youth EF - BRIEF-2 Parent Report GEC

  Parent-report of youth Global Executive Composite (GEC) subscale T-score on the Behavior Rating Inventory of Executive Function Second Edition (BRIEF-2); T-score (Mean = 50, SD = 10), with higher scores representing worse executive functioning (EF)

  Post-Treatment (Month 6)

Secondary Outcomes (3)

• Youth Weight Status

  Post-Treatment (Month 6)

• Youth Dietary Intake

  Post-Treatment (Month 6)

• Youth Physical Activity

  Post-Treatment (Month 6)

Study Arms (1)

IHLBT

EXPERIMENTAL

intensive health behavior and lifestlye treatment

Behavioral: intensive health behavior and lifestyle treatment

Interventions

intensive health behavior and lifestyle treatment BEHAVIORAL

the 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.

IHLBT

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Participating youth and caregiver agree to attend IHBLT group meetings in-between the pre- and post-treatment assessments.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

College of Health Sciences, University of Missouri

Columbia, Missouri, 65211, United States

RECRUITING

Study Officials

• Crystal Lim, PhD, ABPP

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair and Associate Professor

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 13, 2025
• Study Start: May 5, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)