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

NCT ID: NCT06969235

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-05
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IHLBT

intensive health behavior and lifestlye treatment

Group Type: EXPERIMENTAL

intensive health behavior and lifestyle treatment

Intervention Type: 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.

Interventions

intensive health behavior and lifestyle treatment

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Crystal Lim

Chair and Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Crystal Lim, PhD, ABPP

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

College of Health Sciences, University of Missouri

Columbia, Missouri, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Crystal Lim, PhD, ABPP

Role: primary

limcs@health.missouri.edu

573-882-2667

Other Identifiers

2122709

Identifier Type: -

Identifier Source: org_study_id