Recruiting

Observational Study

Sponsor:

University of Missouri-Columbia

Code:

NCT06969235

Conditions

Pediatric Overweight

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Interventions

intensive health behavior and lifestyle treatment

Study Details

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 ID

NCT06969235

Start date

May 5, 2025

Status verified date

Feb, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IHLBT

intensive health behavior and lifestlye treatment

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.

Primary outcome measure

  • Youth EF - CPT-3 Commissions [ Time Frame: Post-Treatment (Month 6) ]
  • Youth EF - Stroop [ Time Frame: Post-Treatment (Month 6) ]
  • Youth EF - Trails B [ Time Frame: Post-Treatment (Month 6) ]
  • Youth EF - BRIEF-2 Self Report GEC [ Time Frame: Post-Treatment (Month 6) ]
  • Youth EF - BRIEF-2 Parent Report GEC [ Time Frame: Post-Treatment (Month 6) ]

Central Contacts and Locations

Locations

College of Health Sciences, University of Missouri

Recruiting

Columbia, Missouri, United States, 65211

Contacts

Crystal Lim, PhD, ABPP

573-882-2667limcs@health.missouri.edu

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2026-02-12.