Clinical trial NCT06969235: Examining the Role of Executive Functioning in Family-Based Intensive Health Behavior and Lifestyle Treatment
Official title: Examining the Role of Executive Functioning in Family-Based Intensive Health Behavior and Lifestyle Treatment to Address Pediatric Obesity (Healthy LIFT Groups)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Overweight
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 10
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Youth EF - CPT-3 Commissions
timeFrame: Post-Treatment (Month 6)
measure: Youth EF - Stroop
timeFrame: Post-Treatment (Month 6)
measure: Youth EF - Trails B
timeFrame: Post-Treatment (Month 6)
measure: Youth EF - BRIEF-2 Self Report GEC
timeFrame: Post-Treatment (Month 6)
measure: Youth EF - BRIEF-2 Parent Report GEC
timeFrame: Post-Treatment (Month 6)
Secondary outcomes:
measure: Youth Weight Status
timeFrame: Post-Treatment (Month 6)
measure: Youth Dietary Intake
timeFrame: Post-Treatment (Month 6)
measure: Youth Physical Activity
timeFrame: Post-Treatment (Month 6)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: College of Health Sciences, University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Crystal Lim, PhD, ABPP
role: PRINCIPAL_INVESTIGATOR
References: