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Recruiting NCT06969235

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

No phase Interventional Pediatric Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: intensive health behavior and lifestyle treatment.
Who it may be relevant to
Registry conditions: Pediatric Overweight. Basic parameters: 13 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Examining the Role of Executive Functioning in Family-Based Intensive Health Behavior and Lifestyle Treatment to Address Pediatric Obesity (Healthy LIFT Groups)

Overview

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.

Interventions

  • Behavioral 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 measures

  • 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)]
Secondary outcome measures (3)
  • Youth Weight Status [Time frame: Post-Treatment (Month 6)]
  • Youth Dietary Intake [Time frame: Post-Treatment (Month 6)]
  • Youth Physical Activity [Time frame: Post-Treatment (Month 6)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • College of Health Sciences, University of Missouri — Columbia

Identifiers

NCT: NCT06969235 · 2122709

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗