Families, Responsibility, Education, Support, and Health for Executive Function

Not Applicable

Recruiting

• Conditions: Overweight and Obesity; Attention-Deficit Hyperactivity Disorder
• Interventions: Behavioral: PBT-EF

• Registration Number: NCT05165511
• Lead Sponsor: University of California, San Diego

Brief Summary

The pilot study will be a one group open-label treatment program and will be used to refine a parent-based behavioral treatment enhanced with executive-function training (PBT-EF) for children with comorbid overweight or obesity and Attention-Deficit Hyperactivity Disorder (ADHD).

Detailed Description

The currently recommended treatment for children with overweight or obesity (OW/OB), family-based behavioral treatment (FBT), results in sustained weight loss for only 1/3 of children. Attention-Deficit Hyperactivity Disorder (ADHD) is one of the most common neurobehavioral disorders in children and is characterized by difficulties in Executive Function (EF). Substantial research suggests higher rates of OW/OB in children with ADHD; thus, children with OW/OB and ADHD are likely to have greater difficulties with EF and achieving success in FBT. The proposed study aims to develop a parent-based behavioral treatment enhanced with EF training (PBT-EF) to improve treatment outcomes for children with comorbid OW/OB and ADHD. The treatment will be administered to parents in 18 group sessions over 5 months. Parents and children will be assessed at baseline, post-treatment, and 3-month follow-up. Assessments will include body mass index (BMI), assessments of executive function, and behavioral questionnaires. This study could provide a novel model to treat OW/OB in children with ADHD, and could inform clinical decision making regarding obesity treatment.

Study Timeline

• Study First Submitted: 2021-12-07
• Study First Submitted QC: 2021-12-07
• Study First Posted: 2021-12-21
• Study Start: 2022-07-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Child with overweight or obesity (85-99.9% BMI for age),
• Child age 8-12,
• Child with a diagnosis of ADHD,
• A parent willing to participate who can read and understand English at a minimum of a fifth-grade level, able to attend treatment sessions remotely via Zoom on video.

Exclusion Criteria

• Current enrollment in an organized weight control program (parent and child)
• Medication specifically prescribed for weight loss (child)
• Medical or psychiatric condition that may interfere with treatment participation or that may require physician monitoring of diet and/or exercise (e.g., acute suicidality; psychosis; substance use disorder) (parent and child)
• Change in psychotropic medication or other medication that may impact weight or ADHD symptoms during the previous 3 months (child)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Executive Function-Enhanced Parent-Based Behavioral Treatment (PBT-EF)	PBT-EF	PBT-EF will integrate executive function training with family-based behavioral treatment (FBT) for obesity, the gold-standard behavioral treatment for childhood obesity. PBT-EF will include self-monitoring, calorie reduction, and dietary and physical activity recommendations in addition to planning, organization, and problem-solving skills.

Primary Outcome Measures

Name	Time	Method
Feasibility as measured by number of treatment sessions attended	Over the course of 5 months of treatment	Attendance at Treatment Sessions
Acceptability	At 5 months	Ratings of usefulness of treatment

Trial Locations

Locations (1)

UCSD Center for Healthy Eating and Activity Research (CHEAR); 🇺🇸 San Diego, California, United States