Families, Responsibility, Education, Support, and Health for Executive Function (FRESH-EF)

Executive Function Enhanced Parent-Based Treatment for Children With ADHD and Overweight or Obesity

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).

Study Overview

• Status: Withdrawn
• Conditions: Overweight and Obesity; Attention-Deficit Hyperactivity Disorder
• Intervention / Treatment: Behavioral: PBT-EF

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92037
      • UCSD Center for Healthy Eating and Activity Research (CHEAR)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Executive Function-Enhanced Parent-Based Behavioral Treatment (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.

Behavioral: PBT-EF; PBT-EF will be delivered to parents only. Parents will be taught general behavioral weight loss skills to apply to their child and themselves including decreasing caloric intake and increasing physical activity, self-monitoring, and goal setting. Additionally, parents will learn compensatory strategies surrounding organization, habit learning, planning, and problem-solving to generalize FBT skills to real-world behaviors (e.g., self-monitoring of food intake). Each session will include interactive exercises to help train an aspect of EF. Skills taught will be presented to be practiced with real-world applications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility as measured by number of treatment sessions attended	Attendance at Treatment Sessions	Over the course of 5 months of treatment
Acceptability	Ratings of usefulness of treatment	At 5 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child body mass index (BMI)	As measured by height and weight (kg/m^2)	Change from baseline at an average of 5 months and 8 months
Child executive function	Change in executive function measured by Behavior Rating in Executive Functioning - 2 (BRIEF-2). The Global Executive Composite score reflects a standardized t-score with higher scores reflecting greater difficulties in executive function.	Change from baseline at an average of 5 months and 8 months
Parent executive function	Change in executive function measured by Behavior Rating in Executive Functioning - Adult (BRIEF-A). The Global Executive Composite score reflects a standardized t-score with higher scores reflecting greater difficulties in executive function.	Change from baseline at an average of 5 months and 8 months
Child behavioral symptoms - Child Behavior Checklist (CBCL)	Change in child behavioral symptoms rated by parents as measured by CBCL. The CBCL is a widely used parent-report questionnaire designed to assess behavioral problems and social competencies of children ages 4-18. It yields standardized T scores and age adjusted scores on internalizing, externalizing, and total behavior difficulties. Higher scores reflect greater behavioral difficulties.	Change from baseline at an average of 5 months and 8 months
Child behavioral symptoms - Vanderbilt ADHD [Attention Deficit Hyperactivity Disorder] Parent Rating Scale	Change in child behavioral symptoms rated by parents as measured by Vanderbilt ADHD Parent Rating Scale. This scale is a parent-report questionnaire. The parent rates the frequency of 47 behaviors that may indicate behavioral issues. There are also 8 performance questions. Change in total symptoms of the 18 ADHD criteria will be reported. Higher scores reflect greater ADHD symptomatology.	Change from baseline at an average of 5 months and 8 months

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: Rady Children's Hospital, San Diego
• Investigators: Principal Investigator: Dawn M Eichen, PhD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2022
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: weight loss; executive function; parent-based treatment
• Additional Relevant MeSH Terms: Mental Disorders; Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Weight Loss; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 210123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No