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

NCT ID: NCT05165511

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-26
• Study Completion Date: 2026-12-31

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.

Conditions

Overweight and Obesity; Attention-Deficit Hyperactivity Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PBT-EF

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rady Children's Hospital, San Diego

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Dawn Eichen

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dawn M Eichen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

UCSD Center for Healthy Eating and Activity Research (CHEAR)

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Allison S Tietz, BS

Role: CONTACT

astietz@health.ucsd.edu

(858)380-5579

Dawn M Eichen, PhD

Role: CONTACT

deichen@ucsd.edu

(858)534-8322

Facility Contacts

Allison S Tietz, BS

Role: primary

astietz@ucsd.edu

858-380-5579

Dawn M Eichen, PhD

Role: backup

deichen@ucsd.edu

858-534-8322

Other Identifiers

210123

Identifier Type: -

Identifier Source: org_study_id