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

NCT05165511 | Withdrawn

• 1 other identifier: 210123
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Overweight and Obesity; Attention-Deficit Hyperactivity Disorder

Keywords

weight loss; executive function; parent-based treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Child body mass index (BMI)

  Change from baseline at an average of 5 months and 8 months

• Child executive function

  Change from baseline at an average of 5 months and 8 months

• Parent executive function

  Change from baseline at an average of 5 months and 8 months

Study Arms (1)

Executive Function-Enhanced Parent-Based Behavioral Treatment (PBT-EF)

EXPERIMENTAL

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

Interventions

PBT-EF 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.

Executive Function-Enhanced Parent-Based Behavioral Treatment (PBT-EF)

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Diego: lead
• Rady Children's Hospital, San Diego: collaborator

Study Sites (1)

UCSD Center for Healthy Eating and Activity Research (CHEAR)

San Diego, California, 92037, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Attention Deficit Disorder with Hyperactivity; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Body Weight Changes

Study Officials

• Dawn M Eichen, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is an open-label one-arm pilot study.

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 21, 2021
• Study Start: July 26, 2022
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 4, 2026

Record last verified: 2025-03

Locations

US (1)