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Clinical Trials/NCT05165511
NCT05165511
Withdrawn
Not Applicable

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

University of California, San Diego1 site in 1 country30 target enrollmentJuly 26, 2022

Overview

Phase
Not Applicable
Intervention
PBT-EF
Conditions
Overweight and Obesity
Sponsor
University of California, San Diego
Enrollment
30
Locations
1
Primary Endpoint
Feasibility as measured by number of treatment sessions attended
Status
Withdrawn
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 26, 2022
End Date
May 1, 2025
Last Updated
last month
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dawn Eichen

Assistant Professor

University of California, San Diego

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)

Arms & Interventions

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.

Intervention: PBT-EF

Outcomes

Primary Outcomes

Feasibility as measured by number of treatment sessions attended

Time Frame: Over the course of 5 months of treatment

Attendance at Treatment Sessions

Acceptability

Time Frame: At 5 months

Ratings of usefulness of treatment

Study Sites (1)

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