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

Overweight and Obesity Clinical Trial

— FRESH-EF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05165511
• Other study ID #: 210123
• Status: Recruiting
• Phase: N/A
• Start date: July 26, 2022
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of California, San Diego
• Contact: Allison S Tietz, BS
• Phone: (858)380-5579
• Email: astietz[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit Hyperactivity Disorder
• Obesity
• Overweight
• Overweight and Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	UCSD Center for Healthy Eating and Activity Research (CHEAR)	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Rady Children's Hospital, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	Feasibility as measured by number of treatment sessions attended	Attendance at Treatment Sessions	Over the course of 5 months of treatment
Primary	Acceptability	Ratings of usefulness of treatment	At 5 months