Families, Responsibility, Education, Support, and Health for Executive Function (FRESH-EF)
Primary Purpose
Overweight and Obesity, Attention-Deficit Hyperactivity Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PBT-EF
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity focused on measuring weight loss, executive function, parent-based treatment
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)
Sites / Locations
- UCSD Center for Healthy Eating and Activity Research (CHEAR)Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Executive Function-Enhanced Parent-Based Behavioral Treatment (PBT-EF)
Arm Description
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.
Outcomes
Primary Outcome Measures
Feasibility as measured by number of treatment sessions attended
Attendance at Treatment Sessions
Acceptability
Ratings of usefulness of treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT05165511
First Posted
December 7, 2021
Last Updated
September 1, 2022
Sponsor
University of California, San Diego
Collaborators
Rady Children's Hospital, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT05165511
Brief Title
Families, Responsibility, Education, Support, and Health for Executive Function
Acronym
FRESH-EF
Official Title
Executive Function Enhanced Parent-Based Treatment for Children With ADHD and Overweight or Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Rady Children's Hospital, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Attention-Deficit Hyperactivity Disorder
Keywords
weight loss, executive function, parent-based treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is an open-label one-arm pilot study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Executive Function-Enhanced Parent-Based Behavioral Treatment (PBT-EF)
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
PBT-EF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility as measured by number of treatment sessions attended
Description
Attendance at Treatment Sessions
Time Frame
Over the course of 5 months of treatment
Title
Acceptability
Description
Ratings of usefulness of treatment
Time Frame
At 5 months
Other Pre-specified Outcome Measures:
Title
Child body mass index (BMI)
Description
As measured by height and weight (kg/m^2)
Time Frame
Change from baseline at an average of 5 months and 8 months
Title
Child executive function
Description
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.
Time Frame
Change from baseline at an average of 5 months and 8 months
Title
Parent executive function
Description
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.
Time Frame
Change from baseline at an average of 5 months and 8 months
Title
Child behavioral symptoms - Child Behavior Checklist (CBCL)
Description
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.
Time Frame
Change from baseline at an average of 5 months and 8 months
Title
Child behavioral symptoms - Vanderbilt ADHD [Attention Deficit Hyperactivity Disorder] Parent Rating Scale
Description
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.
Time Frame
Change from baseline at an average of 5 months and 8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allison S Tietz, BS
Phone
(858)380-5579
Email
astietz@health.ucsd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dawn M Eichen, PhD
Phone
(858)534-8322
Email
deichen@ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn M Eichen, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Center for Healthy Eating and Activity Research (CHEAR)
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison S Tietz, BS
Phone
858-380-5579
Email
astietz@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Dawn M Eichen, PhD
Phone
858-534-8322
Email
deichen@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Dawn M Eichen, PhD
12. IPD Sharing Statement
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Families, Responsibility, Education, Support, and Health for Executive Function
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