Clinical trial NCT05165511: Families, Responsibility, Education, Support, and Health for Executive Function
Official title: Executive Function Enhanced Parent-Based Treatment for Children With ADHD and Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Attention-Deficit Hyperactivity Disorder
Keywords: weight loss
executive function
parent-based treatment
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Rady Children's Hospital, San Diego
First posted: 2021-12-21
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open-label one-arm pilot study.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Feasibility as measured by number of treatment sessions attended
timeFrame: Over the course of 5 months of treatment
measure: Acceptability
timeFrame: At 5 months
Secondary outcomes:
Other outcomes:
measure: Child body mass index (BMI)
timeFrame: Change from baseline at an average of 5 months and 8 months
measure: Child executive function
timeFrame: Change from baseline at an average of 5 months and 8 months
measure: Parent executive function
timeFrame: Change from baseline at an average of 5 months and 8 months
measure: Child behavioral symptoms - Child Behavior Checklist (CBCL)
timeFrame: Change from baseline at an average of 5 months and 8 months
measure: Child behavioral symptoms - Vanderbilt ADHD [Attention Deficit Hyperactivity Disorder] Parent Rating Scale
timeFrame: Change from baseline at an average of 5 months and 8 months
Locations:
city: San Diego
country: United States
facility: UCSD Center for Healthy Eating and Activity Research (CHEAR)
state: California
Study officials:
affiliation: University of California, San Diego
name: Dawn M Eichen, PhD
role: PRINCIPAL_INVESTIGATOR
References: