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

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

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05165511
Acronym
FRESH-EF
Enrollment
0
Registered
2021-12-21
Start date
2022-07-26
Completion date
2025-05-01
Last updated
2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention-Deficit Hyperactivity Disorder, Overweight and Obesity

Keywords

weight loss, executive function, parent-based 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.

Interventions

BEHAVIORALPBT-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.

Sponsors

University of California, San Diego
Lead SponsorOTHER
Rady Children's Hospital, San Diego
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This is an open-label one-arm pilot study.

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Feasibility as measured by number of treatment sessions attendedOver the course of 5 months of treatmentAttendance at Treatment Sessions
AcceptabilityAt 5 monthsRatings of usefulness of treatment

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDawn M Eichen, PhD

University of California, San Diego

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026