PBT-EF for Obesity and ADHD

(FRESH-EF Trial)

Overseen by Dawn M Eichen, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, San Diego

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new program that helps parents teach their overweight or obese children with ADHD how to manage their weight and improve their behavior. The program includes special training to help kids focus better and control their impulses. The goal is to make it easier for these children to stick to healthy habits. Parents focused CBT can be considered as a complementary treatment for reducing ADHD symptoms and BMI and increased self-esteem in the obese ADHD children.

Research Team

Dawn M Eichen, PhD

Principal Investigator

University of California, San Diego

Eligibility Criteria

This trial is for parents who can read and understand English at a fifth-grade level or higher, with children aged 8-12 diagnosed with ADHD and are overweight (85-99.9% BMI for age). They must be able to attend remote sessions via Zoom. Families already in weight control programs or using weight loss meds, and those with certain medical/psychiatric conditions cannot join.

Inclusion Criteria

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

Child age 8-12

Children with ADHD are not eligible to participate.

Exclusion Criteria

Current enrollment in an organized weight control program (parent and child)

Children who are taking medication for weight loss are not allowed to participate.

You have a medical or mental condition that could affect your ability to participate in the treatment or require close monitoring by a doctor, such as serious depression, drug addiction, or psychosis. This applies to both parents and children.

Treatment Details

Interventions

• PBT-EF (Behavioral Intervention)

Trial Overview The study tests a new treatment program called PBT-EF designed for children with both obesity and ADHD. It's an open-label pilot study where all participants receive the same intervention through remote sessions to improve parental support and child's executive function.

Participant Groups

Group I: Executive Function-Enhanced Parent-Based Behavioral Treatment (PBT-EF) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Dr. Christopher Longhurst

University of California, San Diego

Chief Medical Officer since 2021

MD and MS in Medical Informatics from UC Davis

Patty Maysent

University of California, San Diego

Chief Executive Officer since 2016

MBA from Stanford University

Rady Children's Hospital, San Diego

Collaborator

Trials

42

Recruited

14,300+