PBT-EF for Obesity and ADHD

(FRESH-EF Trial)

Overseen By Allison S Tietz, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Weight loss medications

Disqualifiers: Weight control program, Suicidality, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

Duration: 5 months

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that children should not have changed their psychotropic or other medications affecting weight or ADHD symptoms in the past 3 months.

What data supports the effectiveness of the treatment PBT-EF for obesity and ADHD?

Research suggests that treating ADHD in individuals with obesity can improve weight management strategies, indicating that addressing ADHD symptoms may help with weight loss in those with both conditions. ^{1 2 3 4 5}

How is the treatment PBT-EF for obesity and ADHD different from other treatments?

PBT-EF may be unique in addressing both obesity and ADHD by potentially targeting excessive daytime sleepiness, which is linked to both conditions. This dual approach could offer a novel way to manage symptoms of ADHD while also promoting weight loss. ^{1 2 6 7 8}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Parents receive the PBT-EF treatment in 18 group sessions over 5 months, integrating executive function training with family-based behavioral treatment for obesity.

5 months

18 group sessions

Follow-up

Participants are monitored for changes in BMI, executive function, and behavioral symptoms at 3 months post-treatment.

3 months

Treatment Details

Interventions

• PBT-EF

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+

Rady Children's Hospital, San Diego

Collaborator

Trials

42

Recruited

14,300+

References

1. England pubmed.ncbi.nlm.nih.gov

Treatment of refractory obesity in severely obese adults following management of newly diagnosed attention deficit hyperactivity disorder. [2009]

2. Norway pubmed.ncbi.nlm.nih.gov

High prevalence of attention-deficit/hyperactivity disorder in adolescents with severe obesity seeking bariatric surgery. [2021]

3. England pubmed.ncbi.nlm.nih.gov

The relationship between ADHD and obesity: implications for therapy. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Association between symptoms of attention-deficit/hyperactivity disorder and bulimic behaviors in a clinical sample of severely obese adolescents. [2009]

5. Germany pubmed.ncbi.nlm.nih.gov

Weight loss following a clinic-based weight loss program among adults with attention deficit/hyperactivity disorder symptoms. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Does excessive daytime sleepiness contribute to explaining the association between obesity and ADHD symptoms? [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Attention-Deficit/Hyperactivity Disorder and Obesity: A National Study of 1.1 Million Israeli Adolescents. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Obesity and Attention-Deficit Hyperactivity Disorder. [2022]