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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help children who are both overweight and have ADHD. The treatment, called PBT-EF, combines family-based strategies for managing obesity, such as tracking food intake and exercise, with training to enhance skills like planning and organization. Children aged 8-12 diagnosed with ADHD and dealing with being overweight might be suitable candidates, especially if a parent can participate in online sessions. The goal is to refine this combined treatment to make it more effective for families. This trial focuses on improving a single method rather than comparing different treatments. As an unphased trial, it offers families a unique opportunity to contribute to innovative research that could enhance treatment options for children with ADHD and obesity.

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 prior data suggests that this protocol is safe for children with obesity and ADHD?

Research shows that treatments involving parental assistance in changing a child's behavior are generally well-received by children and their families. These treatments have proven effective in helping children with ADHD and managing obesity. The PBT-EF treatment combines these successful strategies with exercises to enhance skills like planning and problem-solving.

Specific safety data for PBT-EF is not yet available, but it is based on well-known methods that have not shown major side effects in past studies. Since PBT-EF focuses on behavior modification rather than medication, it is expected to be safe for children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PBT-EF for obesity and ADHD because it combines executive function training with the gold-standard family-based behavioral treatment (FBT) for childhood obesity. Unlike other treatments, which typically focus solely on calorie reduction and physical activity, PBT-EF adds planning, organization, and problem-solving skills to help families manage obesity and ADHD more effectively. This integrated approach aims to tackle the root behavioral challenges, potentially leading to more sustainable lifestyle changes and better long-term outcomes.

What evidence suggests that PBT-EF is effective for obesity and ADHD?

This trial will evaluate the Executive Function-Enhanced Parent-Based Behavioral Treatment (PBT-EF) for children with obesity and ADHD. Research has shown that treatments involving parents and enhanced with skills training can benefit children with these conditions. In one study, children who received such treatments experienced a noticeable drop in their BMI (body mass index) immediately after the program. Skills training focuses on improving planning, organization, and problem-solving, which often challenge these children. By combining this training with family-based support, the approach addresses both behavior and thinking skills. This combined method aims to improve the management of both conditions. ^{2 6 7 8 9}

Who Is on the Research Team?

Dawn M Eichen, PhD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05165511

Study Details | NCT05165511 | Families, Responsibility, ... The proposed study aims to develop a parent-based behavioral treatment enhanced with EF training (PBT-EF) to improve treatment outcomes for children with ...

2. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT05165511

UCSD Obesity Trial → Families, Responsibility, Education ... The proposed study aims to develop a parent-based behavioral treatment enhanced with EF training (PBT-EF) to improve treatment outcomes for ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5952537/

Effectiveness of Parents-Focused Cognitive-Behavioral ... The results of this study showed that BMIs of children who received the intervention significantly decreased immediately after the intervention ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1876201825001029

Internet-based behavioural parent training intervention for ... This study evaluates the efficacy of an 8-session internet-based BPT (I-BPT) program in improving ADHD symptoms and mental health outcomes for children and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5702584/

Executive Function in Childhood Obesity Children with obesity have well-documented deficits in EF, which may impede effectiveness of current, evidence-based treatments.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05165511

Families, Responsibility, Education, Support, and Health ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11162428/

Improving the efficacy and effectiveness of evidence-based ... Overall, commercialized BPT and homegrown BPT have been found to be effective in improving the functioning of children with ADHD and their ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1551714424001459

A randomized controlled trial examining general parenting ... This clinical trial tests the effect of parenting training on childhood obesity. Results will inform the development of more effective treatments.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12379403/

Parent training tailored for parents with ADHD: a randomized ... Improving Parenting Skills Adult ADHD (IPSA) is a new BPT program tailored to parents with ADHD. It was developed using an iterative co-creation ...