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Behavioral Intervention

PBT-EF for Obesity and ADHD (FRESH-EF Trial)

N/A

Recruiting

Led By Dawn M Eichen, PhD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline at an average of 5 months and 8 months

Awards & highlights

FRESH-EF Trial Summary

This trial will help researchers develop a better treatment program for children who are overweight or obese and have ADHD.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this is a behavioral treatment focusing on education and support without medication, no direct side effects like those from drugs are expected. However, stress or discomfort due to lifestyle changes may occur.

FRESH-EF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at an average of 5 months and 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline at an average of 5 months and 8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at an average of 5 months and 8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability

Feasibility as measured by number of treatment sessions attended

Other outcome measures

Child behavioral symptoms - Child Behavior Checklist (CBCL)

Child behavioral symptoms - Vanderbilt ADHD [Attention Deficit Hyperactivity Disorder] Parent Rating Scale

Child body mass index (BMI)

+2 more

FRESH-EF Trial Design

1Treatment groups

Experimental Treatment

Group I: Executive Function-Enhanced Parent-Based Behavioral Treatment (PBT-EF)Experimental Treatment1 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,129 Previous Clinical Trials

1,552,590 Total Patients Enrolled

1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)

144 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Rady Children's Hospital, San DiegoOTHER

39 Previous Clinical Trials

13,503 Total Patients Enrolled

Dawn M Eichen, PhDPrincipal InvestigatorUniversity of California, San Diego

1 Previous Clinical Trials

39 Total Patients Enrolled

Media Library

PBT-EF (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05165511 — N/A

Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Executive Function-Enhanced Parent-Based Behavioral Treatment (PBT-EF)

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: PBT-EF Highlights & Side Effects. Trial Name: NCT05165511 — N/A

PBT-EF (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05165511 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total amount of participants being enrolled in this research project?

"Yes, the information on clinicaltrials.gov confirms that recruitment for this medical study is active; it was originally posted on July 26th 2022 and last updated on September 1st 2022. The trial intends to enroll 30 patients from a single site."

Answered by AI

Who would be a qualified candidate to enroll in this medical trial?

"This research is seeking to enrol 30 minors between the ages of 8 and 12 with a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) alongside being overweight or obese. The precise Body Mass Index for each individual will be calculated relative to their age."

Answered by AI

Is this experiment still open to new participants?

"Affirmative. The information posted on clinicaltrials.gov indicates that this research is currently recruiting participants. Originally published on July 26th 2022, the trial has recruited 30 patients from a single location since its last update in September of the same year."

Answered by AI

Is the age criterion for enrollment in this trial flexible enough to include senior citizens?

"This medical research requires that the participant be between 8 and 12 years old. There are 330 studies for children younger than 18, and 733 studies for seniors over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Dawn Eichen 2022. "Families, Responsibility, Education, Support, and Health for Executive Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05165511.