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PBT-EF for Obesity and ADHD (FRESH-EF Trial)
FRESH-EF Trial Summary
This trial will help researchers develop a better treatment program for children who are overweight or obese and have ADHD.
- Attention Deficit Hyperactivity Disorder (ADHD)
- Obesity
FRESH-EF Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FRESH-EF Trial Design
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Who is running the clinical trial?
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- Children with ADHD are not eligible to participate.The child has a BMI (body mass index) that puts them in the 85-99.9 percentile for their age and is considered overweight or obese.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.You have changed your medication for mental or attention issues within the past three months, and it may impact your weight or ADHD symptoms.
- Group 1: Executive Function-Enhanced Parent-Based Behavioral Treatment (PBT-EF)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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