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Attention Bias Retraining for Obesity
Phase 2
Waitlist Available
Led By Jack A Yanovski, M.D.
Research Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
BMI at or above the 85th percentile for age and sex according to the Centers for Disease Control US Standards (101)
Age between 12 and 17 years (at the start of the study)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-weeks
Awards & highlights
Study Summary
This trial is studying the relationship between eating patterns, body weight, and how the brain reacts to different images in teens.
Who is the study for?
This trial is for right-handed, overweight female teens aged 12-17 with a BMI at or above the 85th percentile. It's not for those who are pregnant, use substances regularly, have had significant brain injuries, are in weight loss programs or psychotherapy for eating behavior, take medications affecting weight/eating (except on a case-by-case basis), have serious psychiatric disorders or major illnesses.Check my eligibility
What is being tested?
The study tests if training attention away from unhealthy foods using a smartphone program can affect eating patterns and body weight in teens. Participants will undergo various assessments including MRI scans and blood tests over six visits spanning approximately eight months.See study design
What are the potential side effects?
Since this trial involves non-invasive procedures like attention retraining via smartphone and standard medical assessments (MRI scan, blood draw), side effects may be minimal but could include discomfort from fasting before visits or anxiety during MRI scanning.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is in the top 15% for my age and sex.
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I am between 12 and 17 years old.
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I am female.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in laboratory measured attention bias
Neural activity during attention bias task
Secondary outcome measures
Change in attention bias
Change in eating pattern
Change in reaction time to palatable foods
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Booster TrainingExperimental Treatment1 Intervention
3 months after the randomized program is completed, each subject can elect to use open-label attention bias retraining for 2 weeks
Group II: AB RetrainingExperimental Treatment1 Intervention
Active treatment - the probe always replaces the neutral picture. There is a perfect correlation between picture type and probe location.
Group III: Booster Training - active comparatorActive Control1 Intervention
3 months after the randomized program is completed, each subject can elect to use open-label attention bias retraining for 2 weeks
Group IV: AB ControlPlacebo Group1 Intervention
Control condition - the probe is equally likely to replace the food picture and the neutral picture. There is no correlation between picture type and probe location, and no training of attention should occur.
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Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor
1,978 Previous Clinical Trials
2,680,803 Total Patients Enrolled
105 Trials studying Obesity
102,241 Patients Enrolled for Obesity
Jack A Yanovski, M.D.Principal InvestigatorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
23 Previous Clinical Trials
7,186 Total Patients Enrolled
14 Trials studying Obesity
3,827 Patients Enrolled for Obesity
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently in a program or therapy for weight loss or eating behavior.I have lost more than 5% of my weight in the last three months.You have not experienced any episodes of loss of control eating in the past month, as determined by a special interview with a doctor who specializes in eating disorders.You have experienced at least one episode of loss of control (LOC) eating in the past month, which means you felt like you couldn't control your eating. This will be assessed using a special interview for eating disorders.You regularly use substances like alcohol, tobacco, or e-cigarettes.I have not had a major brain injury or multiple concussions in the past year.I am fluent in English and can follow instructions and complete questionnaires in English.My BMI is in the top 15% for my age and sex.I am between 12 and 17 years old.You cannot undergo a test called MEG if you have metal in your body, are pregnant, have a fear of enclosed spaces, or have had a serious brain injury in the past.I do not have major illnesses like kidney, liver, stomach problems, or untreated thyroid issues.I use medication that can affect my weight or how I eat.I am female.I have a health issue related to obesity, like high blood pressure or diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Booster Training
- Group 2: AB Control
- Group 3: AB Retraining
- Group 4: Booster Training - active comparator
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
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