- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07592728
Brief Inhibitory Training for Eating - Intervention (BITE-I)
Inhibitory Control Training for Adolescents
The purpose of this study is to conduct a proof-of-concept intervention of daily inhibitory control (IC) training.
Aim 1 is to examine the feasibility, acceptability, and barriers of an IC training EMI in adolescents' daily life.
Aim 2 is to evaluate the efficacy of IC training for modifying the hypothesized intervention mechanism: food-related IC and eating regulation.
In the study, participants will:
Complete questionnaires and cognitive tasks Receive a short nutrition education Complete three weeks of daily brain games on your phone
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tyler Mason, PhD
- Phone Number: 703-993-1000
- Email: tmason24@gmu.edu
Study Locations
-
-
Virginia
-
Fairfax, Virginia, United States, 22030
- Recruiting
- George Mason University
-
Contact:
- Tyler Mason
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 14-17 years old
- Have overweight or obesity (BMI-z≥85th percentile)
- Have a smartphone
- Can read and speak English
- Interest in improving one's diet.
Exclusion Criteria:
- Not currently in eating disorder or weight loss treatment or receiving pharmacological/surgical treatment for obesity in the past four weeks
- Not meeting criteria for atypical anorexia nervosa or bulimia nervosa
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Inhibitory control training
|
Children will first complete a short nutrition education then complete daily 10-minute inhibitroy control training each day for 10 minutes across 3 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inhibitory control
Time Frame: 1 month
|
Go-No/Go Task with food cues
|
1 month
|
|
Eating self-regulation
Time Frame: 1 month
|
Self-Regulation of Eating Behaviour Questionnaire
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Binge-eating symptoms
Time Frame: 1 month
|
Eating Pathology Symptom Inventory
|
1 month
|
|
Diet Quality
Time Frame: 1 month
|
Mini-EAT
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tyler Mason, PhD, George Mason University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00001112
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Overweight and/or Obesity
-
PfizerRecruitingObesity | Overnutrition | Nutrition Disorders | Overweight | Body Weight | Overweight or Obesity | Overweight and/or Obesity | Nutritional and Metabolic DiseasesUnited States, Canada
-
National University Health System, SingaporeActive, not recruitingObesity | Overweight and/or Obesity | Overweight or Obese Adults | Overweight , ObesitySingapore
-
Terrestrial Bio, Inc.CelerionRecruitingOverweight and/or ObesityUnited States
-
Carmen Lucas AbellánUniversidad Católica San Antonio de MurciaCompletedOverweight/Obesity | Overweight or Obese | Overweight or Obese Adults | Obesity and Overweight | Obese SubjectsSpain
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Universidad Pablo de OlavideUniversity of SevilleCompletedObesity | Overweight and Obesity | Overweight or ObesitySpain
-
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Recruiting
-
Universidad Católica San Antonio de MurciaEnrolling by invitationObesity | Overweight or ObesitySpain
-
Innovent Biologics (Suzhou) Co. Ltd.Completed
-
Hebei Medical University Third HospitalWestlake UniversityActive, not recruiting
Clinical Trials on Daily inhibitory control training
-
Boston Children's HospitalNeuroscouting, L.L.C.CompletedAttention Deficit Hyperactivity DisorderUnited States
-
King's College LondonUniversity of ExeterCompleted
-
Drexel UniversityDrexel Coulter Translational Research Partnership ProgramCompletedBinge Eating | Inhibition (Psychology)United States
-
Brigham Young UniversityCompletedOverweight and ObesityUnited States
-
Raquel Vilar LópezGovernment of SpainRecruitingOverweight and Obesity | Inhibition, PsychologicalSpain
-
University of Nevada, RenoNot yet recruitingHealthy AgingUnited States
-
Na LiuNot yet recruiting
-
University of KentuckyNational Institute on Drug Abuse (NIDA)CompletedCocaine Use DisorderUnited States
-
University of California, San DiegoEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed