- 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
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