Craving Network Neurofeedback

Not Applicable

Recruiting

• Conditions: Overweight or Obesity
• Interventions: Device: Experimental feedback; Device: Control feedback

• Registration Number: NCT06426693
• Lead Sponsor: Yale University

Brief Summary

This project tests whether individuals with overweight or obesity and high craving can learn to change their brain response to food cues using neurofeedback, to impact their craving and eating behavior.

Detailed Description

Aim 1 of this study is to test whether neurofeedback from the craving network is associated with reduced craving network strength.

Aim 2 of this study is to test whether neurofeedback from the craving network is associated with reduced food craving and changes in eating behavior.

Aim 3 of this study is to test whether neurofeedback from the craving network is associated with changes in resting state functional connectivity.

Study Timeline

• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-17
• Study First Posted: 2024-05-23
• Study Start: 2024-11-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Ages 18 to 60 years
• Body mass index >25 kg/m2
• >2.37 Food Craving Inventory score

Exclusion Criteria

• Use of anti-obesity medications
• Weight-reduced state defined as >10% weight reduction in the past 6 months.
• Nicotine use
• Current diagnosis of neurological or psychiatric disorder
• Obesity-related diseases such as type-2 diabetes
• Contraindications to MRI
• Baseline scanning with motion >0.15mm frame to frame displacement.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neurofeedback	Experimental feedback	Three imaging (fMRI) sessions of experimental feedback.
Control neurofeedback	Control feedback	Three imaging (fMRI) sessions of sham feedback.

Primary Outcome Measures

Name	Time	Method
Change in Food Rating Task healthiness, tastiness, and choice scores	Week 1, Week 7	Food Rating Task outcomes include healthiness, tastiness, and choice. Healthiness and tastiness mean score is taken, range 1-5, with 5 indicating higher healthiness or tastiness. Choice is counted from 0-48 items choosing the food item over the neutral reference food item, with higher values indicating more frequent choice. Food Ratings will be compared between baseline and 1 month follow-up.
Change in Food Snack Task caloric intake	Week 1 and 3	Food Snack Task will be used to measure caloric intake (out of a maximum value to calories offered) and compared across scan sessions.
Change in craving network strength during transfer runs	Week 1 and 3	Craving network strength will be measured during transfer (i.e., no feedback) runs and compared across scan sessions.
Change in Food Craving Inventory Mean Score	Week 1, Week 7	Food Craving Inventory has 28 items rated 1-5 and overall mean is calculated, range 1-5 with higher score indicating higher craving. FCI will be compared between baseline and 1 month follow-up.
Change in craving network strength during resting state runs	Week 1 and 3	Craving network strength will be measured during resting state runs and compared across scan sessions.
Change in Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool Healthy Eating Index (HEI).	Week 1, Week 7	ASA-24 HEI is scored 0-100 with 100 indicating healthier diet and composite scores examined to interpret the overall score. HEI will be compared between baseline and 1 month follow-up.

Trial Locations

Locations (1)

Yale MRRC Anlyan Center; 🇺🇸 New Haven, Connecticut, United States