NCT06426693

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Nov 2024Mar 2027

First Submitted

Initial submission to the registry

May 17, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 23, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

November 27, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

December 3, 2025

Status Verified

December 1, 2025

Enrollment Period

2.3 years

First QC Date

May 17, 2024

Last Update Submit

December 2, 2025

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (6)

  • Change in craving network strength during transfer runs

    Craving network strength will be measured during transfer (i.e., no feedback) runs and compared across scan sessions.

    Week 1 and 3

  • Change in Food Craving Inventory Mean Score

    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.

    Week 1, Week 7

  • Change in Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool Healthy Eating Index (HEI).

    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.

    Week 1, Week 7

  • Change in craving network strength during resting state runs

    Craving network strength will be measured during resting state runs and compared across scan sessions.

    Week 1 and 3

  • Change in Food Rating Task healthiness, tastiness, and choice scores

    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.

    Week 1, Week 7

  • Change in Food Snack Task caloric intake

    Food Snack Task will be used to measure caloric intake (out of a maximum value to calories offered) and compared across scan sessions.

    Week 1 and 3

Study Arms (2)

Neurofeedback

EXPERIMENTAL

Three imaging (fMRI) sessions of experimental feedback.

Device: Experimental feedback

Control neurofeedback

SHAM COMPARATOR

Three imaging (fMRI) sessions of sham feedback.

Device: Control feedback

Interventions

Experimental feedbackDEVICE

Participants provided with feedback of target brain activation patterns (e.g., thermometer) and will be instructed to try to change the feedback (e.g., decrease the thermometer).

Neurofeedback
Control feedbackDEVICE

Participants provided with control (sham, yoked to another participant) feedback (e.g., thermometer) and will be instructed to try to change the feedback (e.g., decrease the thermometer).

Control neurofeedback

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Current or past 6 months 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale MRRC Anlyan Center

New Haven, Connecticut, 06519, United States

RECRUITING

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kathleen A Garrison, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen A Garrison, PhD

CONTACT

2037376232kathleen.garrison@yale.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2024

First Posted

May 23, 2024

Study Start

November 27, 2024

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

December 3, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Data will be findable for the research community through OpenNeuro and NITRC search functions.

Time Frame
The research community will have access to data when the award ends.

Locations

US(1)