Overweight or ObesityNCT06426693
Craving Network Neurofeedback
A study testing Experimental feedback in people with Overweight or Obesity, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- Experimental feedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18 to 60 years
- Body mass index >25 kg/m2
- >2.37 Food Craving Inventory score
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale MRRC Anlyan Center
New Haven, Connecticut, 06519
About this study
Official title: Connectome-based Neurofeedback of the Craving Network to Reduce Food Cue Reactivity
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.
Read the 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.
- Conditions
- Overweight or Obesity
- Being tested
- Experimental feedback, Control feedback
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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).
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback | Experimental | Three imaging (fMRI) sessions of experimental feedback. Receives: Device: Experimental feedback |
| Control neurofeedback | Sham comparator | Three imaging (fMRI) sessions of sham feedback. Receives: Device: Control feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 1 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start27 Nov 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen A Garrison, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426693
- Sponsor's protocol ID
- 2000037084
- Other IDs
- 1R01DK136623-01A1
- Status last verified
- Dec 2025
- First submitted
- 17 May 2024
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be findable for the research community through OpenNeuro and NITRC search functions.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connectome-based Neurofeedback of the Craving Network to Reduce Food Cue Reactivity
- ClinicalTrials.gov ID
- NCT06426693
- Acronym / sponsor ID
- 2000037084
- Conditions
- Overweight or Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback | Experimental | Device: Experimental feedbackThree imaging (fMRI) sessions of experimental feedback. |
| Control neurofeedback | Sham comparator | Device: Control feedbackThree imaging (fMRI) sessions of sham feedback. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ages 18 to 60 years
- Body mass index >25 kg/m2
- >2.37 Food Craving Inventory score
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental feedbackParticipants 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). | Device | Neurofeedback |
| Control feedbackParticipants 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). | Device | Control neurofeedback |
Primary outcome
Change in craving network strength during transfer runs
Time frame: 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
Time frame: 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 Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool Healthy Eating Index (HEI).
Time frame: 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.
Change in craving network strength during resting state runs
Time frame: Week 1 and 3
Craving network strength will be measured during resting state runs and compared across scan sessions.
Change in Food Rating Task healthiness, tastiness, and choice scores
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: Yes. Data will be findable for the research community through OpenNeuro and NITRC search functions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathleen A Garrison, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental feedback in people with Overweight or Obesity, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathleen A Garrison, PhD (2037376232, kathleen.garrison@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in craving network strength during transfer runs (time frame: Week 1 and 3). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.