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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK136623-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurofeedback | Experimental | Three imaging (fMRI) sessions of experimental feedback. |
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| Control neurofeedback | Sham Comparator | Three imaging (fMRI) sessions of sham feedback. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental feedback | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathleen A Garrison, PhD | Contact | 2037376232 | kathleen.garrison@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kathleen A Garrison, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale MRRC Anlyan Center | Recruiting | New Haven | Connecticut | 06519 | United States |
Data will be findable for the research community through OpenNeuro and NITRC search functions.
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The research community will have access to data when the award ends.
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Control feedback | Device | 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). |
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| Week 1 and 3 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |