## Protocol Section
### Identification Module
**NCT ID:** NCT06426693

**Brief Title:** Craving Network Neurofeedback

**Official Title:** Connectome-based Neurofeedback of the Craving Network to Reduce Food Cue Reactivity

#### Organization Study ID Info
**ID:** 2000037084
#### Organization
**Class:** OTHER
**Full Name:** Yale University
#### Secondary ID Infos
**ID:** 1R01DK136623-01A1
**Link:** https://reporter.nih.gov/quickSearch/1R01DK136623-01A1
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2027-03-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-03-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

#### Lead Sponsor

**Class:** OTHER

**Name:** Yale University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Overweight or Obesity

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Three imaging (fMRI) sessions of experimental feedback.

**Intervention Names:**

- Device: Experimental feedback

**Label:** Neurofeedback

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Three imaging (fMRI) sessions of sham feedback.

**Intervention Names:**

- Device: Control feedback

**Label:** Control neurofeedback

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Neurofeedback

**Description:** 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).

**Name:** Experimental feedback

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Control neurofeedback

**Description:** 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).

**Name:** Control feedback

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Change in craving network strength during transfer runs

**Time Frame:** Week 1 and 3

**Description:** 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.

**Measure:** Change in Food Craving Inventory Mean Score

**Time Frame:** Week 1, Week 7

**Description:** 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.

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

**Time Frame:** Week 1, Week 7

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

**Measure:** Change in craving network strength during resting state runs

**Time Frame:** Week 1 and 3

**Description:** 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.

**Measure:** Change in Food Rating Task healthiness, tastiness, and choice scores

**Time Frame:** Week 1, Week 7

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

**Measure:** Change in Food Snack Task caloric intake

**Time Frame:** Week 1 and 3

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** kathleen.garrison@yale.edu

**Name:** Kathleen A Garrison, PhD

**Phone:** 2037376232

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M26186

- Name: Overweight

- Relevance: HIGH

- As Found: Overweight

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000050177

- Term: Overweight

### Misc Info Module

- Version Holder: 2024-05-31
