The Retrain Your Brain for Healthy Eating Study

A Mixed Methods, Single-group, Single-center Feasibility Study of a Food Response Training to Reduce Unhealthy Dietary Intake and Promote Weight Loss in Racially and Ethnically Diverse Patients With Obesity

The aim of this mixed methods, single-group, single-center study will be to examine the feasibility of a food response training (FRT). This study will be conducted in patients with obesity recruited from NYU Langone Health. Measurements will occur at screening, baseline, and 3 months, for a subgroup of participants for we will collect saliva samples for genetic analysis at baseline assessment (ancillary study).

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Food Response Training (FRT)

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health
    • New York, New York, United States, 10016
      • NYU Clinical & Translational Science Institute Clinical Research Center (CTSI CRC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. ≥18 to 80 years of age
2. BMI ≥30.0 kg/m2
3. access to a computer or an iPhone/iPad or be willing to use a study loaner smart phone

Exclusion Criteria:

1. pregnant or breastfeeding or plan to become pregnant in the next 6 months, or who become pregnant during the study

2. taking any medication that may impact dietary intake and weight:

   a. Immunosuppressants, steroids, medications for weight loss or to manage blood sugars or a psychiatric condition other than anxiety/depression

3. enrolled in another intervention that could influence dietary intake
4. have had bariatric surgery within the past 2 years
5. unwilling to delay bariatric surgery for the next 6 months
6. who have gained or loss more than 5.5 kg in the previous 3 months
7. unable to participate meaningfully in an intervention that involves using software available in English. The reason for this is that the food training apps have not been designed or validated in audio form or in other languages. (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking, dementia)
8. institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over diet), unwilling or inability to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with Obesity; NYU Langone Health patients ≥18 to 80 years of age with a BMI ≥30.0 kg/m2

Behavioral: Food Response Training (FRT); All patients will complete the 12-week FRT intervention consisting of one in-person session (during the baseline visit) and three weekly sessions at home, one delivered via video conference (WebEx) and two self-guided. Food Response Training (FRT) is a computer-based attention bias modification intervention. The intervention will be delivered on a computer or smart device (e.g. iPhone). Patients will use the FoodTrainer application available for Android and iPhone (https://www.exeter.ac.uk/foodt/about/).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Intervention Uptake	This will be reported as the number of participants who are enrolled and assessed for eligibility.	Baseline (Day 0)
Rate of Intervention Retention	This will be reported as the number of 12-week survey completers / total enrolled participants.	Week 12
Health Eating Index (HEI-2015) Score	HEI-2015 is a measure of diet quality used to assess how well a set of foods aligns with key recommendations of the Dietary Guidelines for Americans. The total HEI-2015 score for Americans is 59 out of 100; the higher the score, the more the foods align with key recommendations.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weight (kg)		Baseline, Week 12
Change in Blood Pressure (BP)		Baseline, Week 12
Change in Waist Circumference (cm)		Baseline, Week 12
Change in Hip Circumference (cm)		Baseline, Week 12
Change in Neck Circumference (cm)		Baseline, Week 12
Change in Food Cravings Questionnaire - Trait (FCQ-T) Score	FCQ-T measures the frequency and intensity of food craving experiences in general. The questionnaire has 39 items and response categories range from 1 = never to 6 = always. There are no inverted items. Responses to all items are summed up for a total score. Thus, higher scores represent more frequent and intense food cravings.	Baseline, Week 12
Change in Yale Food Addiction Scale (YFAS)	YFAS is a measure to identify those who are most likely to be exhibiting markers of substance dependence with the consumption of high fat/high sugar foods. The 25 questions are scored with defined cut-offs (0 = question not significantly met, 1 = question criteria met). After computing cut-offs, the questions under each substance dependence criterion are summed. If the score for the criterion is >/= 1, then the criterion has been met and is scored as 1. If the score = 0, then the criteria has not been met. To score the continuous version of the scale, which resembles a symptom count without diagnosis, all of the scores for each criterion are added up. The total score range is 0-7 (0 symptoms to 7 symptoms). The higher the score, the greater the number of symptoms.	Baseline, Week 12

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Melanie Jay, MD, MS, NYU Langone Health; Principal Investigator: Sandra Wittleder, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2022
• Primary Completion (Actual): April 9, 2025
• Study Completion (Actual): April 9, 2025

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 23, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Food Response Training (FRT)
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: 21-00889

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Sandra.wittleder@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes