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The Retrain Your Brain for Healthy Eating Study

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Food Response Training (FRT)
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Food Response Training (FRT)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NYU Clinical & Translational Science Institute Clinical Research Center (CTSI CRC)Recruiting
  • NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with Obesity

Arm Description

NYU Langone Health patients ≥18 to 80 years of age with a BMI ≥30.0 kg/m2

Outcomes

Primary Outcome Measures

Rate of Intervention Uptake
This will be reported as the number of participants who are enrolled and assessed for eligibility.
Rate of Intervention Retention
This will be reported as the number of 12-week survey completers / total enrolled participants.
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.

Secondary Outcome Measures

Change in Weight (kg)
Change in Blood Pressure (BP)
Change in Waist Circumference (cm)
Change in Hip Circumference (cm)
Change in Neck Circumference (cm)
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.
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.

Full Information

First Posted
January 20, 2022
Last Updated
June 13, 2023
Sponsor
NYU Langone Health
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT05203718
Brief Title
The Retrain Your Brain for Healthy Eating Study
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
American Heart Association

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Food Response Training (FRT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with Obesity
Arm Type
Experimental
Arm Description
NYU Langone Health patients ≥18 to 80 years of age with a BMI ≥30.0 kg/m2
Intervention Type
Behavioral
Intervention Name(s)
Food Response Training (FRT)
Intervention Description
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/).
Primary Outcome Measure Information:
Title
Rate of Intervention Uptake
Description
This will be reported as the number of participants who are enrolled and assessed for eligibility.
Time Frame
Baseline (Day 0)
Title
Rate of Intervention Retention
Description
This will be reported as the number of 12-week survey completers / total enrolled participants.
Time Frame
Week 12
Title
Health Eating Index (HEI-2015) Score
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change in Weight (kg)
Time Frame
Baseline, Week 12
Title
Change in Blood Pressure (BP)
Time Frame
Baseline, Week 12
Title
Change in Waist Circumference (cm)
Time Frame
Baseline, Week 12
Title
Change in Hip Circumference (cm)
Time Frame
Baseline, Week 12
Title
Change in Neck Circumference (cm)
Time Frame
Baseline, Week 12
Title
Change in Food Cravings Questionnaire - Trait (FCQ-T) Score
Description
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.
Time Frame
Baseline, Week 12
Title
Change in Yale Food Addiction Scale (YFAS)
Description
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.
Time Frame
Baseline, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥18 to 80 years of age BMI ≥30.0 kg/m2 access to a computer or an iPhone/iPad or be willing to use a study loaner smart phone Exclusion Criteria: pregnant or breastfeeding or plan to become pregnant in the next 6 months, or who become pregnant during the study 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 enrolled in another intervention that could influence dietary intake have had bariatric surgery within the past 2 years unwilling to delay bariatric surgery for the next 6 months who have gained or loss more than 5.5 kg in the previous 3 months 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) 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Wittleder, PhD
Phone
212-263-4149
Email
Sandra.wittleder@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Sweat, MS
Email
Victoria.sweat@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Jay, MD, MS
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandra Wittleder, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Clinical & Translational Science Institute Clinical Research Center (CTSI CRC)
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Jay, MD, MS
First Name & Middle Initial & Last Name & Degree
Sandra Wittleder, PhD
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Jay, MD, MS
First Name & Middle Initial & Last Name & Degree
Sandra Wittleder, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

The Retrain Your Brain for Healthy Eating Study

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