The Retrain Your Brain for Healthy Eating Study

Not Applicable

Recruiting

• Conditions: Obesity
• Interventions: Behavioral: Food Response Training (FRT)

• Registration Number: NCT05203718
• Lead Sponsor: NYU Langone Health

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-01-24
• Study Start: 2022-11-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-03
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Obesity	Food Response Training (FRT)	NYU Langone Health patients ≥18 to 80 years of age with a BMI ≥30.0 kg/m2

Primary Outcome Measures

Name	Time	Method
Health Eating Index (HEI-2015) Score	Week 12	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.
Rate of Intervention Uptake	Baseline (Day 0)	This will be reported as the number of participants who are enrolled and assessed for eligibility.
Rate of Intervention Retention	Week 12	This will be reported as the number of 12-week survey completers / total enrolled participants.

Secondary Outcome Measures

Name	Time	Method
Change in Waist Circumference (cm)	Baseline, Week 12
Change in Weight (kg)	Baseline, Week 12
Change in Neck Circumference (cm)	Baseline, Week 12
Change in Blood Pressure (BP)	Baseline, Week 12
Change in Yale Food Addiction Scale (YFAS)	Baseline, Week 12	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.
Change in Food Cravings Questionnaire - Trait (FCQ-T) Score	Baseline, Week 12	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 Hip Circumference (cm)	Baseline, Week 12

Trial Locations

Locations (2)

NYU Clinical & Translational Science Institute Clinical Research Center (CTSI CRC); 🇺🇸 New York, New York, United States

NYU Langone Health; 🇺🇸 New York, New York, United States