The Retrain Your Brain for Healthy Eating Study

NYU Langone Health

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Food Response Training (FRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05203718

21-00889

Details and patient eligibility

About

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).

Enrollment: 35 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Patients with Obesity

Experimental group

Description:

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

Treatment:

Behavioral: Food Response Training (FRT)