The Retrain Your Brain for Healthy Eating Study

NCT ID: NCT05203718

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-09
• Study Completion Date: 2025-04-09

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).

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with Obesity

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

Group Type: EXPERIMENTAL

Food Response Training (FRT)

Intervention Type: BEHAVIORAL

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/).

Interventions

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/).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

American Heart Association

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melanie Jay, MD, MS

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Sandra Wittleder, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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

Countries

United States

Other Identifiers

21-00889

Identifier Type: -

Identifier Source: org_study_id