The Retrain Your Brain for Healthy Eating Study

NCT05203718 | Completed

• 1 other identifier: 21-00889
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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

Keywords

Food Response Training (FRT)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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

Study Arms (1)

Patients with Obesity

EXPERIMENTAL

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

Behavioral: Food Response Training (FRT)

Interventions

Food Response Training (FRT) 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/).

Patients with Obesity

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• American Heart Association: collaborator

Study Sites (2)

NYU Clinical & Translational Science Institute Clinical Research Center (CTSI CRC)

New York, New York, 10016, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Melanie Jay, MD, MS

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Sandra Wittleder, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: January 24, 2022
• Study Start: November 9, 2022
• Primary Completion: April 9, 2025
• Study Completion: April 9, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (2)