The Retrain Your Brain for Healthy Eating Study
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 Start (Actual) 9 November 2022
🗓️ Primary Completion (Estimated) October 2024
✅ Study Completion (Estimated) October 2024
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New York, New York, United States
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 January 2022
  • First Submitted that Met QC Criteria 20 January 2022
  • First Posted 24 January 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 March 2024
  • Last Update Posted 19 March 2024
  • Last Verified March 2024