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Completed

NCT Number: NCT05203718

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).

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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

Exclusion criteria

  • 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.

Treatment and study plan

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/).

Primary outcomes

  1. Rate of Intervention Uptake

    Time frame: Baseline (Day 0)

    This will be reported as the number of participants who are enrolled and assessed for eligibility.

  2. Rate of Intervention Retention

    Time frame: Week 12

    This will be reported as the number of 12-week survey completers / total enrolled participants.

  3. Health Eating Index (HEI-2015) Score

    Time frame: 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.

Secondary outcomes

  1. Change in Weight (kg)

    Time frame: Baseline, Week 12

  2. Change in Blood Pressure (BP)

    Time frame: Baseline, Week 12

  3. Change in Waist Circumference (cm)

    Time frame: Baseline, Week 12

  4. Change in Hip Circumference (cm)

    Time frame: Baseline, Week 12

  5. Change in Neck Circumference (cm)

    Time frame: Baseline, Week 12

  6. Change in Food Cravings Questionnaire - Trait (FCQ-T) Score

    Time frame: 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.

  7. Change in Yale Food Addiction Scale (YFAS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • American Heart Association

Registry information

Official study title

A Mixed Methods, Single-group, Single-center Feasibility Study of a Food Response Training to Reduce Unhealthy Dietary Intake and Promote Weight Loss in Racially and Ethnically Diverse Patients With Obesity

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 24, 2022
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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