ObesityNCT05203718
The Retrain Your Brain for Healthy Eating Study
A study testing Food Response Training (FRT) in people with Obesity, run by NYU Langone Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obesity
- What is being tested?
- Food Response Training (FRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Nov 2022to 9 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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:
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NYU Clinical & Translational Science Institute Clinical Research Center (CTSI CRC)
New York, New York, 10016
NYU Langone Health
New York, New York, 10016
About this study
Official 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
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
- Being tested
- Food Response Training (FRT)
- Keywords
- Food Response Training (FRT)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Response Training (FRT)Behavioural
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/).
| Study group | Role | What they receive |
|---|---|---|
| Patients with Obesity | Experimental | NYU Langone Health patients ≥18 to 80 years of age with a BMI ≥30.0 kg/m2 Receives: Behavioral: Food Response Training (FRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Intervention Uptake
This will be reported as the number of participants who are enrolled and assessed for eligibility.
Measured: Baseline (Day 0)
Rate of Intervention Retention
This will be reported as the number of 12-week survey completers / total enrolled participants.
Measured: 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.
Measured: Week 12
Secondary outcomes (7)
Change in Weight (kg)
Measured: Baseline, Week 12
Change in Blood Pressure (BP)
Measured: Baseline, Week 12
Change in Waist Circumference (cm)
Measured: Baseline, Week 12
Change in Hip Circumference (cm)
Measured: Baseline, Week 12
Change in Neck Circumference (cm)
Measured: Baseline, Week 12
Change in Food Cravings Questionnaire - Trait (FCQ-T) Score
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.
Measured: Baseline, Week 12
Change in Yale Food Addiction Scale (YFAS)
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.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start9 Nov 2022
- Primary completion9 Apr 2025
- Study completion9 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Melanie Jay, MD, MS, Principal investigator, NYU Langone HealthSandra Wittleder, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203718
- Sponsor's protocol ID
- 21-00889
- Status last verified
- May 2025
- First submitted
- 20 Jan 2022
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05203718
- Acronym / sponsor ID
- 21-00889
- Conditions
- Obesity
- Keywords
- Food Response Training (FRT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 9 Apr 2025 (actual)
- Study completion
- 9 Apr 2025 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Obesity | Experimental | Behavioral: Food Response Training (FRT)NYU Langone Health patients ≥18 to 80 years of age with a BMI ≥30.0 kg/m2 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥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
Key exclusion criteria (9 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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/). | Behavioural | Patients with Obesity |
Primary outcome
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.
Rate of Intervention Retention
Time frame: Week 12
This will be reported as the number of 12-week survey completers / total enrolled participants.
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.
7 secondary outcomes
Change in Weight (kg)
Time frame: Baseline, Week 12
Change in Blood Pressure (BP)
Time frame: Baseline, Week 12
Change in Waist Circumference (cm)
Time frame: Baseline, Week 12
Change in Hip Circumference (cm)
Time frame: Baseline, Week 12
Change in Neck Circumference (cm)
Time frame: Baseline, Week 12
Change in Food Cravings Questionnaire - Trait (FCQ-T) Score
Time frame: Baseline, Week 12
Change in Yale Food Addiction Scale (YFAS)
Time frame: Baseline, Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Jay, MD, MS principal investigator
NYU Langone Health
Sandra Wittleder, PhD principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Response Training (FRT) in people with Obesity, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Intervention Uptake (time frame: Baseline (Day 0)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.