The Retrain Your Brain for Healthy Eating Study

Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05203718
• Other study ID #: 21-00889
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2022
• Est. completion date: October 2024

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: Sandra Wittleder, PhD
• Phone: 212-263-4149
• Email: Sandra.wittleder[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• 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/).

Locations

Country	Name	City	State
United States	NYU Clinical & Translational Science Institute Clinical Research Center (CTSI CRC)	New York	New York
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Intervention Uptake	This will be reported as the number of participants who are enrolled and assessed for eligibility.	Baseline (Day 0)
Primary	Rate of Intervention Retention	This will be reported as the number of 12-week survey completers / total enrolled participants.	Week 12
Primary	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	Change in Weight (kg)		Baseline, Week 12
Secondary	Change in Blood Pressure (BP)		Baseline, Week 12
Secondary	Change in Waist Circumference (cm)		Baseline, Week 12
Secondary	Change in Hip Circumference (cm)		Baseline, Week 12
Secondary	Change in Neck Circumference (cm)		Baseline, Week 12
Secondary	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.	Baseline, Week 12
Secondary	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.	Baseline, Week 12