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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
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/).
NYU Clinical & Translational Science Institute Clinical Research Center (CTSI CRC)
New York, New York, United States
NYU Langone Health
New York, New York, United States
Rate of Intervention Uptake
This will be reported as the number of participants who are enrolled and assessed for eligibility.
Time frame: Baseline (Day 0)
Rate of Intervention Retention
This will be reported as the number of 12-week survey completers / total enrolled participants.
Time frame: 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.
Time frame: Week 12
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
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.
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Time frame: 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.
Time frame: Baseline, Week 12