Clinical trial NCT05203718: The Retrain Your Brain for Healthy Eating 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Food Response Training (FRT)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2022-01-24
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Intervention Uptake
timeFrame: Baseline (Day 0)
measure: Rate of Intervention Retention
timeFrame: Week 12
measure: Health Eating Index (HEI-2015) Score
timeFrame: Week 12
Secondary outcomes:
measure: Change in Weight (kg)
timeFrame: Baseline, Week 12
measure: Change in Blood Pressure (BP)
timeFrame: Baseline, Week 12
measure: Change in Waist Circumference (cm)
timeFrame: Baseline, Week 12
measure: Change in Hip Circumference (cm)
timeFrame: Baseline, Week 12
measure: Change in Neck Circumference (cm)
timeFrame: Baseline, Week 12
measure: Change in Food Cravings Questionnaire - Trait (FCQ-T) Score
timeFrame: Baseline, Week 12
measure: Change in Yale Food Addiction Scale (YFAS)
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Clinical & Translational Science Institute Clinical Research Center (CTSI CRC)
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Melanie Jay, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Sandra Wittleder, PhD
role: PRINCIPAL_INVESTIGATOR
References: