Targeting Food Cue Reactivity and Satiety Sensitivity to Decrease Binge Eating and Weight
Abstract
The purpose of the study is to compare a novel treatment, named Regulation of Cues (ROC), to Cognitive Behavior Therapy (CBT), to address binge eating and weight loss in veterans. The objectives of the study are: 1) to evaluate feasibility and acceptability of ROC and CBT and 2) to evaluate the efficacy of both treatments on reduction of binge eating and weight among 120 Veterans with subclinical or clinical Binge Eating Disorder (BED) with comorbid overweight/obesity (OW/OB). By the end of Year 4, 131 participants were randomized into treatment. All treatments were completed. All assessments were completed for Cohort 1-4. Due to the COVID-19 pandemic related delay in recruitment from Q3 Year 3 through Q1 Year 4, DoD approved one-year no cost extension (NCE) to complete the last Cohort 5 6-month follow-up assessments and related data entry, cleaning, and auditing. Statistical analyses of primary aims will be completed by Q4 Year 5 while secondary and exploratory aim analyses will most likely be completed after the NCE. No unanticipated problems involving risk to subjects or others have occurred since the study began. Regulatory documents, amendments to research protocols, adverse events, and protocol deviations were submitted in a timely manner and approved/acknowledged by local IRBs and DoD HRPO.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2022
- Accession Number
- AD1194065
Entities
People
- Kerri Boutelle
Organizations
- University of California, San Diego