Two out of every three adults is overweight or obese. Overweight and obesity is associated with significant medical and psychological comorbidities. To date, the most successful weight loss treatment is behavioral weight loss (BWL), which includes nutrition and physical activity education, as well as behavior therapy techniques. Although many adults lose weight in these programs, studies suggest that one third to one half do not respond. Additionally, for those who do lose weight, weight loss maintenance becomes a significant challenge. We have developed a new model for the treatment of obesity, called Regulation of Cues (ROC), which is based on Schachter's Externality Theory. The ROC program targets two theorized mechanisms for overeating in Schachter's Theory; decreased sensitivity to appetitive cues and increased sensitivity to external food cues. We have tested the ROC model with overweight adults who binge eat in a pilot trial. Our initial data showed that participants significantly decreased their BMI during treatment and continued to decrease their BMI at the three month post-treatment time-point. The objective of this proposed study is to further evaluate the ROC program with overweight and obese adults. Considering that BWL has merit for some people, but fails to facilitate maintenance, we propose a 4 arm randomized controlled trial that will compare ROC, BWL, ROC+BWL combined and an attentional control (AC). We will recruit and randomize 280 overweight/obese adults and will assess them at baseline, mid-treatment (month 6), post-treatment (month 12), mid-follow-up (month 18) and follow-up (month 24). Primary and secondary aims are as follows. Primary Aim 1: Compare ROC and ROC+BWL to AC on body mass index (BMI), body composition, and binge eating over the course of treatment and follow-up. Primary Aim 2: Compare ROC and ROC+BWL to BWL on body mass index (BMI), body composition, and binge eating over the course of treatment and follow-up. Secondary Aim 1: Compare ROC, ROC+BWL, BWL and AC on sensitivity to appetitive cues, sensitivity to food cues, inhibition, restriction, caloric intake, overeating, and physical activity over the course of the treatment and follow-up. Exploratory aim 1: Evaluate mediators (sensitivity to appetitive cues, sensitivity to food cues, inhibition, restriction, binge eating, overeating in response to food cues) and moderators (demographics, baseline BMI, binge eating status) on BMI over time in each treatment arm. This program of research is an important next step in the development of treatments for overweight and obese people, and could change the paradigm of obesity treatment. This study will contribute to the study of basic behavioral mechanisms and food intake, could provide a novel model for the treatment of obesity, and could inform clinical decision making regarding obesity treatment.
NIH ExPorter
NIH ExPorter