A Program for the Comprehensive Cognitive Training of Excess Weight (TRAINEP): The Study Protocol for A Randomized, Controlled Trial

Abstract

Background: The available treatments for people with excess weight have shown small effects. Cognitive training has shown promising results, but most of the research focused on normalweight university students and reported immediate results after a single training session. This parallel group, randomized, controlled trial aims to study the efficacy of a program for the comprehensive cognitive treatment of excess weight. Methods and Analysis: Participants will be 150 people with excess weight recruited through social media, who will be randomized into three groups: cognitive intervention, sham cognitive intervention, and treatment as usual. All assessment and intervention sessions will be online in groups of 5–6 participants. The three groups will attend a motivational interviewing session, and they will receive individualized diet and physical exercise guidelines throughout the program. The cognitive training will consist of four weekly sessions of approximately 60–90 min, each based on approach–avoidance bias training, inhibitory control training, implementation of intentions, and episodic future thinking, respectively. The main outcome measure will be a change in Body Mass Index (kg/m2). Secondary outcomes include changes in cognitive measures, eating and physical exercise behaviors, and anthropometric measures. Assessments will be conducted up to 6 months after the end of the program. In addition, data on the use of the health system will be collected to analyze the cost-effectiveness and the cost-utility of training. Linear mixed models will be used for statistical analysis. Findings of this study will expand the available evidence on cognitive interventions to reduce excess weight.