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

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 normal-weight 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/m(2)). 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.