Intermittent theta burst stimulation (iTBS) and inhibitory control training for excess weight treatment: study protocol for a randomized controlled trial (InhibE).

backgroundThe prevalence of excess weight has increased globally. Despite interventions include targeted goals on essential aspects such as physical activity and diet, their long-term effectiveness remains limited. Research highlights that eating behaviour is influenced by impulsive processes, especially in the context of a food-rich environment. Inhibitory control has been identified as a key factor in regulating eating behaviour. Neuroscience approaches, including inhibitory control training and non-invasive neuromodulation of brain regions such as the dorsolateral prefrontal cortex, show promise in improving eating behaviour when used in addition to conventional intervention for weight management. This parallel group, randomized, controlled trial aims to study the efficacy of neuromodulation with iTBS as an add-on to the weight loss treatment as usual (TAU: diet and exercise), alone and in combination with inhibitory control training, for excess weight treatment. METHODS AND ANALYSIS: 141 people with excess weight will be randomized into three groups: combined intervention (inhibitory control training + iTBS), iTBS and sham iTBS. The three groups will receive individualized diet and physical exercise guidelines (TAU). The interventions will comprehend ten sessions along two weeks. The main outcome measure will be the Body Mass Index change. Secondary outcomes include changes in brain connectivity and activation using fMRI, cognitive measures, eating and physical exercise behaviours, anthropometric and biological measures. Assessments will be carried out before the intervention, after the intervention and 3 months after the intervention. In addition, data on the use of the health system will be collected to analyse the cost-effectiveness and the cost-utility of the intervention. DISCUSSION: Findings of this study will expand the available evidence on cognitive interventions to improve eating behaviour in people with excess weight.

trial registrationThe trial has been registered at www. CLINICALTRIALS: gov under the number NCT06668077 on the 11th of February 2025 named Inhibitory Control Training and iTBS for Excess Weight Behavioral and Brain Changes (InhibE). Any relevant modification to the protocol will be reflected in the clinical trial registry in www. CLINICALTRIALS: gov.