Effectiveness of a Mindfulness-Based Intervention + Standard Diet Treatment Compared to Standard Diet Treatment Alone on Food Cravings in Overweight/Obese Individuals With Mild to Moderate Anxiety/Depression: A Study Protocol for an Open-Labeled, Parallel-Group Randomized Controlled Trial Publisher Pubmed

Summary: Study tests if mindfulness audio files help obese adults with anxiety reduce food cravings & manage weight. May offer a simple, remote solution. #Obesity #Mindfulness

Sa Allameh Seyed AMIRHOSSEIN ; Z Mokhtari ZEINAB ; G Askari GHOLAMREZA
Source: Trials Published:2025

Abstract

Background: Overweight/obesity is highly prevalent worldwide. Dropping out of weight loss diets is one of the main reasons for treatment failure in obese individuals. Evidence indicates a significant relationship between anxiety/depression and overweight/obesity. Up to 11% of excess food consumption and the resulting overweight have been attributed to food cravings. Mindfulness-based interventions (MBIs) have recently become a topic of interest in the treatment of obesity-related eating behaviors. The use of recorded audio files has shown promising results in different studies. However, these studies were mainly conducted under laboratory conditions with short follow-up periods. Purpose: To explore the effects of a remotely delivered ME intervention outside laboratory conditions regarding FC intensity and its related outcomes in adults with overweight/obesity suffering from mild to moderate anxiety. Methods: We will conduct this study in the form of an open-label parallel-group superiority 1:1 randomized controlled trial. The intervention group will receive a 2-week mindfulness and ME course, delivered remotely via audio files, in conjunction with a standard diet program, whereas the control group will receive diet therapy alone. Patients will be followed up for 14 weeks. Conclusion: The results will inform whether this easily accessible method can help these individuals correct their unhealthy food behaviors, better cope with their anxiety/depression, and achieve or maintain their weight goals. Trial registration: A protocol of the trial has been prospectively registered by the Iranian Registry of Clinical Trials on January 9th, 2024. Registration code: IRCT20210507051204N2. © 2025 Elsevier B.V., All rights reserved.