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.

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.