Effect of a patient education program focused on weight stigma on quality of life and self-efficacy in patients living with obesity: study protocol for a randomized controlled trial

After a literature review and interviews with patients living with obesity, key psychosocial determinants such as coping strategies, weight bias internalization, body dissatisfaction and self-efficacy were identified as critical to address obesity-related stigma. The intervention was tailored using evidence-based techniques and input from health professionals to ensure relevance and avoid redundancy. This randomized controlled trial (RCT) aims to evaluate the effect of an intervention specifically designed to address weight stigma among individuals living with obesity.

The study compares two parallel arms following different interventions: Patient Education as Usual (PEU) program and the newly developed Patient Education STEREOBES (PES) program, which integrates additional components to counteract weight stigma. The PES program, crafted using the Intervention Mapping process, addresses key psychosocial determinants such as self-efficacy, body image, and coping strategies. It incorporates workshops focused on psychoeducation, physical activity, and emotional regulation through innovative techniques like mindfulness, assertiveness training, and Acceptance and Commitment Therapy (ACT). The program emphasizes group activities and patient interaction to foster resilience against stigmatizing experiences and promote healthier lifestyle choices. This comprehensive intervention is designed to improve psychological, behavioral, and physical outcomes, particularly by reducing the internalization of weight bias and enhancing coping mechanisms.

Patients in the PES arm should demonstrate significant improvements in quality of life and self-efficacy compared to the PEU arm. Psychosocial factors should mediate the effect of the intervention on the outcomes involving quality of life and behaviors. This study will provide valuable insights into the role of weight stigma in obesity treatment and the effectiveness of targeted interventions.

This research protocol has been approved by the Individual Protection Committee Northwest IV (National n°2023-A00327-38) and registered on Clinicaltrial.gov (NCT05906238) on June 7, 2023.