Obesity is currently a major public health challenge in France, particularly in the Hauts-de-France region, where prevalence exceeds 20% of the adult population. Bariatric surgery has considerably increased over the last two decades and is now recognized as an effective therapeutic option within a multidisciplinary care pathway. However, many patients continue to experience difficulties related to body image, emotional regulation, problematic eating behaviors, and long-term adherence to adapted physical activity (APA), which may limit the sustainability of treatment benefits. International literature highlights the importance of integrating psychological and psychosocial support alongside medical, nutritional, and physical interventions.

This monocentric randomized controlled trial aims to evaluate the effects of adding dramatherapy (DT) to a standardized APA program in adult patients with obesity enrolled in medical or bariatric care pathways at the Institut de l'Obésité of Clinique ELSAN Saint-Omer (France). Participants will be randomized to receive either standard APA alone or APA combined with DT. The intervention is designed to improve emotional expression, body perception, self-confidence, psychosocial well-being, and long-term adherence to care. Dramatherapy sessions will include theatrical expression, role play, improvisation, relaxation, and body-oriented creative exercises adapted to patients with obesity.

The primary objective is to evaluate the effect of DT on quality of life at the end of care, compared with APA alone, using the French version of the EQVOD questionnaire. Secondary objectives include the evaluation of eating behaviors and problematic eating regulation (TFEQ-R18, SCOFF), body image and body-related quality of life (BIQLI), self-efficacy (GSES), anxiety and depressive symptoms (BDI-II), adherence to APA programs, and anthropometric parameters such as body mass index, abdominal circumference, and body composition. Assessments will be conducted at baseline, at the end of the intervention, and at 6- and 12-month follow-up.

The study also includes a complementary qualitative component based on semi-structured interviews, ethnographic observation, body mapping, and identity boxes in order to explore patients' subjective experiences, psychosocial trajectories, and perceived impact of the intervention. Quantitative and qualitative data will be analyzed using a mixed-methods approach. A total of 250 participants are expected to be included. This study seeks to provide evidence regarding the potential added value of integrating dramatherapy into obesity and bariatric care pathways.

Obesity is a major public health concern worldwide and represents a particularly important challenge in France and in the Hauts-de-France region, where prevalence rates exceed 20% of the adult population. Obesity is associated with increased morbidity and mortality, including cardiovascular diseases, type 2 diabetes, respiratory disorders, musculoskeletal conditions, and psychological distress. In this context, bariatric surgery has become an increasingly common therapeutic option for patients with severe obesity and is currently integrated into multidisciplinary care pathways including medical follow-up, nutritional counseling, psychological support, and adapted physical activity (APA).

Despite the recognized effectiveness of bariatric surgery and APA programs, many patients continue to experience difficulties related to body image, emotional regulation, self-esteem, problematic eating behaviors, and long-term adherence to lifestyle changes. These psychosocial dimensions may negatively affect the sustainability of treatment benefits and contribute to weight regain or reduced quality of life over time. International literature therefore emphasizes the importance of comprehensive interventions integrating psychological and psychosocial support alongside standard medical and nutritional care.

Adapted physical activity is recognized as an essential component of obesity and bariatric care. APA contributes to improvements in physical condition, body composition, psychological well-being, and quality of life. However, long-term adherence to physical activity programs remains challenging for many patients, particularly because of stigma, altered body perception, anxiety related to movement, and low self-confidence.

Dramatherapy (DT) is a creative therapeutic approach using theatrical tools such as role play, improvisation, embodiment, storytelling, symbolic expression, and group interaction to facilitate emotional expression, body awareness, psychosocial adjustment, and identity reconstruction. Although dramatherapy and related creative arts therapies have shown promising effects in mental health and psychosocial rehabilitation, their integration into obesity and bariatric care pathways remains largely underexplored. To date, no randomized controlled trial has systematically evaluated the effects of combining dramatherapy with adapted physical activity in patients with obesity enrolled in medical or bariatric care pathways.

The present study is a monocentric randomized controlled trial conducted at the Institut de l'Obésité of Clinique ELSAN Saint-Omer (France), in collaboration with the URePSSS research laboratory (ULR 7369, Université du Littoral Côte d'Opale). The study aims to evaluate the effects of adding dramatherapy to a standardized APA program in adult patients with obesity participating in either a medical obesity care pathway or a bariatric surgery pathway.

Participants will be recruited during routine consultations within the obesity care program. Eligible participants are adults aged 18 years or older with:

• BMI ≥ 40 kg/m²;
• or BMI ≥ 35 kg/m² with obesity-related comorbidities;
• or BMI ≥ 30 kg/m² associated with eating disorders or problematic eating behaviors.

Participants must be enrolled in a medical or bariatric care pathway including APA, be able to participate in the study procedures, and provide written informed consent. Exclusion criteria include major medical contraindications to APA or group participation, severe unstable psychiatric disorders, severe cognitive impairment, unstable medical treatment significantly affecting weight or mental health, inability to comply with follow-up procedures, or inability to provide informed consent.

The study follows a randomized controlled design with two parallel groups:

1. Standardized adapted physical activity alone (control group);
2. Standardized adapted physical activity combined with dramatherapy (experimental group).

Randomization will be stratified according to care pathway type (medical versus bariatric). The study uses a two-stage randomized consent design inspired by Zelen methodology. Participants initially consent to participation and randomization, while a second specific consent is requested only from patients allocated to the additional dramatherapy intervention.

The APA program consists of 12 supervised sessions over 6 weeks, delivered by qualified APA professionals. Sessions include cardiovascular exercises, muscle strengthening, and progressive movement activities adapted to the physical capacities of patients with obesity.

The dramatherapy intervention is delivered by a qualified and experienced dramatherapist. It consists of six weekly group sessions lasting approximately 90 minutes each. The intervention uses theatrical expression, role play, improvisation, breathing exercises, body-oriented activities, symbolic work, and collective interaction to improve body awareness, emotional regulation, self-esteem, social interaction, and engagement in care. For patients enrolled in bariatric pathways, dramatherapy may be delivered during pre-operative and/or post-operative phases depending on the timing of inclusion.

The primary objective is to evaluate the effect of adding dramatherapy to APA on quality of life at the end of care compared with APA alone. Quality of life will be assessed using the French version of the EQVOD questionnaire.

Secondary objectives include evaluating:

• eating behaviors and problematic eating regulation using the TFEQ-R18 and SCOFF questionnaires;
• body image and body-related quality of life using the BIQLI;
• self-efficacy using the General Self-Efficacy Scale (GSES);
• anxiety and depressive symptoms using the Beck Depression Inventory-II (BDI-II);
• adherence and participation in APA programs;
• anthropometric outcomes including body mass index, abdominal circumference, and body composition.

Assessments will be performed at several time points:

• baseline/pre-care assessment;
• beginning of care;
• end of care;
• 6-month follow-up;
• 12-month follow-up.

The study also includes a complementary qualitative and ethnographic component intended to enrich interpretation of quantitative findings and explore the subjective experience of participants. Semi-structured interviews, participant observation, body mapping techniques, and identity boxes will be used to investigate body perception, emotional experiences, psychosocial trajectories, relationship to food and movement, and perceptions of dramatherapy and obesity care pathways.

Quantitative analyses will include descriptive statistics, repeated-measures analyses, mixed linear models, subgroup analyses, and exploratory multivariate analyses. Qualitative data will be analyzed using thematic content analysis and triangulated with quantitative findings within a mixed-methods framework.

The target sample size is 250 participants. This sample size was determined to ensure adequate statistical power for the primary outcome analysis while accounting for potential attrition during long-term follow-up.

The expected duration of inclusion is approximately 1 year and 6 weeks. Individual participation lasts 6 weeks for the intervention phase, with follow-up assessments extending to 12 months. The total duration of the research project is estimated at 36 months.

This study aims to provide new evidence regarding the integration of creative therapeutic approaches into obesity and bariatric care pathways and to evaluate whether combining dramatherapy with adapted physical activity may improve psychological well-being, body-related outcomes, adherence to care, and quality of life in patients with obesity.

Inclusion Criteria:

• Age 18 years or older.
• Body mass index (BMI) ≥ 40 kg/m², or BMI ≥ 35 kg/m² with obesity-related comorbidities, or BMI ≥ 30 kg/m² with associated eating disorders or problematic eating behaviors.
• Enrollment in a medical or bariatric care pathway at the Institut de l'Obésité, Clinique ELSAN Saint-Omer, including a therapeutic education program with adapted physical activity.
• Availability and willingness to complete the planned study procedures and follow-up assessments.
• Written informed consent provided after complete information about the study.
• Affiliation to a social security system.

Exclusion Criteria:

• Major medical contraindications to adapted physical activity or group sessions, including unstable cardiovascular disease or severe non-compensable locomotor limitations.
• Severe psychiatric disorders or severe unstable eating disorders contraindicating bariatric surgery or preventing adequate participation in group sessions.
• Major cognitive impairment or neuropsychological disorders preventing understanding of instructions or completion of assessments.
• Unstable medical treatment or recent therapeutic modification likely to significantly affect body weight, fatigability, or mental health.
• Inability to complete the full study protocol, including prolonged unavailability or planned relocation outside the region.
• Refusal or inability to provide informed consent.
• Major logistical barriers preventing access to the intervention site without feasible alternative arrangements.
• Participation in a structured adapted physical activity program within the 3 months preceding inclusion.

This study collects sensitive psychosocial, behavioral, and qualitative data related to obesity, eating behaviors, mental health, and body image. Individual participant data will not be publicly shared in order to protect participant confidentiality and in accordance with French data protection regulations (CNIL/MR001 framework).

Due to the nature of the intervention, participants and care providers cannot be blinded to group allocation. However, outcome assessors and data analysts will remain blinded to allocation in order to reduce assessment bias. All physical and questionnaire-based evaluations will be conducted using standardized procedures at each study timepoint.