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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
250
Standardized supervised adapted physical activity program including cardiovascular exercises, muscle strengthening, and progressive movement activities adapted to patients with obesity. The program consists of 12 sessions delivered over 6 weeks by qualified APA professionals.
Group dramatherapy intervention including theatrical expression, role play, improvisation, breathing and relaxation exercises, body-oriented creative activities, and collective interaction aimed at improving emotional expression, body image, self-confidence, and psychosocial well-being.
Clinique Elsan de Saint Omer
Blendecques, Hauts-de-France, France
RECRUITINGChange in Quality of Life Assessed by the Échelle Qualité de Vie, Obésité et Diététique / Quality of Life, Obesity and Dietetics Global Score
Quality of life will be assessed using the global score of the French version of the Échelle Qualité de Vie, Obésité et Diététique (EQVOD), also known as the Quality of Life, Obesity and Dietetics (QOLOD) rating scale. The EQVOD/QOLOD is an obesity-specific quality-of-life questionnaire. Scores are transformed to a 0-100 scale, with higher scores indicating better health-related quality of life. The primary endpoint is the between-group difference in EQVOD/QOLOD global score at the end of care, adjusted for baseline values. In the absence of a validated minimal clinically important difference for this population, a distribution-based approach will be used, considering a difference of 0.5 standard deviation in the global score as clinically meaningful.
Time frame: Baseline and end of care 6 weeks, 6 months, 12 months
Change in Eating Disorder Screening Score Assessed by the SCOFF Questionnaire
Eating disorder screening indicators will be assessed using the Sick, Control, One Stone, Fat, Food questionnaire (SCOFF). The SCOFF total score ranges from 0 to 5, with higher scores indicating more eating disorder screening indicators and a higher risk of eating disorders or problematic eating behaviors. A score of 2 or more is commonly considered indicative of possible eating disorder risk requiring further clinical assessment.
Time frame: Baseline, end of care approximately 6 weeks, 6 months, and 12 months
Change in Eating Behaviors Assessed by the Three-Factor Eating Questionnaire-Revised 18-Item Version
Eating behaviors will be assessed using the Three-Factor Eating Questionnaire-Revised 18-item version (TFEQ-R18). The TFEQ-R18 assesses three dimensions of eating behavior: cognitive restraint, uncontrolled eating, and emotional eating. Each subscale score is transformed to a 0-100 scale. Higher scores indicate a higher level of the corresponding eating behavior: greater cognitive restraint, greater uncontrolled eating, or greater emotional eating.
Time frame: Baseline, end of care (6 weeks), 6 months, and 12 months
Change in Body Image-Related Quality of Life Assessed by the Body Image Quality of Life Inventory
Body image-related quality of life will be assessed using the Body Image Quality of Life Inventory (BIQLI). The BIQLI is a 19-item self-report questionnaire assessing the impact of body image on different areas of daily life and psychosocial well-being. Each item is scored from -3 to +3. The global mean score ranges from -3 to +3, with higher scores indicating a more positive impact of body image on quality of life and therefore a better outcome.
Time frame: Baseline, end of care (6 weeks), 6 months, and 12 months
Change in Self-Efficacy Assessed by the General Self-Efficacy Scale
Self-efficacy will be assessed using the General Self-Efficacy Scale (GSES). The GSES is a 10-item self-report questionnaire evaluating participants' perceived ability to cope with difficult situations and maintain behavioral changes related to health, physical activity, and eating behaviors. Each item is scored from 1 to 4, and the total score ranges from 10 to 40. Higher scores indicate higher perceived self-efficacy and therefore a better outcome.
Time frame: Baseline, end of care (6 weeks), 6 months, and 12 months
Change in Depressive Symptoms Assessed by the Beck Depression Inventory-Second Edition
Depressive symptoms will be assessed using the Beck Depression Inventory-Second Edition (BDI-II). The BDI-II is a 21-item self-report questionnaire evaluating the severity of depressive symptoms. Each item is scored from 0 to 3, and the total score ranges from 0 to 63. Higher scores indicate greater depressive symptom severity and therefore a worse outcome.
Time frame: Baseline, end of care (6 weeks), 6 months, and 12 months
Adherence to Adapted Physical Activity Assessed by Attendance Rate
Adherence to the adapted physical activity (APA) program will be assessed using attendance records. The attendance rate will be calculated as the percentage of scheduled APA sessions attended by each participant. The score ranges from 0% to 100%, with higher percentages indicating greater adherence to the APA program and therefore a better outcome.
Time frame: During the 6 week period
Change in Body Mass Index
Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared and reported in kg/m². Lower BMI values over time indicate a reduction in body mass index and generally a better outcome in the context of obesity care.
Time frame: Baseline, end of care (6 weeks), 6 months, and 12 months
Change in Body Weight
Body weight will be measured using standardized clinical procedures and reported in kilograms. Lower body weight values over time indicate weight reduction and generally a better outcome in the context of obesity care.
Time frame: Baseline, end of care approximately 6 weeks, 6 months, and 12 months
Change in Abdominal Circumference
Abdominal circumference will be measured using standardized clinical procedures and reported in centimeters. Lower abdominal circumference values over time indicate a reduction in abdominal adiposity and generally a better outcome in the context of obesity care.
Time frame: Baseline, end of care approximately 6 weeks, 6 months, and 12 months
Change in Body Composition Assessed by Bioimpedance Analysis
Body composition will be assessed using bioimpedance analysis. The main reported parameter will be body fat percentage, expressed as a percentage of total body weight. Lower body fat percentage values over time indicate a reduction in body fat and generally a better outcome in the context of obesity care.
Time frame: Baseline, end of care approximately 6 weeks, 6 months, and 12 months
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