Effect of Dramatherapy Combined With Adapted Physical Activity on Psychological and Social Well-Being in Patients With Obesity and Eating Disorders in Medical and Bariatric Care: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Change in Quality of Life Assessed by the Échelle Qualité de Vie, Obésité et Diététique / Quality of Life, Obesity and Dietetics Global Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Quality of Life Assessed by the Échelle Qualité de Vie, Obésité et Diététique / Quality of Life, Obesity and Dietetics Global Score
时间窗: Baseline and end of care 6 weeks, 6 months, 12 months
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.
次要结局
- Change in Eating Disorder Screening Score Assessed by the SCOFF Questionnaire(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(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(Baseline, end of care (6 weeks), 6 months, and 12 months)
- Change in Self-Efficacy Assessed by the General Self-Efficacy Scale(Baseline, end of care (6 weeks), 6 months, and 12 months)
- Change in Depressive Symptoms Assessed by the Beck Depression Inventory-Second Edition(Baseline, end of care (6 weeks), 6 months, and 12 months)
- Adherence to Adapted Physical Activity Assessed by Attendance Rate(During the 6 week period)
- Change in Body Mass Index(Baseline, end of care (6 weeks), 6 months, and 12 months)
- Change in Body Weight(Baseline, end of care approximately 6 weeks, 6 months, and 12 months)
- Change in Abdominal Circumference(Baseline, end of care approximately 6 weeks, 6 months, and 12 months)
- Change in Body Composition Assessed by Bioimpedance Analysis(Baseline, end of care approximately 6 weeks, 6 months, and 12 months)