Obesity (Disorder)NCT07685483
Dramatherapy for Psychological and Social Well-Being in Obesity and Bariatric Care
A study testing Adapted Physical Activity and Dramatherapy in people with Obesity (Disorder) and Obesity & Overweight, run by Universite du Littoral Cote d'Opale at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity (Disorder), Obesity & Overweight, Eating Disorders
- What is being tested?
- Adapted Physical Activity and Dramatherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2026to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique Elsan de Saint Omer
Blendecques, Hauts-de-France, 62575
Morgane Carton, 00 33 3 91 92 50 10, Morgane.Carton@elsan.care
Suzanne Vanachter, PhD Student, 0033672481842, vanachter.s@gmail.com
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
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:
- Standardized adapted physical activity alone (control group);
- 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.
- Being tested
- Adapted Physical Activity, Dramatherapy
- Keywords
- Obesity, Eating Disorders, Bariatric Surgery, Dramatherapy, Art Therapy, Adapted Physical Activity, Body image, Quality of life, Psychosocial Well-Being, Psychosocial intervention, Body Mapping
- Medical subject headings
- Obesity, Overweight, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Physical ActivityBehavioural
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.
DramatherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Adapted Physical Activity | Active comparator | Participants allocated to the control group will receive the standard adapted physical activity (APA) program routinely implemented within the obesity care pathway. The intervention consists of 12 supervised sessions over 6 weeks, including cardiovascular exercises, muscle strengthening, and progressive movement activities adapted to the physical capacities and clinical condition of patients with obesity. Sessions are delivered by qualified APA professionals as part of the multidisciplinary obesity and bariatric care program. Receives: Behavioral: Adapted Physical Activity |
| Adapted Physical Activity + Dramatherapy | Other | Participants allocated to the experimental group will receive the standard adapted physical activity (APA) program combined with a complementary dramatherapy intervention. In addition to the 12 supervised APA sessions delivered over 6 weeks, participants will take part in weekly group dramatherapy sessions led by a qualified art therapist. The intervention includes 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, psychosocial well-being, and long-term adherence to care. Receives: Behavioral: Adapted Physical Activity; Behavioral: Dramatherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change 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.
Measured: Baseline and end of care 6 weeks, 6 months, 12 months
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, end of care approximately 6 weeks, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start30 Jun 2026
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a monocentric randomized controlled parallel-group study comparing a standardized adapted physical activity (APA) program alone versus APA combined with dramatherapy (DT) in adult patients with obesity enrolled in medical or bariatric care pathways. Randomization is stratified according to care pathway type (medical versus bariatric). Participants are followed longitudinally with assessments conducted at baseline, at the end of care, and at 6- and 12-month follow-up.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universite du Littoral Cote d'Opale
- Sponsor type
- University, hospital or other
- Collaborators
- ELSAN Clinic in Saint Omer, France
- Responsible party
- Sponsor
- Investigators
- Alessandro Porrrovecchio, PhD HDR, Principal investigator, Université du Littoral Cote d'OpaleMorgane Carton, Principal investigator, ELSAN Clinic in Saint OmerAriane Martinez, Full Professor, Principal investigator, Lille University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685483
- Sponsor's protocol ID
- 2025-A02244-45
- Status last verified
- Jul 2026
- First submitted
- 27 May 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07685483
- Acronym / sponsor ID
- 2025-A02244-45
- Keywords
- Obesity, Eating Disorders, Bariatric Surgery, Dramatherapy, Art Therapy, Adapted Physical Activity, Body image, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Universite du Littoral Cote d'OpaleUniversity, hospital or other
- Collaborators
- ELSAN Clinic in Saint Omer, France
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Standardized adapted physical activity alone (control group);
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a monocentric randomized controlled parallel-group study comparing a standardized adapted physical activity (APA) program alone versus APA combined with dramatherapy (DT) in adult patients with obesity enrolled in medical or bariatric care pathways. Randomization is stratified according to care pathway type (medical versus bariatric). Participants are followed longitudinally with assessments conducted at baseline, at the end of care, and at 6- and 12-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Adapted Physical Activity | Active comparator | Behavioral: Adapted Physical ActivityParticipants allocated to the control group will receive the standard adapted physical activity (APA) program routinely implemented within the obesity care pathway. The intervention consists of 12 supervised sessions over 6 weeks, including cardiovascular exercises, muscle strengthening, and progressive movement activities adapted to the physical capacities and clinical condition of patients with obesity. Sessions are delivered by qualified APA professionals as part of the multidisciplinary obesity and bariatric care program. |
| Adapted Physical Activity + Dramatherapy | Other | Behavioral: Adapted Physical Activity, Behavioral: DramatherapyParticipants allocated to the experimental group will receive the standard adapted physical activity (APA) program combined with a complementary dramatherapy intervention. In addition to the 12 supervised APA sessions delivered over 6 weeks, participants will take part in weekly group dramatherapy sessions led by a qualified art therapist. The intervention includes 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, psychosocial well-being, and long-term adherence to care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Physical ActivityStandardized 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. | Behavioural | Adapted Physical Activity, Adapted Physical Activity + Dramatherapy |
| DramatherapyGroup 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. | Behavioural | Adapted Physical Activity + Dramatherapy |
Primary outcome
Change in Quality of Life Assessed by the Échelle Qualité de Vie, Obésité et Diététique / Quality of Life, Obesity and Dietetics Global Score
Time frame: 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.
10 secondary outcomes
Change in Eating Disorder Screening Score Assessed by the SCOFF Questionnaire
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
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
Time frame: Baseline, end of care (6 weeks), 6 months, and 12 months
Change in Self-Efficacy Assessed by the General Self-Efficacy Scale
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
Time frame: Baseline, end of care (6 weeks), 6 months, and 12 months
Adherence to Adapted Physical Activity Assessed by Attendance Rate
Time frame: During the 6 week period
Change in Body Mass Index
Time frame: Baseline, end of care (6 weeks), 6 months, and 12 months
Change in Body Weight
Time frame: Baseline, end of care approximately 6 weeks, 6 months, and 12 months
Change in Abdominal Circumference
Time frame: Baseline, end of care approximately 6 weeks, 6 months, and 12 months
Change in Body Composition Assessed by Bioimpedance Analysis
Time frame: Baseline, end of care approximately 6 weeks, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alessandro Porrrovecchio, PhD HDR principal investigator
Université du Littoral Cote d'Opale
Morgane Carton principal investigator
ELSAN Clinic in Saint Omer
Ariane Martinez, Full Professor principal investigator
Lille University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Physical Activity and Dramatherapy in people with Obesity (Disorder) and Obesity & Overweight, run by Universite du Littoral Cote d'Opale at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Porrovecchio, PhD HDR (0033647120423, alessandro.porrovecchio@univ-littoral.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life Assessed by the Échelle Qualité de Vie, Obésité et Diététique / Quality of Life, Obesity and Dietetics Global Score (time frame: Baseline and end of care 6 weeks, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.