Dramatherapy Added to Physical Activity for Obesity Care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This monocentric randomized trial enrolls adults with obesity who are in medical or bariatric care at Clinique Elsan Saint-Omer. Participants are assigned to receive either dramaturapy in addition to a standardized adapted physical activity program or the standard program alone. The study examines effects on psychological and social well‑being, body image, emotional regulation, and adherence to lifestyle changes over follow-up assessments. Interventions focus on integrating psychological and psychosocial support with medical and nutritional care within existing care pathways. The trial is led by Université du Littoral Côte d’Opale and conducted at the Saint-Omer site in Hauts-de-France.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clinique Elsan de Saint Omer
  Blendecques, Hauts-de-France, France Recruiting

Study contacts

• Principal investigator: Alessandro Porrrovecchio, PhD HDR — Université du Littoral Cote d'Opale
• Study coordinator: Alessandro Porrovecchio, PhD HDR
• Email: alessandro.porrovecchio@univ-littoral.fr
• Phone: 0033647120423

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.