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New treatment option for Obesity (Disorder)
Official title Dramatherapy for Psychological and Social Well-Being in Obesity and Bariatric Care
ClinicalTrials.gov ID: NCT07685483
What this study is testing
- What it's testing
- 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.
- Time commitment: about 6 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Enrollment in a medical or bariatric care pathway at the Institut de l'Obésité, Clinique ELSAN Saint-Omer, including a therapeutic education program...
- Availability and willingness to complete the planned study procedures and follow-up assessments.
- Written informed consent provided after complete information about the study.
You likely can't join if
- Major medical contraindications to adapted physical activity or group sessions, including unstable cardiovascular disease or severe non-compensable...
- Severe psychiatric disorders or severe unstable eating disorders contraindicating bariatric surgery or preventing adequate participation in group...
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Blendecques, Hauts-de-France, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Blendecques, Hauts-de-France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.