NCT05249998Completed
Improving Care of Prader-Willi Syndrome : Evaluation of a New Care Program Combining Adapted Physical Activity, Nutrition and Therapeutic Education
Source: ClinicalTrials.gov · Last updated 3 Oct 2025
Brief summary (registry, in English)
Prader-Willi syndrome (PWS) is a rare and complex genetic disease characterized by hypothalamic-pituitary axis dysfunction combining eating disorders associated with hyperphagia and satiety deficiency, mild intellectual deficit and behavioral disorders. This disease requires continuous management through specific therapeutic education to prevent metabolic and cardiorespiratory complications related to obesity. Physical activity must therefore be regular, adapted to the disability, taking into account cognitive deficits and behavioral disorders. The Unit of Care and Rehabilitation, of the Hôpital Marin d'Hendaye, receives patients with PWS or other obesity from rare causes, at a rate of 1 to 2 annual stays of 1 to 2 months, which allow the regulation of somatic disorders and the initiation of weight loss. However, the difficulty is to keep a stable weight curve between stays. Only 20% of patients over the last 2 years managed to stabilize or decrease their BMI during the 6 months following their hospitalization. The proposed study aims to evaluate an innovative and individualized care program combining Physical activity, Nutrition and therapeutic education for adults with PWS who will be admitted to the hospital for 5 weeks. We hypothesize that this program will allow to stabilize or decrease the BMI of patients at 6 months after hospitalization by inducing a behavioral change in terms of physical activity and eating behavior. We will conduct a randomized controlled trial on 128 patients who will participate in this program, or will benefit from standard care.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 128 (actual)
- First submitted
- 15 Oct 2021
- Start date
- 6 Nov 2021
- Primary completion date
- 4 May 2024
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Obesity
- NCT number
- NCT05249998
What you commit to
- Study type: Interventional
- Participants enrolled: 128
- From 6 Nov 2021 to the primary completion date, 4 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Decompensation of a cardiorespiratory or psychiatric pathology in the 3 months prior to inclusion that required hospitalisation
Other illness
- Patients whose condition may interfere with their optimal participation in the study (e.g., severe behavioural problems preventing participation in group workshops)
Who the study is looking for
- Patient between 18 and 60 years old Patient with genetically confirmed PWS
- Admitted for a 5-week stay in the Hendaye rehabilitation care unit
- Patient or legal guardian (tutor or curator) who has given written informed consent to participate in the study
- With the presence of an external relay available to coordinate the patient's journey during the protocol: family or educational referent (home)
- Affiliated with French social security except patient under AME (State medical aid)
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service diététique Hôpital Marin d'Hendaye- AP-HP Coordinator of this site? Confirm its status | Hendaye | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.