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New lifestyle program aims to help Prader-Willi patients keep weight off

NCT ID NCT05249998

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed trial tested a personalized program of physical activity, nutrition guidance, and education for 128 adults with Prader-Willi syndrome. Participants followed the program during a 5-week hospital stay, with the goal of stabilizing or reducing their body mass index (BMI) six months later. The study compared this new approach to standard care to see if it could help patients maintain healthier habits after returning home.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a care program combining adapted physical activity, nutrition, and therapeutic education
What this could lead to
If successful, this program could help adults with Prader-Willi syndrome maintain a healthier weight and improve their physical fitness and quality of life between hospital stays.
What could go wrong
This is a single completed trial with 128 participants, so results may not apply to everyone. The program requires significant support from family or caregivers, which may not be available for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

128 people

The number who actually took part.

Started

Nov 2021

Finished

Nov 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) Exclusion Criteria: * Decompensation of a cardiorespiratory or psychiatric pathology in the 3 months prior to inclusion that required hospitalisation * Patients whose condition may interfere with their optimal participation in the study (e.g., severe behavioural problems preventing participation in group workshops)

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Prader-Willi syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity Prader-Willi syndrome

Contacts and locations

Locations

  • Service diététique Hôpital Marin d'Hendaye- AP-HP

    Hendaye, 64701, France

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