Prader-Willi SyndromeAPHYNETNCT05249998
Improving Care of Prader-Willi Syndrome : Evaluation of a New Care Program Combining Adapted Physical Activity, Nutrition and Therapeutic Education
A study testing Program combing APA, Nutrition, and Therapeutic Education in people with Prader-Willi Syndrome and Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Prader-Willi Syndrome, Obesity
- What is being tested?
- Program combing APA, Nutrition, and Therapeutic Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2021to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
Main objective :
Evaluate the effectiveness at 6 months of an intensified and individualised care programme combining theoretical and practical therapeutic education workshops on adapted physical activity, nutrition and eating behaviour (i.e. intervention) during hospitalisation, compared to usual care (i.e. control).
The assessment will be done by comparing the proportion of patients stabilizing or decreasing their BMI at 6 months after the end of the stay (M7) in the 2 groups (intervention/control).
Secondary objectives:
During hospitalization:
To evaluate, compared to the usual care, the impact of the intervention on :
- The evolution of physical capacities,
- The evolution of metabolic criteria and metabolic and cardio-respiratory risk factors,
- The evolution of eating behaviour,
- Adherence to the program during hospitalization.
At 3 and 6 months after hospitalization :
Evaluate the impact of the intervention on :
- The evolution of weekly physical activity at home,
- The evolution of eating behaviour at home,
- Reaching the personalized objective set for the inter-stay.
At 6 months after hospitalization:
Evaluate, in comparison with the usual management, the impact of the intervention on the evolution of metabolic criteria and metabolic and cardio-respiratory risk factors during a consultation at the hospital in their reference center.
- Conditions
- Prader-Willi Syndrome, Obesity
- Being tested
- Program combing APA, Nutrition, and Therapeutic Education
- Keywords
- Prader Willi Syndrome, Therapeutic Education, Adapted Physical Activity, Nutrition
- Medical subject headings
- Prader-Willi Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program combing APA, Nutrition, and Therapeutic EducationOther
Patients will benefit from the activities already proposed as part of the usual practice and in addition a multidisciplinary staff will take place in order to interpret the assessments of the patients included and to direct the patients according to their phenotypic profile towards the different programmes of adapted physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Patients will receive the usual care, with the intervention of the multidisciplinary team which defines with the patient the objectives of the stay and the inter-stay period, without "specific therapeutic education" on adapted physical activity, nutrition and eating behaviour. Receives: Other: Program combing APA, Nutrition, and Therapeutic Education |
| Standard care group | No intervention | Patients will benefit from the activities already proposed as part of the usual practice and in addition a multidisciplinary staff will take place in order to interpret the assessments of the patients included and to direct the patients according to their phenotypic profile towards the different programmes of adapted physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index (BMI)
Measured: week 4
Change in Body Mass Index (BMI)
Measured: week 7
Secondary outcomes (21)
six minute walking test (6MWT)
Measured: week 4
Forced Vital Capacity
Measured: baseline and week 4
Maximum Volume Expired in the 1st Second
Measured: baseline and week 4
Prospective assessment of clinical features before and after Adapted Physical Activity Program
Weight in kilograms, Height in meters to calculate Body Mass Index (BMI) in kg/m^2
Measured: baseline and week 4
Difference of CRP dosage between before and after Adapted Physical Activity Program
CRP measured before and after Adapted Physical Activity Program : difference between these two dosages
Measured: baseline and week 4
Difference of Glycated hemoglobin (Hba1C) between before and after Adapted Physical Activity Program
Glycated hemoglobin (Hba1C) measured before and after Adapted Physical Activity Program : difference between these two dosages
Measured: baseline and week 4
Difference of fasting blood glucose between before and after Adapted Physical Activity Program
fasting blood glucose level measured before and after Adapted Physical Activity Program : difference between these two dosages
Measured: baseline and week 4
Difference of cholesterol between before and after Adapted Physical Activity Program
Cholesterol measured before and after Adapted Physical Activity Program : difference between these two dosages
Measured: baseline and week 4
Difference of Glycemy between before and after Adapted Physical Activity Program
Glycemy measured before and after Adapted Physical Activity Program : difference between these two dosages
Measured: baseline and week 4
Difference of transaminases between before and after Adapted Physical Activity Program
Transaminases measured before and after Adapted Physical Activity Program : difference between these two dosages
Measured: baseline and week 4
Difference of Gamma GT between before and after Adapted Physical Activity Program
Gamma GT measured before and after Adapted Physical Activity Program : difference between these two dosages
Measured: baseline and week 4
Difference of Alkaline phosphatase between before and after Adapted Physical Activity Program
Alkaline phosphatase measured before and after Adapted Physical Activity Program : difference between these two dosages
Measured: baseline and week 4
Difference of urea between before and after Adapted Physical Activity Program
Urea measured before and after Adapted Physical Activity Program : difference between these two dosages
Measured: baseline and week 4
Difference of creatinine between before and after Adapted Physical Activity Program
creatinine measured before and after Adapted Physical Activity Program : difference between these two dosages
Measured: baseline and week 4
Difference of albumin between before and after Adapted Physical Activity Program
albumin measured before and after Adapted Physical Activity Program : difference between these two dosages
Measured: baseline and week 4
RELIME : REal LIfe Meal Evaluation score
This score is devided in 3 under-scores which are:
- "eating behavior score" scale of 0 to 30
- "general behavior score" scale of 0 to 20
- "social behavior score" scale of 0 to 16 The final score is on a scale of 0 to 66. 0 is the minimum and the best score. 66 is the maximum and worst score.
Measured: baseline and week 4
Adhesion Grid Scores
This score is devided in 2 scores which are :
"adhesion" on a scale of 0 to 2 "motivation" on a scale of 0 to 2
The final score is the addition of them on a scale of 0 to 4. The minimum and worst score is 0. The maximum and best score is 4.
Measured: baseline and week 4
Ricci & Gagnon self-questionnaire
This score is on a scale of 0 to 45, 0 is the minimum and worst score and 45 the maximum and worst score of physical activity.
Score under 18 means "inactive" Score between 18 and 35 means "active" Score superior to 35 means "very active"
Measured: baseline, Month 4, Month 7
Hyperphagia Questionnaire
This score is devided in 3 under-scores which are :
- "hyperphagic behavior" score on a scale of 5 to 25
- "hyperphagic drive" score on a scale of 4 to 20
- "hyperphagic severity" score on a scale of 2 to 10 The final score is on a scale of 11 to 55. 11 is the minimum and best score. 55 is the maximum and worst score.
Measured: baseline, Month 4, Month 7
Goal Attainment Scaling
Goal Attainment Scaling (GAS) is a method for writting personalized evaluation scales in order to quantify progress towards defined goals.
The GAS methodology consists of:
- defining an rehabilitation goal with the patient
- choosing an observable behavior that reflects the degree of goal attainment
- assessing the patient's initial level (pre- intervention) with respect to the goal
- defining five goal attainment levels , ranging from "no change" (-2) to "a much better than expected outcome" (+2)
- Evaluating the patient after the set time frame and determine the GAS score between -2 and +2
A five point scale is used :
" -2 " is the baseline ; " -1 " represents progression to the goal without goal attainment ; " 0 " is the expected level after intervention ; " +1 " is represent a better outcome than expected ; " +2 " is the best possible outcometha t could have been expected to the goal
Scores between " 0 " and " +2 " indicate that the patient has achieved the objective
Measured: baseline, Month 4, Month 7
Weight
Measured: Month 2, Month 3, Month 4, Month 5, Month 6, Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start6 Nov 2021
- Primary completion4 May 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prader-Willi SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène PASTRE, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249998
- Sponsor's protocol ID
- APHP200143
- Acronym
- APHYNET
- Status last verified
- Sep 2025
- First submitted
- 15 Oct 2021
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care of Prader-Willi Syndrome : Evaluation of a New Care Program Combining Adapted Physical Activity, Nutrition and Therapeutic Education
- ClinicalTrials.gov ID
- NCT05249998
- Acronym / sponsor ID
- APHYNET / APHP200143
- Conditions
- Prader-Willi Syndrome, Obesity
- Keywords
- Prader Willi Syndrome, Therapeutic Education, Adapted Physical Activity, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 6 Nov 2021 (actual)
- Primary completion
- 4 May 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 22 Feb 2022 (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.
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.
Detailed description
Main objective :
Evaluate the effectiveness at 6 months of an intensified and individualised care programme combining theoretical and practical therapeutic education workshops on adapted physical activity, nutrition and eating behaviour (i.e. intervention) during hospitalisation, compared to usual care (i.e. control).
The assessment will be done by comparing the proportion of patients stabilizing or decreasing their BMI at 6 months after the end of the stay (M7) in the 2 groups (intervention/control).
Secondary objectives:
During hospitalization:
To evaluate, compared to the usual care, the impact of the intervention on :
- The evolution of physical capacities,
- The evolution of metabolic criteria and metabolic and cardio-respiratory risk factors,
- The evolution of eating behaviour,
- Adherence to the program during hospitalization.
At 3 and 6 months after hospitalization :
Evaluate the impact of the intervention on :
- The evolution of weekly physical activity at home,
- The evolution of eating behaviour at home,
- Reaching the personalized objective set for the inter-stay.
At 6 months after hospitalization:
Evaluate, in comparison with the usual management, the impact of the intervention on the evolution of metabolic criteria and metabolic and cardio-respiratory risk factors during a consultation at the hospital in their reference center.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: Program combing APA, Nutrition, and Therapeutic EducationPatients will receive the usual care, with the intervention of the multidisciplinary team which defines with the patient the objectives of the stay and the inter-stay period, without "specific therapeutic education" on adapted physical activity, nutrition and eating behaviour. |
| Standard care group | No intervention | –Patients will benefit from the activities already proposed as part of the usual practice and in addition a multidisciplinary staff will take place in order to interpret the assessments of the patients included and to direct the patients according to their phenotypic profile towards the different programmes of adapted physical activity. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- 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)
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 |
|---|---|---|
| Program combing APA, Nutrition, and Therapeutic EducationPatients will benefit from the activities already proposed as part of the usual practice and in addition a multidisciplinary staff will take place in order to interpret the assessments of the patients included and to direct the patients according to their phenotypic profile towards the different programmes of adapted physical activity. | Other | Interventional group |
Primary outcome
Change in Body Mass Index (BMI)
Time frame: week 4
Change in Body Mass Index (BMI)
Time frame: week 7
21 secondary outcomes
six minute walking test (6MWT)
Time frame: week 4
Forced Vital Capacity
Time frame: baseline and week 4
Maximum Volume Expired in the 1st Second
Time frame: baseline and week 4
Prospective assessment of clinical features before and after Adapted Physical Activity Program
Time frame: baseline and week 4
Difference of CRP dosage between before and after Adapted Physical Activity Program
Time frame: baseline and week 4
Difference of Glycated hemoglobin (Hba1C) between before and after Adapted Physical Activity Program
Time frame: baseline and week 4
Difference of fasting blood glucose between before and after Adapted Physical Activity Program
Time frame: baseline and week 4
Difference of cholesterol between before and after Adapted Physical Activity Program
Time frame: baseline and week 4
Difference of Glycemy between before and after Adapted Physical Activity Program
Time frame: baseline and week 4
Difference of transaminases between before and after Adapted Physical Activity Program
Time frame: baseline and week 4
Difference of Gamma GT between before and after Adapted Physical Activity Program
Time frame: baseline and week 4
Difference of Alkaline phosphatase between before and after Adapted Physical Activity Program
Time frame: baseline and week 4
Difference of urea between before and after Adapted Physical Activity Program
Time frame: baseline and week 4
Difference of creatinine between before and after Adapted Physical Activity Program
Time frame: baseline and week 4
Difference of albumin between before and after Adapted Physical Activity Program
Time frame: baseline and week 4
RELIME : REal LIfe Meal Evaluation score
Time frame: baseline and week 4
Adhesion Grid Scores
Time frame: baseline and week 4
Ricci & Gagnon self-questionnaire
Time frame: baseline, Month 4, Month 7
Hyperphagia Questionnaire
Time frame: baseline, Month 4, Month 7
Goal Attainment Scaling
Time frame: baseline, Month 4, Month 7
Weight
Time frame: Month 2, Month 3, Month 4, Month 5, Month 6, Month 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Hélène PASTRE principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program combing APA, Nutrition, and Therapeutic Education in people with Prader-Willi Syndrome and Obesity, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 3 Oct 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (BMI) (time frame: week 4). The study lists 2 primary outcomes in all. 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 3 Oct 2025.