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Completed

NCT Number: NCT05249998

Improving Care of Prader-Willi Syndrome : Evaluation of a New Care Program Combining Adapted Physical Activity, Nutrition and Therapeutic Education

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.

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Key information

Conditions

Prader-Willi Syndrome Abnormalities, Multiple Body Weight Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Imprinting Disorders Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service diététique Hôpital Marin d'Hendaye- AP-HP

Hendaye, 64701, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Program combing APA, Nutrition, and Therapeutic Education

Other

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.

Primary outcomes

  1. Change in Body Mass Index (BMI)

    Time frame: week 4

  2. Change in Body Mass Index (BMI)

    Time frame: week 7

Secondary outcomes

  1. six minute walking test (6MWT)

    Time frame: week 4

  2. Forced Vital Capacity

    Time frame: baseline and week 4

  3. Maximum Volume Expired in the 1st Second

    Time frame: baseline and week 4

  4. Prospective assessment of clinical features before and after Adapted Physical Activity Program

    Time frame: baseline and week 4

    Weight in kilograms, Height in meters to calculate Body Mass Index (BMI) in kg/m^2

  5. Difference of CRP dosage between before and after Adapted Physical Activity Program

    Time frame: baseline and week 4

    CRP measured before and after Adapted Physical Activity Program : difference between these two dosages

  6. Difference of Glycated hemoglobin (Hba1C) between before and after Adapted Physical Activity Program

    Time frame: baseline and week 4

    Glycated hemoglobin (Hba1C) measured before and after Adapted Physical Activity Program : difference between these two dosages

  7. Difference of fasting blood glucose between before and after Adapted Physical Activity Program

    Time frame: baseline and week 4

    fasting blood glucose level measured before and after Adapted Physical Activity Program : difference between these two dosages

  8. Difference of cholesterol between before and after Adapted Physical Activity Program

    Time frame: baseline and week 4

    Cholesterol measured before and after Adapted Physical Activity Program : difference between these two dosages

  9. Difference of Glycemy between before and after Adapted Physical Activity Program

    Time frame: baseline and week 4

    Glycemy measured before and after Adapted Physical Activity Program : difference between these two dosages

  10. Difference of transaminases between before and after Adapted Physical Activity Program

    Time frame: baseline and week 4

    Transaminases measured before and after Adapted Physical Activity Program : difference between these two dosages

  11. Difference of Gamma GT between before and after Adapted Physical Activity Program

    Time frame: baseline and week 4

    Gamma GT measured before and after Adapted Physical Activity Program : difference between these two dosages

  12. Difference of Alkaline phosphatase between before and after Adapted Physical Activity Program

    Time frame: baseline and week 4

    Alkaline phosphatase measured before and after Adapted Physical Activity Program : difference between these two dosages

  13. Difference of urea between before and after Adapted Physical Activity Program

    Time frame: baseline and week 4

    Urea measured before and after Adapted Physical Activity Program : difference between these two dosages

  14. Difference of creatinine between before and after Adapted Physical Activity Program

    Time frame: baseline and week 4

    creatinine measured before and after Adapted Physical Activity Program : difference between these two dosages

  15. Difference of albumin between before and after Adapted Physical Activity Program

    Time frame: baseline and week 4

    albumin measured before and after Adapted Physical Activity Program : difference between these two dosages

  16. RELIME : REal LIfe Meal Evaluation score

    Time frame: baseline and week 4

    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.

  17. Adhesion Grid Scores

    Time frame: baseline and week 4

    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.

  18. Ricci & Gagnon self-questionnaire

    Time frame: baseline, Month 4, Month 7

    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"

  19. Hyperphagia Questionnaire

    Time frame: baseline, Month 4, Month 7

    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.

  20. Goal Attainment Scaling

    Time frame: baseline, Month 4, Month 7

    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

  21. Weight

    Time frame: Month 2, Month 3, Month 4, Month 5, Month 6, Month 7

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: APHYNET

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 22, 2022
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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