search
Back to results

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

Primary Purpose

Prader-Willi Syndrome, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Program combing APA, Nutrition, and Therapeutic Education
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prader-Willi Syndrome focused on measuring Prader Willi Syndrome, Therapeutic Education, Adapted Physical Activity, Nutrition

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventional group

Standard care group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Body Mass Index (BMI)
Change in Body Mass Index (BMI)

Secondary Outcome Measures

six minute walking test (6MWT)
Forced Vital Capacity
Maximum Volume Expired in the 1st Second
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
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
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
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
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
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
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
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
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
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
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
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
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.
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.
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"
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.
Goal Attainment Scaling
This scale aims to help the participant to set up a regular walk to reduce sedentary lifestyle. The participant can put the amount of physical activity he does daily. The investigators can then attribute 5 scores which are : 2 for "no activity", this is the minimum and worst score 1 for "walking at least 30 minutes 1 time per week" 0 for "walking at least 30 minutes 3 times per week" 1 for "walking at least 30 minutes every day" 2 for "walking at least 1 hour every day", this is the goal and the maximum and best score
Weight

Full Information

First Posted
October 15, 2021
Last Updated
April 11, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
search

1. Study Identification

Unique Protocol Identification Number
NCT05249998
Brief Title
Improving Care of Prader-Willi Syndrome : Evaluation of a New Care Program Combining Adapted Physical Activity, Nutrition and Therapeutic Education
Acronym
APHYNET
Official Title
Improving Care of Prader-Willi Syndrome : Evaluation of a New Care Program Combining Adapted Physical Activity, Nutrition and Therapeutic Education
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 6, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prader-Willi Syndrome, Obesity
Keywords
Prader Willi Syndrome, Therapeutic Education, Adapted Physical Activity, Nutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Program combing APA, Nutrition, and Therapeutic Education
Intervention Description
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 Outcome Measure Information:
Title
Change in Body Mass Index (BMI)
Time Frame
week 4
Title
Change in Body Mass Index (BMI)
Time Frame
week 7
Secondary Outcome Measure Information:
Title
six minute walking test (6MWT)
Time Frame
week 4
Title
Forced Vital Capacity
Time Frame
baseline and week 4
Title
Maximum Volume Expired in the 1st Second
Time Frame
baseline and week 4
Title
Prospective assessment of clinical features before and after Adapted Physical Activity Program
Description
Weight in kilograms, Height in meters to calculate Body Mass Index (BMI) in kg/m^2
Time Frame
baseline and week 4
Title
Difference of CRP dosage between before and after Adapted Physical Activity Program
Description
CRP measured before and after Adapted Physical Activity Program : difference between these two dosages
Time Frame
baseline and week 4
Title
Difference of Glycated hemoglobin (Hba1C) between before and after Adapted Physical Activity Program
Description
Glycated hemoglobin (Hba1C) measured before and after Adapted Physical Activity Program : difference between these two dosages
Time Frame
baseline and week 4
Title
Difference of fasting blood glucose between before and after Adapted Physical Activity Program
Description
fasting blood glucose level measured before and after Adapted Physical Activity Program : difference between these two dosages
Time Frame
baseline and week 4
Title
Difference of cholesterol between before and after Adapted Physical Activity Program
Description
Cholesterol measured before and after Adapted Physical Activity Program : difference between these two dosages
Time Frame
baseline and week 4
Title
Difference of Glycemy between before and after Adapted Physical Activity Program
Description
Glycemy measured before and after Adapted Physical Activity Program : difference between these two dosages
Time Frame
baseline and week 4
Title
Difference of transaminases between before and after Adapted Physical Activity Program
Description
Transaminases measured before and after Adapted Physical Activity Program : difference between these two dosages
Time Frame
baseline and week 4
Title
Difference of Gamma GT between before and after Adapted Physical Activity Program
Description
Gamma GT measured before and after Adapted Physical Activity Program : difference between these two dosages
Time Frame
baseline and week 4
Title
Difference of Alkaline phosphatase between before and after Adapted Physical Activity Program
Description
Alkaline phosphatase measured before and after Adapted Physical Activity Program : difference between these two dosages
Time Frame
baseline and week 4
Title
Difference of urea between before and after Adapted Physical Activity Program
Description
Urea measured before and after Adapted Physical Activity Program : difference between these two dosages
Time Frame
baseline and week 4
Title
Difference of creatinine between before and after Adapted Physical Activity Program
Description
creatinine measured before and after Adapted Physical Activity Program : difference between these two dosages
Time Frame
baseline and week 4
Title
Difference of albumin between before and after Adapted Physical Activity Program
Description
albumin measured before and after Adapted Physical Activity Program : difference between these two dosages
Time Frame
baseline and week 4
Title
RELIME : REal LIfe Meal Evaluation score
Description
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.
Time Frame
baseline and week 4
Title
Adhesion Grid Scores
Description
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.
Time Frame
baseline and week 4
Title
Ricci & Gagnon self-questionnaire
Description
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"
Time Frame
baseline, Month 4, Month 7
Title
Hyperphagia Questionnaire
Description
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.
Time Frame
baseline, Month 4, Month 7
Title
Goal Attainment Scaling
Description
This scale aims to help the participant to set up a regular walk to reduce sedentary lifestyle. The participant can put the amount of physical activity he does daily. The investigators can then attribute 5 scores which are : 2 for "no activity", this is the minimum and worst score 1 for "walking at least 30 minutes 1 time per week" 0 for "walking at least 30 minutes 3 times per week" 1 for "walking at least 30 minutes every day" 2 for "walking at least 1 hour every day", this is the goal and the maximum and best score
Time Frame
baseline, Month 4, Month 7
Title
Weight
Time Frame
Month 2, Month 3, Month 4, Month 5, Month 6, Month 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hélène PASTRE
Phone
05 59 48 08 00
Email
helene.pastre@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Virginie LAURIER
Phone
05 59 48 08 21
Email
virginie.laurier@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélène PASTRE
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service diététique Hôpital Marin d'Hendaye- AP-HP
City
Hendaye
ZIP/Postal Code
64701
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène PASTRE
Phone
05 59 48 08 00
Email
helene.pastre@aphp.fr
First Name & Middle Initial & Last Name & Degree
Virginie LAURIER
Phone
05 59 48 08 21
Email
virginie.laurier@aphp.fr

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs