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

Obesity Clinical Trial

— APHYNET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05249998
• Other study ID #: APHP200143
• Status: Recruiting
• Phase: N/A
• Start date: November 6, 2021
• Est. completion date: April 2024

Study information

• Verified date: April 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Hélène PASTRE
• Phone: 05 59 48 08 00
• Email: helene.pastre[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 :

1. The evolution of physical capacities,

2. The evolution of metabolic criteria and metabolic and cardio-respiratory risk factors,

3. The evolution of eating behaviour,

4. Adherence to the program during hospitalization.

At 3 and 6 months after hospitalization :

Evaluate the impact of the intervention on :

1. The evolution of weekly physical activity at home,

2. The evolution of eating behaviour at home,

3. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: April 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity
• Prader-Willi Syndrome
• Syndrome

Intervention

Other:
• Program combing APA, Nutrition, and Therapeutic Education
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.

Locations

Country	Name	City	State
France	Service diététique Hôpital Marin d'Hendaye- AP-HP	Hendaye

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Mass Index (BMI)		week 4
Primary	Change in Body Mass Index (BMI)		week 7
Secondary	six minute walking test (6MWT)		week 4
Secondary	Forced Vital Capacity		baseline and week 4
Secondary	Maximum Volume Expired in the 1st Second		baseline and week 4
Secondary	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	baseline and week 4
Secondary	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	baseline and week 4
Secondary	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	baseline and week 4
Secondary	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	baseline and week 4
Secondary	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	baseline and week 4
Secondary	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	baseline and week 4
Secondary	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	baseline and week 4
Secondary	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	baseline and week 4
Secondary	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	baseline and week 4
Secondary	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	baseline and week 4
Secondary	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	baseline and week 4
Secondary	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	baseline and week 4
Secondary	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.	baseline and week 4
Secondary	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.	baseline and week 4
Secondary	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"	baseline, Month 4, Month 7
Secondary	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.	baseline, Month 4, Month 7
Secondary	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	baseline, Month 4, Month 7
Secondary	Weight		Month 2, Month 3, Month 4, Month 5, Month 6, Month 7