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

NCT05249998 | Completed

• 1 other identifier: APHP200143
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Prader-Willi Syndrome; Obesity

Keywords

Prader Willi Syndrome; Therapeutic Education; Adapted Physical Activity; Nutrition

Outcome Measures

Primary Outcomes (2)

• Change in Body Mass Index (BMI)

  week 4

• Change in Body Mass Index (BMI)

  week 7

Secondary Outcomes (21)

• six minute walking test (6MWT)

  week 4

• Forced Vital Capacity

  baseline and week 4

• Maximum Volume Expired in the 1st Second

  baseline and week 4

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

  baseline and week 4

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

  baseline and week 4

Study Arms (2)

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.

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.

Interventions

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.

Interventional group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Patients whose condition may interfere with their optimal participation in the study (e.g., severe behavioural problems preventing participation in group workshops)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service diététique Hôpital Marin d'Hendaye- AP-HP

Hendaye, 64701, France

Location

MeSH Terms

Conditions

Prader-Willi Syndrome; Obesity

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Hélène PASTRE

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: February 22, 2022
• Study Start: November 6, 2021
• Primary Completion: May 4, 2024
• Study Completion: November 15, 2024
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)