He-move-philia, Lifestyle Intervention for Patients With Hemophilia

Study Overview
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Brief Summary
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The main objectives are reduction of body weight, BMI and abdominal circumference. Secondary objectives are reduction of bleeds and units coagulation factor concentrate used, blood-pressure, cholesterol spectrum, glucose and improvement of physical activity and dietary habits. one group of patients will receive a combined lifestyle intervention program with individual sessions and group sessions lasting for 2 years, the other group of patients will receive individual sessions only and will be given the same information as given in the group sessions, but on paper.

Detailed Description
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The prevalence of overweight and obesity is increasing in patients with hemophilia and other bleeding disorders. In these patients physical activity is often difficult due to arthropathy as a result of intra-articular bleeding in the past, with decreased joint movement and pain and the fear of new bleeds. This enhances weight gain, increases pressure on joints, leading to more bleeds and more arthropathy. In the long term overweight and obesity increases risk of cardiovascular diseases, with the concomitant need for anticoagulant therapy, which further enhances the bleeding risk in these patients. The aim of this exploratory study is to compare the effect of a lifestyle intervention program consisting of combined individual coaching and group sessions (CLI) with a lifestyle intervention program with individual coaching only (II).The program is especially designed for patients with a bleeding disorder. The investigators hypothesize that body weight, BMI, abdominal circumference, bleeds and units coagulation factor concentrate, as these are dosed on body weight, will decrease in both groups, but more in the CLI with group sessions.

Official Title
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He-move-philia, a Combined Lifestyle Intervention Program for Patients With Hemophilia and Other Bleeding Disorders

Conditions
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Hemophilia

Intervention / Treatment
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* Other: Lifestyle - group sessions
* Other: Lifestyle - individual coaching


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Diagnosed with hemophilia A, B, FVII deficiency, fibrinogen deficiency, von Willebrand Disease or other bleeding disorder preferably requiring coagulation products for prophylaxis or on demand in case of bleeding ≥ 18 years of age BMI ≥ 30 kg/m2 Motivated to change their lifestyle Being able to speak, read and understand the Dutch language Exclusion criteria Health care insurance with CZ or ONVZ as these health insurances have no contract with Profitt Lifestylecoaching. A contraindication or inability for physical activity as judged by the treating hemophilia physician Participation in another research trial Unable to understand the written information Unable to sign the informed consent Unwilling to randomize to the combined or individual intervention group

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Combined intervention<br>The Combined Lifestyle Intervention Program consists of a total of 7 individual coaching sessions and 16 group sessions in a 2 year program. The individual coaching sessions will be done in a virtual setting | Other: Lifestyle - group sessions<br>* The Combined Lifestyle Intervention Program consists of a total of 7 individual coaching sessions and 16 group sessions in a 2 year program. The individual coaching sessions will be done in a virtual setting.<br>|
| Active Comparator: individual intervention<br>The Individual Intervention consists of a total of 7 individual coaching sessions in a 2 year program and additional written information. These will be done in a virtual setting | Other: Lifestyle - individual coaching<br>* The Individual Intervention consists of a total of 7 individual coaching sessions in a 2 year program and additional written information. These will be done in a virtual setting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| kg | The main study parameter is body weight in kg. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal circumference (cm) |  | 36 months | 
| Number of spontaneous bleeds |  | 36 months | 
| Number of induced bleeds |  | 36 months | 
| Units coagulation factor concentrate used/year (IU) |  | 36 months | 
| Blood-pressurre (mm Hg) |  | 36 months | 
| Cholesterol spectrum | including: total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol (mmol/l), all in non-fasting state | 36 months | 
| Glucose (mmol/l) | in non-fasting state | 36 months | 
| Haemophilia activities of daily life (HAL) | Total score | 36 months | 
| Shortened Fat List | Total score | 36 months |