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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined intervention | Active Comparator | 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 |
|
| individual intervention | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle - group sessions | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| kg | The main study parameter is body weight in kg. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal circumference (cm) | 36 months | |
| Number of spontaneous bleeds | 36 months | |
| Number of induced bleeds |
| Measure | Description | Time Frame |
|---|---|---|
| BREQ-3 questionnaire | Baseline (week 0) | |
| Regulation of Eating Behaviour Scale (REBS) | Baseline (week 0) | |
| Patient satisfaction with the program will be measured using some questions |
Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Britta AP Laros - van Gorkom, MD, PhD, BSc | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RadboudUMC | Nijmegen | Gelderland | 6500HB | Netherlands |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Lifestyle - individual coaching | Other | 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. |
|
| 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 |
| 36 months |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |