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

Radboud University Medical Center

Status: Active, not recruiting

Conditions: Hemophilia

Treatments: Other: Lifestyle - individual coaching; Other: Lifestyle - group sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT05608863

HEMSTOL75

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Combined intervention

Active Comparator group

Description:

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

Treatment:

Other: Lifestyle - group sessions

individual intervention

Active Comparator group

Description:

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

Treatment:

Other: Lifestyle - individual coaching