Clinical trial NCT05608863: He-move-philia, Lifestyle Intervention for Patients With Hemophilia
Official title: He-move-philia, a Combined Lifestyle Intervention Program for Patients With Hemophilia and Other Bleeding Disorders
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hemophilia
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: kg
timeFrame: 36 months
Secondary outcomes:
measure: Abdominal circumference (cm)
timeFrame: 36 months
measure: Number of spontaneous bleeds
timeFrame: 36 months
measure: Number of induced bleeds
timeFrame: 36 months
measure: Units coagulation factor concentrate used/year (IU)
timeFrame: 36 months
measure: Blood-pressurre (mm Hg)
timeFrame: 36 months
measure: Cholesterol spectrum
timeFrame: 36 months
measure: Glucose (mmol/l)
timeFrame: 36 months
measure: Haemophilia activities of daily life (HAL)
timeFrame: 36 months
measure: Shortened Fat List
timeFrame: 36 months
Other outcomes:
measure: BREQ-3 questionnaire
timeFrame: Baseline (week 0)
measure: Regulation of Eating Behaviour Scale (REBS)
timeFrame: Baseline (week 0)
measure: Patient satisfaction with the program will be measured using some questions
timeFrame: 36 months
Locations:
city: Nijmegen
country: Netherlands
facility: RadboudUMC
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Britta AP Laros - van Gorkom, MD, PhD, BSc
role: PRINCIPAL_INVESTIGATOR
References: