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NCT Number: NCT05608863

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RadboudUMC

Nijmegen, Gelderland, 6500HB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. kg

    Time frame: 36 months

    The main study parameter is body weight in kg.

Secondary outcomes

  1. Abdominal circumference (cm)

    Time frame: 36 months

  2. Number of spontaneous bleeds

    Time frame: 36 months

  3. Number of induced bleeds

    Time frame: 36 months

  4. Units coagulation factor concentrate used/year (IU)

    Time frame: 36 months

  5. Blood-pressurre (mm Hg)

    Time frame: 36 months

  6. Cholesterol spectrum

    Time frame: 36 months

    including: total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol (mmol/l), all in non-fasting state

  7. Glucose (mmol/l)

    Time frame: 36 months

    in non-fasting state

  8. Haemophilia activities of daily life (HAL)

    Time frame: 36 months

    Total score

  9. Shortened Fat List

    Time frame: 36 months

    Total score

Other outcomes

  1. BREQ-3 questionnaire

    Time frame: Baseline (week 0)

  2. Regulation of Eating Behaviour Scale (REBS)

    Time frame: Baseline (week 0)

  3. Patient satisfaction with the program will be measured using some questions

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2022
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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