HemophiliaNCT05608863
He-move-philia, Lifestyle Intervention for Patients With Hemophilia
A study testing Lifestyle - group sessions and Lifestyle - individual coaching in people with Hemophilia, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemophilia
- What is being tested?
- Lifestyle - group sessions and Lifestyle - individual coaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Nov 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: He-move-philia, a Combined Lifestyle Intervention Program for Patients With Hemophilia and Other Bleeding Disorders
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.
Read the 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.
- Conditions
- Hemophilia
- Being tested
- Lifestyle - group sessions, Lifestyle - individual coaching
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle - group sessionsOther
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 coachingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Lifestyle - group sessions |
| 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 Receives: Other: Lifestyle - individual coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
kg
The main study parameter is body weight in kg.
Measured: 36 months
Secondary outcomes (9)
Abdominal circumference (cm)
Measured: 36 months
Number of spontaneous bleeds
Measured: 36 months
Number of induced bleeds
Measured: 36 months
Units coagulation factor concentrate used/year (IU)
Measured: 36 months
Blood-pressurre (mm Hg)
Measured: 36 months
Cholesterol spectrum
including: total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol (mmol/l), all in non-fasting state
Measured: 36 months
Glucose (mmol/l)
in non-fasting state
Measured: 36 months
Haemophilia activities of daily life (HAL)
Total score
Measured: 36 months
Shortened Fat List
Total score
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start2 Nov 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Britta AP Laros - van Gorkom, MD, PhD, BSc, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608863
- Sponsor's protocol ID
- HEMSTOL75
- Status last verified
- Aug 2025
- First submitted
- 26 Oct 2022
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- He-move-philia, a Combined Lifestyle Intervention Program for Patients With Hemophilia and Other Bleeding Disorders
- ClinicalTrials.gov ID
- NCT05608863
- Acronym / sponsor ID
- HEMSTOL75
- Conditions
- Hemophilia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined intervention | Active comparator | Other: Lifestyle - group sessionsThe 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 | Other: Lifestyle - individual coachingThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle - group sessionsThe 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 | Combined intervention |
| Lifestyle - individual coachingThe 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 | individual intervention |
Primary outcome
kg
Time frame: 36 months
The main study parameter is body weight in kg.
9 secondary outcomes
Abdominal circumference (cm)
Time frame: 36 months
Number of spontaneous bleeds
Time frame: 36 months
Number of induced bleeds
Time frame: 36 months
Units coagulation factor concentrate used/year (IU)
Time frame: 36 months
Blood-pressurre (mm Hg)
Time frame: 36 months
Cholesterol spectrum
Time frame: 36 months
Glucose (mmol/l)
Time frame: 36 months
Haemophilia activities of daily life (HAL)
Time frame: 36 months
Shortened Fat List
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
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A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Britta AP Laros - van Gorkom, MD, PhD, BSc principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle - group sessions and Lifestyle - individual coaching in people with Hemophilia, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
kg (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.