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

Primary Purpose

Hemophilia

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Lifestyle - group sessions
Lifestyle - individual coaching
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemophilia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • RadboudUMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Combined intervention

individual intervention

Arm 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

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

Outcomes

Primary Outcome Measures

kg
The main study parameter is body weight in kg.

Secondary Outcome Measures

Abdominal circumference (cm)
Number of spontaneous bleeds
Number of induced bleeds
Units coagulation factor concentrate used/year (IU)
Blood-pressurre (mm Hg)
Cholesterol spectrum
including: total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol (mmol/l), all in non-fasting state
Glucose (mmol/l)
in non-fasting state
Haemophilia activities of daily life (HAL)
Total score
Shortened Fat List
Total score

Full Information

First Posted
October 26, 2022
Last Updated
December 21, 2022
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05608863
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined intervention
Arm Type
Active Comparator
Arm 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
Arm Title
individual intervention
Arm Type
Active Comparator
Arm 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
Intervention Type
Other
Intervention Name(s)
Lifestyle - group sessions
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Lifestyle - individual coaching
Intervention 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.
Primary Outcome Measure Information:
Title
kg
Description
The main study parameter is body weight in kg.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Abdominal circumference (cm)
Time Frame
36 months
Title
Number of spontaneous bleeds
Time Frame
36 months
Title
Number of induced bleeds
Time Frame
36 months
Title
Units coagulation factor concentrate used/year (IU)
Time Frame
36 months
Title
Blood-pressurre (mm Hg)
Time Frame
36 months
Title
Cholesterol spectrum
Description
including: total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol (mmol/l), all in non-fasting state
Time Frame
36 months
Title
Glucose (mmol/l)
Description
in non-fasting state
Time Frame
36 months
Title
Haemophilia activities of daily life (HAL)
Description
Total score
Time Frame
36 months
Title
Shortened Fat List
Description
Total score
Time Frame
36 months
Other Pre-specified Outcome Measures:
Title
BREQ-3 questionnaire
Time Frame
Baseline (week 0)
Title
Regulation of Eating Behaviour Scale (REBS)
Time Frame
Baseline (week 0)
Title
Patient satisfaction with the program will be measured using some questions
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
R Lubbers, PhD
Phone
0243614794
Email
studies.hemat@radboudumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
trial office
Phone
0243614797
Email
studies.hemat@radboudumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Britta AP Laros - van Gorkom, MD, PhD, BSc
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
RadboudUMC
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Britta AP Laros - van Gorkom, MD PhD BSc
First Name & Middle Initial & Last Name & Degree
trial office
Phone
0243614797
Email
studies.hemat@radboudumc.nl

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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