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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hemophilia
• Intervention / Treatment: Other: Lifestyle - group sessions; Other: Lifestyle - individual coaching

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500HB
      • Radboudumc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Combined intervention; 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	Other: Lifestyle - group sessions; 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.
Active Comparator: individual intervention; 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	Other: Lifestyle - individual coaching; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
kg	The main study parameter is body weight in kg.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal circumference (cm)		36 months
Number of spontaneous bleeds		36 months
Number of induced bleeds		36 months
Units coagulation factor concentrate used/year (IU)		36 months
Blood-pressurre (mm Hg)		36 months
Cholesterol spectrum	including: total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol (mmol/l), all in non-fasting state	36 months
Glucose (mmol/l)	in non-fasting state	36 months
Haemophilia activities of daily life (HAL)	Total score	36 months
Shortened Fat List	Total score	36 months

Other Outcome Measures

Outcome Measure	Time Frame
BREQ-3 questionnaire	Baseline (week 0)
Regulation of Eating Behaviour Scale (REBS)	Baseline (week 0)
Patient satisfaction with the program will be measured using some questions	36 months

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: Britta AP Laros - van Gorkom, MD, PhD, BSc, Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemophilia A
• Other Study ID Numbers: HEMSTOL75

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No