NCT05608863

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Nov 2022Dec 2026

First Submitted

Initial submission to the registry

October 26, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

November 2, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

4.2 years

First QC Date

October 26, 2022

Last Update Submit

August 5, 2025

Conditions

Hemophilia

Outcome Measures

Primary Outcomes (1)

  • kg

    The main study parameter is body weight in kg.

    36 months

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Other Outcomes (3)

  • 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

Study Arms (2)

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

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

Other: Lifestyle - individual coaching

Interventions

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.

Combined intervention
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.

individual intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RadboudUMC

Nijmegen, Gelderland, 6500HB, Netherlands

Location

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Britta AP Laros - van Gorkom, MD, PhD, BSc

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2022

First Posted

November 8, 2022

Study Start

November 2, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)