BLOOM Forward: Investigating Weight Loss Impact on TJAC Patients
NCT06103552 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58
Last updated 2023-11-22
Summary
The goal of this clinical trial is to prospectively assess the efficacy of the BLOOM program, a comprehensive weight loss dietary and lifestyle program, in a population of patients living with obesity and awaiting hip or knee surgery. The main questions it seeks to answer are:
1. Can the BLOOM program support these patients to lose up to 10% of their initial body weight?
2. Will patients continue to lose weight for the next six months after completing the program?
3. Does the BLOOM program help patients to improve their overall quality of life?
Study participants will undergo the BLOOM program, a virtual pre-operative weight management program that spans 24 weeks and is carefully supervised by medical professionals. They will be recruited at the LEAF Clinic after being referred by their primary care physician.
During the BLOOM program, they will meet with a physician (initially, then once monthly) and a dietitian (initially, and then biweekly as part of virtual group coaching). They will have access to LEAF's online learning portal. These are normal elements of the BLOOM program.
Furthermore, as part of their participation in the research study, participants will be asked to complete the following questionnaires: the Mediterranean dietary score, the Oxford Hip and Knee Questionnaire and the EQ-D5-5L quality of life assessment. They will complete these initially, and then at completion of the program and 3 and 6 months post-program. We will also collect their height and weight at these intervals.
Conditions
- Obesity
- Knee Osteoarthritis
- Hip Osteoarthritis
- Arthroplasty Complications
Interventions
- BEHAVIORAL
-
Building Lifestyle Options for Orthopedic Mobility (BLOOM)
This intervention is a lifestyle program with includes dietary coaching from a dietitian and regular doctor appointments with a bariatric medicine specialist over the course of 24 weeks.
Sponsors & Collaborators
-
LEAF Weight Loss Clinic
collaborator UNKNOWN -
The Ottawa Hospital
collaborator OTHER -
Ottawa Hospital Research Institute
lead OTHER
Principal Investigators
-
Judy Shiau, MD · The Ottawa Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-12-31
- Primary Completion
- 2024-12-31
- Completion
- 2025-12-31
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