OA Optimization Program Pilot Trial
Use of a Virtual Weight Management Program to Enable Weight Loss and Improve Metabolic Health and Quality of Life for Patients With Osteoarthritis and Obesity
1 other identifier
interventional
70
1 country
1
Brief Summary
Total joint replacement is a highly successful treatment option for people affected by severe osteoarthritis (OA), however, the mismatch between resources and demand for this surgery means that many patients face long wait times while enduring worsening pain and disability. The Alberta Hip and Knee Program is a centralized intake system for patients referred for total joint replacement assessment. Over 3000 patients are assessed annually at the Calgary location (Alberta Hip and Knee Clinic at Gulf Canada Square) where previously patients waited an average of 43 weeks for a surgical consult then an additional 30 weeks until surgery. Given that many elective surgeries in Alberta have been cancelled in response to the COVID19 pandemic, these wait times have increased significantly, with no clearing of the surgical backlog for the foreseeable future. Long wait times for patients can become a spiral of more debility, less mobility, and subsequent weight gain. The current standard of care for patients with obesity awaiting surgery provides little support or guidance beyond general advice about the importance of a healthy weight and remaining active. This waiting period represents an untapped window of opportunity to intervene and help patients with obesity and OA to lessen their disease burden and improve overall health, while addressing patient priorities such as regaining lost function and improving quality of life. Many patients with osteoarthritis also have obesity. The best practices in obesity treatment requires a multidisciplinary approach. Our aim is to conduct a pilot randomized controlled trial (RCT) to evaluate the feasibility of incorporating the multidisciplinary Alberta Obesity Centre program into the clinical care pathway for patients with obesity and OA while they await surgical evaluation at the Alberta Hip and Knee Clinic at Gulf Canada Square. The results of this feasibility trial will help inform a larger scale trial that will be powered for clinical and health economics outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2022
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2022
CompletedFirst Posted
Study publicly available on registry
May 25, 2022
CompletedStudy Start
First participant enrolled
June 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedMay 22, 2024
November 1, 2023
2.2 years
May 19, 2022
May 20, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Determine the number of adults with osteoarthritis and obesity that are eligible to participate in the trial
The number of patients approached
0-12 months
The number of these adults with osteoarthritis and obesity who would be willing to take part in this trial
The number of patients who actually enroll
0-12 months
The characteristics of these adults with osteoarthritis and obesity who are willing to take part in the trial
Patient sex, gender, age, and medical history
0-12 months
The number and percentage of participants retained at 12-months
Number and percentage of patients attending at 12-month follow up and reasons for drop-out
0-12 months
Secondary Outcomes (8)
Change in body mass
0-12 months
Decision to proceed with joint replacement surgery
12 months
Change in waist circumference
0-12 months
Change in blood pressure
0-12 months
Change in blood lipid profile
0-12 months
- +3 more secondary outcomes
Study Arms (2)
Alberta Healthy Living Program
ACTIVE COMPARATORAn integrated community-based chronic disease management program available to residents of Alberta.
Alberta Obesity Centre Program
EXPERIMENTALEvidence-based medical management of obesity using a multidisciplinary approach.
Interventions
Multi-disciplinary obesity management
Living Your Best Life with Osteoarthritis Handbook
GLA:D physiotherapy programs.
Eligibility Criteria
You may qualify if:
- body mass index (weight in kilograms divided by height in metres squared) greater than 30
- symptomatic osteoarthritis (referred to the Alberta Hip and Knee Clinic for assessment for total joint replacement surgery)
You may not qualify if:
- Currently following a specialized or therapeutic diet
- pregnant or breastfeeding
- diagnosed with type 1 diabetes
- unable to read or speak English
- unable to use email
- unable to use virtual platforms such as Zoom
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- University of British Columbiacollaborator
Study Sites (1)
University of Calgary
Calgary, Alberta, T2N 1N4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2022
First Posted
May 25, 2022
Study Start
June 28, 2022
Primary Completion
August 31, 2024
Study Completion
September 30, 2025
Last Updated
May 22, 2024
Record last verified: 2023-11