Clinical trial NCT05389371: OA Optimization Program Pilot Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Osteo Arthritis Knee
Osteoarthritis, Knee
Osteoarthritis, Hip
Osteoarthritis
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: University of British Columbia
First posted: 2022-05-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel-arm randomized trial
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Determine the number of adults with osteoarthritis and obesity that are eligible to participate in the trial
timeFrame: 0-12 months
measure: The number of these adults with osteoarthritis and obesity who would be willing to take part in this trial
timeFrame: 0-12 months
measure: The characteristics of these adults with osteoarthritis and obesity who are willing to take part in the trial
timeFrame: 0-12 months
measure: The number and percentage of participants retained at 12-months
timeFrame: 0-12 months
Secondary outcomes:
measure: Change in body mass
timeFrame: 0-12 months
measure: Decision to proceed with joint replacement surgery
timeFrame: 12 months
measure: Change in waist circumference
timeFrame: 0-12 months
measure: Change in blood pressure
timeFrame: 0-12 months
measure: Change in blood lipid profile
timeFrame: 0-12 months
measure: Change in glycemic control
timeFrame: 0-12 months
measure: Change in quality of life
timeFrame: 0-12 months
measure: Change in medication usage
timeFrame: 0-12 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
References: