Skip to content

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

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05389371
Enrollment
70
Registered
2022-05-25
Start date
2022-06-28
Completion date
2025-09-30
Last updated
2024-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Osteoarthritis, Hip, Osteoarthritis, Knee, Osteo Arthritis Knee

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.

Interventions

BEHAVIORALAlberta Healthy Living Program

Weight management services

BEHAVIORALAlberta Obesity Centre Program

Multi-disciplinary obesity management

BEHAVIORALOsteoarthritis advice

Living Your Best Life with Osteoarthritis Handbook

BEHAVIORALPhysiotherapy

GLA:D physiotherapy programs.

Sponsors

University of British Columbia
CollaboratorOTHER
University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

parallel-arm randomized trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Determine the number of adults with osteoarthritis and obesity that are eligible to participate in the trial0-12 monthsThe number of patients approached
The number of these adults with osteoarthritis and obesity who would be willing to take part in this trial0-12 monthsThe number of patients who actually enroll
The characteristics of these adults with osteoarthritis and obesity who are willing to take part in the trial0-12 monthsPatient sex, gender, age, and medical history
The number and percentage of participants retained at 12-months0-12 monthsNumber and percentage of patients attending at 12-month follow up and reasons for drop-out

Secondary

MeasureTime frameDescription
Change in blood lipid profile0-12 monthsblood lipids
Change in glycemic control0-12 monthsglycated hemoglobin (HbA1c)
Change in body mass0-12 monthsChange in body mass (weight loss)
Change in medication usage0-12 monthsAll prescription medications will be tracked and recorded by a study physician
Change in quality of life0-12 monthsQuality of life measured by the Alberta Bone and Joint Health Institute Hip and Knee Replacement Outcomes Tool
Decision to proceed with joint replacement surgery12 monthsYes/no decision to proceed with joint replacement surgery
Change in waist circumference0-12 monthswaist circumference (centimetres)
Change in blood pressure0-12 monthsblood pressure (millimetres of mercury)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026