OA Optimization Program Pilot Trial

Osteoarthritis Clinical 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05389371
• Other study ID #: REB19-1814
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: June 28, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: November 2023
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: September 30, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Alberta Healthy Living Program
Weight management services
• Alberta Obesity Centre Program
Multi-disciplinary obesity management
• Osteoarthritis advice
Living Your Best Life with Osteoarthritis Handbook
• Physiotherapy
GLA:D physiotherapy programs.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Change in body mass	Change in body mass (weight loss)	0-12 months
Secondary	Decision to proceed with joint replacement surgery	Yes/no decision to proceed with joint replacement surgery	12 months
Secondary	Change in waist circumference	waist circumference (centimetres)	0-12 months
Secondary	Change in blood pressure	blood pressure (millimetres of mercury)	0-12 months
Secondary	Change in blood lipid profile	blood lipids	0-12 months
Secondary	Change in glycemic control	glycated hemoglobin (HbA1c)	0-12 months
Secondary	Change in quality of life	Quality of life measured by the Alberta Bone and Joint Health Institute Hip and Knee Replacement Outcomes Tool	0-12 months
Secondary	Change in medication usage	All prescription medications will be tracked and recorded by a study physician	0-12 months