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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis; Osteoarthritis, Knee; Osteo Arthritis Knee; Osteoarthritis, Hip
• Intervention / Treatment: Behavioral: Alberta Healthy Living Program; Behavioral: Osteoarthritis advice; Behavioral: Physiotherapy; Behavioral: Alberta Obesity Centre Program

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Miriam Berchuk, MD; Phone Number: 403-943-8720; Email: miriam.berchuk@ucalgary.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • Recruiting
      • University of Calgary
      • Contact: Miriam Berchuk, MD; Phone Number: 403-943-8720; Email: miriam.berchuk@ucalgary.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Alberta Healthy Living Program; An integrated community-based chronic disease management program available to residents of Alberta.	Behavioral: Alberta Healthy Living Program; Weight management services; Behavioral: Osteoarthritis advice; Living Your Best Life with Osteoarthritis Handbook; Behavioral: Physiotherapy; GLA:D physiotherapy programs.; Other Names: GLA:D (TM) education and exercise
Experimental: Alberta Obesity Centre Program; Evidence-based medical management of obesity using a multidisciplinary approach.	Behavioral: Osteoarthritis advice; Living Your Best Life with Osteoarthritis Handbook; Behavioral: Physiotherapy; GLA:D physiotherapy programs.; Other Names: GLA:D (TM) education and exercise; Behavioral: Alberta Obesity Centre Program; Multi-disciplinary obesity management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body mass	Change in body mass (weight loss)	0-12 months
Decision to proceed with joint replacement surgery	Yes/no decision to proceed with joint replacement surgery	12 months
Change in waist circumference	waist circumference (centimetres)	0-12 months
Change in blood pressure	blood pressure (millimetres of mercury)	0-12 months
Change in blood lipid profile	blood lipids	0-12 months
Change in glycemic control	glycated hemoglobin (HbA1c)	0-12 months
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
Change in medication usage	All prescription medications will be tracked and recorded by a study physician	0-12 months

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2022
• Primary Completion (Anticipated): August 31, 2024
• Study Completion (Anticipated): August 31, 2024

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
• Other Study ID Numbers: REB19-1814

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No