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Osteo Arthritis KneePhase 1/2NCT05389371

OA Optimization Program Pilot Trial

A Phase 1/2 study testing Alberta Healthy Living Program, Alberta Obesity Centre Program and Osteoarthritis advice in people with Osteo Arthritis Knee and Osteoarthritis, Knee, run by University of Calgary at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Alberta Healthy Living Program, Alberta Obesity Centre Program and Osteoarthritis advice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteCanada
Study dates
28 Jun 2022to 30 Sep 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Calgary

    Calgary, Alberta, T2N 1N4

Other trials in Canada

About this study

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

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.

Being tested
Alberta Healthy Living Program, Alberta Obesity Centre Program, Osteoarthritis advice, Physiotherapy
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alberta Healthy Living ProgramBehavioural

    Weight management services

  • Alberta Obesity Centre ProgramBehavioural

    Multi-disciplinary obesity management

  • Osteoarthritis adviceBehavioural

    Living Your Best Life with Osteoarthritis Handbook

  • PhysiotherapyBehavioural

    Also called GLA:D (TM) education and exercise

    GLA:D physiotherapy programs.

Study groups in NCT05389371
Study groupRoleWhat they receive
Alberta Healthy Living ProgramActive comparatorAn integrated community-based chronic disease management program available to residents of Alberta.
Receives: Behavioral: Alberta Healthy Living Program; Behavioral: Osteoarthritis advice; Behavioral: Physiotherapy
Alberta Obesity Centre ProgramExperimentalEvidence-based medical management of obesity using a multidisciplinary approach.
Receives: Behavioral: Alberta Obesity Centre Program; Behavioral: Osteoarthritis advice; Behavioral: Physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the number of adults with osteoarthritis and obesity that are eligible to participate in the trial

    The number of patients approached

    Measured: 0-12 months

  2. 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

    Measured: 0-12 months

  3. 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

    Measured: 0-12 months

  4. 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

    Measured: 0-12 months

Secondary outcomes (8)

  1. Change in body mass

    Change in body mass (weight loss)

    Measured: 0-12 months

  2. Decision to proceed with joint replacement surgery

    Yes/no decision to proceed with joint replacement surgery

    Measured: 12 months

  3. Change in waist circumference

    waist circumference (centimetres)

    Measured: 0-12 months

  4. Change in blood pressure

    blood pressure (millimetres of mercury)

    Measured: 0-12 months

  5. Change in blood lipid profile

    blood lipids

    Measured: 0-12 months

  6. Change in glycemic control

    glycated hemoglobin (HbA1c)

    Measured: 0-12 months

  7. Change in quality of life

    Quality of life measured by the Alberta Bone and Joint Health Institute Hip and Knee Replacement Outcomes Tool

    Measured: 0-12 months

  8. Change in medication usage

    All prescription medications will be tracked and recorded by a study physician

    Measured: 0-12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2022
  2. Study start28 Jun 2022
  3. Primary completion31 Aug 2024 (estimated)
  4. Study completion30 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
parallel-arm randomized trial
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05389371
Sponsor's protocol ID
REB19-1814
Status last verified
Nov 2023
First submitted
19 May 2022
Last updated
22 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Alberta Healthy Living Program, Alberta Obesity Centre Program and Osteoarthritis advice in people with Osteo Arthritis Knee and Osteoarthritis, Knee, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the number of adults with osteoarthritis and obesity that are eligible to participate in the trial (time frame: 0-12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05389371.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.

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