Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04439019 |
| Other study ID # |
REB19-1814 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2021 |
| Est. completion date |
October 2023 |
Study information
| Verified date |
January 2021 |
| Source |
Alberta Hip and Knee Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Patients referred to Calgary's Alberta Hip & Knee Clinic, while awaiting consultation with an
orthopedic surgeon for hip or knee osteoarthritis, will be offered the opportunity to
participate in a dietary counseling program with the goal of attaining weight loss prior to
surgery. Those patients interested in participating in the program will be offered the
opportunity to participate in the research trial.
Description:
Obesity, osteoarthritis, and metabolic syndrome are interrelated diseases. In addition to
surgical management, there is the need to identify and provide earlier non-surgical
management for individuals with metabolic and body composition changes that are contributing
to osteoarthritis progression.
It has been well-established that is a challenge for clinicians to identify and deliver
optimal treatment approaches for patients with osteoarthritis and obesity. The long wait
times for orthopedic consultation in Alberta present an excellent opportunity to optimize
patients with medical comorbidities and can simultaneously improve the pain and disability
from their osteoarthritis. This is also an excellent opportunity to involve patients and
their families in co-managing their own disease and working towards better health and less
pain and disability.
The "OA Optimization Program" has been developed by Dr Berchuk, FRCPC, Diplomat of the
American Board of Obesity Medicine. It is a lifestyle and dietary modification program. In
cooperation with Calgary's Alberta Hip and Knee Clinic at Gulf Canada Square, Dr Berchuk will
offer patients this program while they await orthopedic consultation. This is an optional
program offered to all patients. There is an initial group information session for patients
who express interest. For those who choose to enroll, the program begins with a medical
assessment by Dr Berchuk. The initial consultation consists of a medical assessment which
includes medical history and physical examination, a previous dietary history, a readiness
for change assessment, and screening for contraindications to the program. The patients will
then attend group counselling sessions every 3 months for one year, or until their surgical
date. The group counselling will be supplemented by the Grohealth digital therapeutic
nutrition program. Participants return for group counselling sessions at Gulf Canada Square
clinic every 3 months until orthopedic consultation and if surgery is deemed appropriate,
until surgery.
As with any major lifestyle change, peer support is crucial to long term success. Patients
are encouraged to bring their family members to the initial consultation and to group
sessions. During the group sessions, Dr Berchuk will use techniques to encourage the building
of a peer support network, as well as medical cognitive behavior therapy techniques.
Investigators intend to demonstrate that the use of the OA Optimization program can lead to
improvement in Quality of Life measures including pain and disability in patients with severe
osteoarthritis, as well as improvements in markers of health such as BMI, waist
circumference, blood pressure, medication use in diabetic and hypertensive patients, and
markers such as serum lipids and markers of inflammation. It is entirely plausible that with
preoperative weight loss and/or improvement in metabolic disease, patients may see such
dramatic improvement in their symptoms that they choose to postpone surgery.
Research Question and Objectives:
Can the OA Optimization Program lead to improvement in pain and disability related to severe
osteoarthritis? Investigators aim to demonstrate that the use of a lifestyle and dietary
counselling program can lead to improvements in pain and disability in patients with severe
osteoarthritis.
Can the OA Optimization Program demonstrate significant improvements in obesity,
hypertension, hyperlipidemia, and glycemic control? Investigators aim to demonstrate
improvements in markers of health such as decreased BMI, decreased waist circumference,
decreased medication use in diabetic and hypertensive patients, improvement in biomarkers
such as serum lipids and serum markers of systemic inflammation.
