Clinical trial NCT04439019: Group Education & Lifestyle Modification's Impact on Weight Loss & Quality Life of Patients with OA
Official title: Group Education and Digitally Delivered Lifestyle Modification Program to Enable Weight Loss and Improve Metabolic Health and Quality of Life for Patients with Osteoarthritis and Overweight/obesity.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Osteo Arthritis Knee
Osteoarthritis, Hip
Keywords: Obesity
carbohydrate restriction
Osteoarthritis
weight loss
Lead sponsor: Alberta Hip and Knee Clinic
Sponsor class: OTHER
Collaborators: name: University of Calgary
First posted: 2020-06-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The "OA Optimization Program" is a lifestyle and dietary modification program. All Patients will be offered this optional program while they await orthopedic consultation. There is an initial group information session for participants followed by 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 1 year, or until their surgical date Patients are encouraged to attend sessions with a family members. We intend to demonstrate 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Symptomatic osteoarthritis
* BMI ≥ 25

Exclusion Criteria:

* Age \< 18
* Currently following a specialized or therapeutic diet
* Pregnant or breastfeeding
* Type 1 Diabetes
* Unable to read or speak English
* Unwilling to use the digital application

Primary outcomes:
measure: BMI
timeFrame: every 3 months over 12 months.
Secondary outcomes:
measure: Blood pressure
timeFrame: every 3 months over 12 months.
measure: serum lipids and markers of inflammation/ Glycemic acid
timeFrame: every 3 months over 12 months.
measure: Health-related quality of life
timeFrame: every 3 months over 12 months.
measure: Pain and functional limitation
timeFrame: every 3 months over 12 months.
measure: Medication use
timeFrame: every 3 months over 12 months.
measure: waist circumference
timeFrame: every 3 months over 12 months.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Hip and Knee Clinic
state: Alberta
Study officials:
References: