Group Education & Lifestyle Modification's Impact on Weight Loss & Quality Life of Patients With OA
Primary Purpose
Obesity, Osteo Arthritis Knee, Osteoarthritis, Hip
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lifestyle and dietary modification program
Sponsored by

About this trial
This is an interventional supportive care trial for Obesity focused on measuring Obesity, carbohydrate restriction, Osteoarthritis, weight loss
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All patients referred to the Alberta Hip and Knee Clinic
Arm Description
All patients who are diagnosed with severe osteoarthritis undergoing total hip/knee replacement surgery and show interest to be part of the study.
Outcomes
Primary Outcome Measures
BMI
Change in BMI compared to last visit
Secondary Outcome Measures
Blood pressure
Change in blood pressure compared to last visit
serum lipids and markers of inflammation/ Glycemic acid
Change in blood markers compared to last visit
Health-related quality of life
Health-related quality of life as measured by EQ-5D-5L
Pain and functional limitation
Pain and functional limitation as measured by WOMAC
Medication use
Changes in use of diabetic and blood pressure medication
waist circumference
Comparing waist circumference to last visit
Full Information
NCT ID
NCT04439019
First Posted
February 27, 2020
Last Updated
January 13, 2021
Sponsor
Alberta Hip and Knee Clinic
Collaborators
University of Calgary
1. Study Identification
Unique Protocol Identification Number
NCT04439019
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alberta Hip and Knee Clinic
Collaborators
University of Calgary
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Osteo Arthritis Knee, Osteoarthritis, Hip
Keywords
Obesity, carbohydrate restriction, Osteoarthritis, weight loss
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All patients referred to the Alberta Hip and Knee Clinic
Arm Type
Experimental
Arm Description
All patients who are diagnosed with severe osteoarthritis undergoing total hip/knee replacement surgery and show interest to be part of the study.
Intervention Type
Other
Intervention Name(s)
Lifestyle and dietary modification program
Other Intervention Name(s)
Osteoarthritis(OA) Optimization program
Intervention 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 member. 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 will be shown.
Primary Outcome Measure Information:
Title
BMI
Description
Change in BMI compared to last visit
Time Frame
every 3 months over 12 months.
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Change in blood pressure compared to last visit
Time Frame
every 3 months over 12 months.
Title
serum lipids and markers of inflammation/ Glycemic acid
Description
Change in blood markers compared to last visit
Time Frame
every 3 months over 12 months.
Title
Health-related quality of life
Description
Health-related quality of life as measured by EQ-5D-5L
Time Frame
every 3 months over 12 months.
Title
Pain and functional limitation
Description
Pain and functional limitation as measured by WOMAC
Time Frame
every 3 months over 12 months.
Title
Medication use
Description
Changes in use of diabetic and blood pressure medication
Time Frame
every 3 months over 12 months.
Title
waist circumference
Description
Comparing waist circumference to last visit
Time Frame
every 3 months over 12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
Group Education & Lifestyle Modification's Impact on Weight Loss & Quality Life of Patients With OA
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