Group Education & Lifestyle Modification's Impact on Weight Loss & Quality Life of Patients with OA

NCT04439019 | Withdrawn

• 1 other identifier: REB19-1814
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Osteo Arthritis Knee; Osteoarthritis, Hip

Keywords

Obesity; carbohydrate restriction; Osteoarthritis; weight loss

Outcome Measures

Primary Outcomes (1)

• BMI

  Change in BMI compared to last visit

  every 3 months over 12 months.

Secondary Outcomes (6)

• Blood pressure

  every 3 months over 12 months.

• serum lipids and markers of inflammation/ Glycemic acid

  every 3 months over 12 months.

• Health-related quality of life

  every 3 months over 12 months.

• Pain and functional limitation

  every 3 months over 12 months.

• Medication use

  every 3 months over 12 months.

Study Arms (1)

All patients referred to the Alberta Hip and Knee Clinic

EXPERIMENTAL

All patients who are diagnosed with severe osteoarthritis undergoing total hip/knee replacement surgery and show interest to be part of the study.

Other: Lifestyle and dietary modification program

Interventions

Lifestyle and dietary modification program OTHER

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.

Also known as: Osteoarthritis(OA) Optimization program

All patients referred to the Alberta Hip and Knee Clinic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic osteoarthritis
• BMI ≥ 25

You may not qualify if:

• 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

Sponsors & Collaborators

• Alberta Hip and Knee Clinic: lead
• University of Calgary: collaborator

Study Sites (1)

Alberta Hip and Knee Clinic

Calgary, Alberta, Canada

Location

MeSH Terms

Conditions

Obesity; Osteoarthritis, Hip; Osteoarthritis; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Body Weight Changes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: June 19, 2020
• Study Start: October 1, 2021
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)