CClinicalTrials.gg
WithdrawnNCT04439019Updated Feb 3, 2025

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

An interventional study of Lifestyle and dietary modification program in Obesity, Osteo Arthritis Knee and Osteoarthritis, Hip, sponsored by Alberta Hip and Knee Clinic. Withdrawn at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-03.

Sponsored by Alberta Hip and Knee Clinic · Not applicable, Interventional, and Supportive care

Why this study was withdrawn
Investigator decision to withdraw study.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity
  • Osteo Arthritis Knee
  • Osteoarthritis, Hip

Keywords

  • Obesity
  • carbohydrate restriction
  • Osteoarthritis
  • weight loss
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

Browse Osteoarthritis studies →

Lead sponsor

Alberta Hip and Knee Clinic is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Symptomatic osteoarthritis
  • BMI ≥ 25

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    All patients referred to the Alberta Hip and Knee Clinic

    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

  • OtherLifestyle and dietary modification program

    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

06

What researchers measure

Primary outcomes

  1. BMI

    Change in BMI compared to last visit

    Time frame: every 3 months over 12 months.

Secondary outcomes

  1. Blood pressure

    Change in blood pressure compared to last visit

    Time frame: every 3 months over 12 months.

  2. serum lipids and markers of inflammation/ Glycemic acid

    Change in blood markers compared to last visit

    Time frame: every 3 months over 12 months.

  3. Health-related quality of life

    Health-related quality of life as measured by EQ-5D-5L

    Time frame: every 3 months over 12 months.

  4. Pain and functional limitation

    Pain and functional limitation as measured by WOMAC

    Time frame: every 3 months over 12 months.

  5. Medication use

    Changes in use of diabetic and blood pressure medication

    Time frame: every 3 months over 12 months.

  6. waist circumference

    Comparing waist circumference to last visit

    Time frame: every 3 months over 12 months.

07

Study locations

1 site
  • Alberta Hip and Knee Clinic
    Calgary, Alberta, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04439019
Lead sponsor
Alberta Hip and Knee Clinic
Collaborators
University of Calgary
Responsible party
Kelly Johnston (Assistant Clinical Professor, Alberta Hip and Knee Clinic) — Principal investigator
First posted
Jun 19, 2020
Start date
Oct 1, 2021
Primary completion
Jan 30, 2025
Completion
Jan 30, 2025
Last update
Feb 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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