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ObesityNCT04439019

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

A study testing Lifestyle and dietary modification program in people with Obesity and Osteo Arthritis Knee, run by Alberta Hip and Knee Clinic at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Osteo Arthritis Knee, Osteoarthritis, Hip
What is being tested?
Lifestyle and dietary modification program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCanada
Study dates
1 Oct 2021to 30 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptomatic osteoarthritis
  • BMI ≥ 25

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Alberta Hip and Knee Clinic

    Calgary, Alberta

Other trials in Canada

About this study

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.

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.

Being tested
Lifestyle and dietary modification program
Keywords
Obesity, carbohydrate restriction, Osteoarthritis, weight loss
Medical subject headings
Obesity, Osteoarthritis, Hip, Osteoarthritis, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle and dietary modification programOther

    Also called Osteoarthritis(OA) Optimization 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.

Study groups in NCT04439019
Study groupRoleWhat they receive
All patients referred to the Alberta Hip and Knee ClinicExperimentalAll patients who are diagnosed with severe osteoarthritis undergoing total hip/knee replacement surgery and show interest to be part of the study.
Receives: Other: Lifestyle and dietary modification program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BMI

    Change in BMI compared to last visit

    Measured: every 3 months over 12 months.

Secondary outcomes (6)
  1. Blood pressure

    Change in blood pressure compared to last visit

    Measured: every 3 months over 12 months.

  2. serum lipids and markers of inflammation/ Glycemic acid

    Change in blood markers compared to last visit

    Measured: every 3 months over 12 months.

  3. Health-related quality of life

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

    Measured: every 3 months over 12 months.

  4. Pain and functional limitation

    Pain and functional limitation as measured by WOMAC

    Measured: every 3 months over 12 months.

  5. Medication use

    Changes in use of diabetic and blood pressure medication

    Measured: every 3 months over 12 months.

  6. waist circumference

    Comparing waist circumference to last visit

    Measured: every 3 months over 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2020
  2. Study start1 Oct 2021
  3. Primary completion30 Jan 2025
  4. Study completion30 Jan 2025

Why it stopped: Investigator decision to withdraw study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04439019
Sponsor's protocol ID
REB19-1814
Status last verified
Jan 2025
First submitted
27 Feb 2020
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle and dietary modification program in people with Obesity and Osteo Arthritis Knee, run by Alberta Hip and Knee Clinic at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BMI (time frame: every 3 months over 12 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.

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