跳至主要内容
临床试验/NCT04439019
NCT04439019撤回不适用

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.

Alberta Hip and Knee Clinic1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
100
试验地点
1
主要终点
BMI

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Symptomatic osteoarthritis

排除标准

  • 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

结局指标

主要结局

BMI

时间窗: every 3 months over 12 months.

Change in BMI compared to last visit

次要结局

  • serum lipids and markers of inflammation/ Glycemic acid(every 3 months over 12 months.)
  • waist circumference(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.)
  • Blood pressure(every 3 months over 12 months.)
  • Medication use(every 3 months over 12 months.)

研究者

发起方
Alberta Hip and Knee Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kelly Johnston

Assistant Clinical Professor

Alberta Hip and Knee Clinic

研究点 (1)

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