A randomised controlled trial of a telephone-based weight management program for patients with knee osteoarthritis who are overweight or obese.
- Conditions
- Knee OsteoarthritisOverweight and obesityMusculoskeletal - OsteoarthritisDiet and Nutrition - Obesity
- Registration Number
- ACTRN12615000490572
- Lead Sponsor
- Hunter New England Population Health, Hunter New England Local Health District.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
Primary complaint of pain in the knee due to knee osteoarthritis.
Aged 18 years or over.
Classified as overweight or obese with a self-reported body mass index (BMI) between 27 or greater and less than 40.
Have access to and can use a telephone.
Duration of longer than 3 months since the onset of knee pain.
Average back pain intensity of 3 or greater out of 10 over the past week on a numerical rating scale of 0 to 10.
Moderate level of interference in activities of daily living (adaption of item 8 on SF-36).
A known or suspected serious pathology as the underlying cause of knee pain, such as a fracture, infection, rheumatoid arthritis or malignancy (cancer).
A previous history of obesity surgery.
Currently participating in any prescribed, medically supervised or commercial weight loss program.
Knee surgery in the last 6 months or planned surgery in the next 6 months.
Inability to walk unaided.
Unable to comply with the study protocol, adapt meals or exercise, due to non-independent living arrangements.
Any medical or physical impairment, apart from knee pain, precluding safe participation in exercise such as uncontrolled hypertension, or morbid obesity (BMI >40).
Cannot speak and read English.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain intensity measured as the average knee pain over the past week using a numerical rating scale of 0 to 10, where 0 is 'no pain' and 10 is 'the worst possible pain'.[Baseline and at 2, 6, 10, 14, 18, 22 and 26 weeks after randomisation.]
- Secondary Outcome Measures
Name Time Method Disability and function assessed using the Western Ontario and McMaster Universities Osteoarthritis Index.[Baseline and at 6 and 26 weeks after randomisation.];Patient quality of life assessed using the SF-12.v2.[Baseline and at 6 and 26 weeks after randomisation.];Diet assessed using a short food frequency questionnaire.[Baseline and at 6 and 26 weeks after randomisation.];Physical activity assessed using the Active Australia Survey.[Baseline and at 6 and 26 weeks after randomisation.];Weight (kg) assessed by a trained research assistant using a portable digital scale measured to the nearest 0.1kg.[26 weeks post-randomisation]