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Trial registered on ANZCTR


Registration number
ACTRN12615000490572
Ethics application status
Approved
Date submitted
30/04/2015
Date registered
18/05/2015
Date last updated
8/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of a telephone-based weight management program for patients with knee osteoarthritis who are overweight or obese.
Scientific title
In patients with knee osteoarthritis, who are overweight or obese, does referral to a telephone-based weight management and coaching program, compared to usual care, decrease patient pain.
Secondary ID [1] 286614 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 294930 0
Overweight and obesity 294931 0
Condition category
Condition code
Musculoskeletal 295180 295180 0 0
Osteoarthritis
Diet and Nutrition 295181 295181 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive a telephone-based behaviour change intervention, focusing on weight reduction and the adoption of a healthy lifestyle program (referral to the 'Get Healthy Information and Coaching Service' (GHS)). The GHS offers 10 individually tailored coaching sessions delivered by university qualified health coaches over a 6-month period. Each coaching sessions is designed to provide ongoing support in maintaining participant motivation, overcoming barriers, setting goals and making positive and sustainable lifestyle and behaviour changes, regarding diet, physical activity, and achieving and maintaining a healthy weight.

Coaching sessions are provided on a tapered schedule, with a higher intensity of calls occurring in the first 12 weeks of the program. However, the frequency of the telephone sessions are tailored to the participants individual needs. Printed support materials will be mailed to participants after the first telephone call, and will include an information booklet and a coaching journal. During the first telephone call, participants will complete a short health assessment and be asked about their current lifestyle habits and other information regarding their individual circumstances. The remaining 9 telephone calls provide information aimed to support participants to improve their dietary intake and physical activity and assist them in achieving and maintaining a healthy weight.
Intervention code [1] 291747 0
Lifestyle
Intervention code [2] 291748 0
Behaviour
Comparator / control treatment
Active (usual care) controls will be used. Patients allocated to the control group will receive standard care and take part in data collection during the 6-month intervention. In addition, the control group will receive the same brief advice as the intervention group during baseline data collection telephone calls. The brief advice provides patients with an understanding of the importance in improving health related behaviours, including physical activity and dietary behaviours, and the relationship between these behaviours and weight management and improvements in knee pain.
Control group
Active

Outcomes
Primary outcome [1] 294941 0
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'.
Timepoint [1] 294941 0
Baseline and at 2, 6, 10, 14, 18, 22 and 26 weeks after randomisation.
Secondary outcome [1] 314411 0
Disability and function assessed using the Western Ontario and McMaster Universities Osteoarthritis Index.
Timepoint [1] 314411 0
Baseline and at 6 and 26 weeks after randomisation.
Secondary outcome [2] 314412 0
Patient quality of life assessed using the SF-12.v2.
Timepoint [2] 314412 0
Baseline and at 6 and 26 weeks after randomisation.
Secondary outcome [3] 314413 0
Diet assessed using a short food frequency questionnaire.
Timepoint [3] 314413 0
Baseline and at 6 and 26 weeks after randomisation.
Secondary outcome [4] 314414 0
Physical activity assessed using the Active Australia Survey.
Timepoint [4] 314414 0
Baseline and at 6 and 26 weeks after randomisation.
Secondary outcome [5] 317837 0
Weight (kg) assessed by a trained research assistant using a portable digital scale measured to the nearest 0.1kg.
Timepoint [5] 317837 0
26 weeks post-randomisation

Eligibility
Key inclusion criteria
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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants have been previously contacted by Population Health as part of a cohort study. They are patients with musculoskeletal conditions, waiting for consultation with an orthopaedic specialist at the Royal Newcastle Centre at the John Hunter Hospital, NSW Australia.

Trained interviewers will contact patients with knee osteoarthritis and a BMI between 27 and 40 via telephone for eligibility screening and baseline data collection. Eligible patients who consent to participate will be randomised to either intervention or control in a 1:1 ratio, using a computer generated randomisation schedule generated by an independent statistician.

Following screening and Baseline assessment, the interviewer will open an opaque envelope containing the group allocation. The participant will then be advised on the specific program details (i.e. continue as part of the cohort (control) or be referred to the health coaching service (intervention)).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule was generated using a priori by an independent statistician using SAS 9.3 through the SelectSurvey procedure.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data will be analysed using an intention-to-treat model and by a statistician blinded to group allocation.

Primary outcome analysis.
For pain intensity we will use linear mixed models with random intercepts for individuals to account for correlation of repeated measures (pain). The model will include terms for important prognostic factors measured using priori to randomisation and specified a priori. We will obtain estimates of the effect of the intervention and 95% confidence intervals by constructing linear contrasts to compare the adjusted mean change in outcome from baseline to each time point between the treatment and control groups. For weight we will compare the proportional reduction in weight between groups using t-tests. We will analyse the effect of treatment separately for each outcome.
We will also conduct a sensitivity analysis of weight loss using self-report measure in a linear mixed model.

Secondary outcomes analysis.
We will analyse the effect of treatment separately for each outcome using linear mixed models with random intercepts for individuals to account for correlation of repeated measures. As per primary model we will include terms for important prognostic factors measured prior to randomisation and specified a priori. We will obtain estimates of the effect of the intervention and 95% confidence intervals by constructing linear contrasts to compare the adjusted mean change (continuous variables) or difference in proportions (dichotomous variables) in outcome from baseline to each time point between the treatment and control groups.

Sample Size
Sample size calculations allow for two primary outcomes. Using a standard deviation of 2.7, a two-sided alpha of 0.025 (to account for multiple primary analyses) and allowing for 15% lost to follow up, a sample of 60 participants per group will, will give 90% power to detect a clinically meaningful difference of 2 in pain intensity between intervention and control groups. This sample also provides 80% power to detect a 5kg difference between at follow up – this accounts for 6% reduction in weight and hypothesized to be lead to a clinically meaningful reduce in pain.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/05/2015
Actual
19/05/2015
Date of last participant enrolment
Anticipated
19/06/2015
Actual
30/06/2015
Date of last data collection
Anticipated
28/01/2016
Actual
22/03/2016
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3737 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment postcode(s) [1] 9616 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 291184 0
Government body
Name [1] 291184 0
Hunter New England Population Health, Hunter New England Local Health District.
Country [1] 291184 0
Australia
Funding source category [2] 291185 0
University
Name [2] 291185 0
The University of Newcastle, Faculty of Health, School of Medicine and Public Health.
Country [2] 291185 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Population Health, Hunter New England Local Health District.
Address
Locked Bag 10, Wallsend, NSW 2287
Country
Australia
Secondary sponsor category [1] 289864 0
University
Name [1] 289864 0
The University of Newcastle, Faculty of Health, School of Medicine and Public Health.
Address [1] 289864 0
University Drive, Callaghan, NSW 2308
Country [1] 289864 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292756 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 292756 0
Ethics committee country [1] 292756 0
Australia
Date submitted for ethics approval [1] 292756 0
Approval date [1] 292756 0
20/04/2015
Ethics approval number [1] 292756 0
13/12/12/5.18

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56866 0
Dr Christopher M Williams
Address 56866 0
Hunter New England Population Health, Locked Bag 10, Wallsend, NSW 2287
Country 56866 0
Australia
Phone 56866 0
+ 61 2 49246102
Fax 56866 0
Email 56866 0
Christopher.M.Williams@hnehealth.nsw.gov.au
Contact person for public queries
Name 56867 0
Christopher M Williams
Address 56867 0
Hunter New England Population Health, Locked Bag 10, Wallsend, NSW 2287
Country 56867 0
Australia
Phone 56867 0
+ 61 2 49246102
Fax 56867 0
Email 56867 0
Christopher.M.Williams@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 56868 0
Christopher M Williams
Address 56868 0
Hunter New England Population Health, Locked Bag 10, Wallsend, NSW 2287
Country 56868 0
Australia
Phone 56868 0
+ 61 2 49246102
Fax 56868 0
Email 56868 0
Christopher.M.Williams@hnehealth.nsw.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTelephone-based weight loss support for patients with knee osteoarthritis: a pragmatic randomised controlled trial.2018https://dx.doi.org/10.1016/j.joca.2018.01.003
N.B. These documents automatically identified may not have been verified by the study sponsor.