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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04733053
Registration number
NCT04733053
Ethics application status
Date submitted
13/01/2021
Date registered
1/02/2021
Date last updated
16/05/2023
Titles & IDs
Public title
Effects of a Physiotherapist-delivered Dietary Weight Loss Program in People With Knee OA Who Have Overweight/Obesity
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Scientific title
The POWER Study: Effects of a Physiotherapist-delivered Dietary Weight Loss Program in Addition to Exercise in People With Knee Osteoarthritis Who Have Overweight or Obesity - a Randomised Controlled Trial
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Secondary ID [1]
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U1111-1261-5151
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis
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Overweight and Obesity
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Diet and Nutrition
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Obesity
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Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Diet plus exercise
Other interventions - Exercise
Experimental: Diet plus exercise - The initial physiotherapy consultation for participants in this group will last 75 minutes, with 30 minutes for the exercise component and 45 minutes for the diet component. Thereafter, consultations will last 50 minutes, with 20 minutes for the exercise component and 30 minutes for the diet component. The exercise component will be the same as that described for the exercise alone group.
Active Comparator: Exercise - Physiotherapy consultations for participants in this group will last 30 minutes initially and then 20 minutes thereafter, consistent with clinical practice. Physiotherapists will prescribe 5-6 strengthening exercises from a pre-determined list to be performed at home three times/week, including two quadriceps exercises, one each for hip abductors, hamstrings and calf, and any other as appropriate and a personalised physical activity plan.
Other interventions: Diet plus exercise
The diet program has two phases: 1) intensive weight loss through a ketogenic very low calorie diet VLCD, and 2) transition from ketogenic VLCD onto a healthy eating plan for weight maintenance. Meal replacements will be provided to participants free of charge from the start of the trial to a maximum of 14 weeks (12 weeks for the ketogenic diet and 2 weeks for transition). If a participant does not wish to transition off the ketogenic diet after 14 weeks but wants to continue or if they wish to recommence the ketogenic diet any time after week 14 they will need to purchase meal replacements themselves at their own cost.
Participants will be encouraged to aim to lose at least 10% body weight.
Other interventions: Exercise
The trial coordinator will have provided participants with educational material about OA, handouts of home exercises including photographs and descriptions, a logbook for recording home program completion and resistance exercise bands ahead of their first appointment. Physiotherapists will prescribe 5-6 strengthening exercises from a pre-determined list to be performed at home three times/week, including two quadriceps exercises, one each for hip abductors, hamstrings and calf, and any other as appropriate. Review and modification will occur at each consultation to maintain moderate intensity (effort of =5 out of 10 (hard) on a modified Borg Rating of Perceived Exertion scale). The physiotherapist will also prescribe a personalised physical activity plan in collaboration with the participant that is supported and progressed over time.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Body weight
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Assessment method [1]
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Measured using calibrated digital laboratory platform scales (TCS-2 series) to 2 decimal places, the percentage of body weight change (baseline-follow up/baseline x100%) will be calculated as the primary outcome
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Timepoint [1]
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Change between baseline and 6 months post randomization
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Secondary outcome [1]
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Body mass index (BMI)
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Assessment method [1]
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Calculated from height and weight, in Kg/m2
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Timepoint [1]
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Change between baseline and 6 months post randomization
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Secondary outcome [2]
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Waist circumference
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Assessment method [2]
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Measured according to standardised instructions using a tape measure in centimetres to 1 decimal place
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Timepoint [2]
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Change between baseline and 6 months post randomization
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Secondary outcome [3]
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Waist to hip ratio
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Assessment method [3]
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Measured according to standardized instructions using a tape measure and presented as a ratio
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Timepoint [3]
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Change between baseline and 6 months post randomization
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Secondary outcome [4]
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Severity of knee pain during walking
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Assessment method [4]
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Scored on an 11-point NRS for average knee pain during walking in the last week, Ranges from 0 to 10; where 0=no pain and 10=worst pain possible
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Timepoint [4]
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Change between baseline and 6 months post randomization
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Secondary outcome [5]
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Intermittent and constant osteoarthritis pain measure (iCOAP)
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Assessment method [5]
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11-item tool with constant and intermittent pain subscales. Ranges from 0 to 20 for constant pain subscale and 0 to 24 for intermittent subscale and 0 to 44 for total score with 44 being maximal pain
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Timepoint [5]
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Change between baseline and 6 months post randomization
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Secondary outcome [6]
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Physical function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
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Assessment method [6]
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Scored using 17 questions regarding knee function in the last 48 hours, with Likert response options ranging from no dysfunction to extreme dysfunction. Ranges from 0 (no dysfunction) to 68 (maximum dysfunction)
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Timepoint [6]
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Change between baseline and 6 months post randomization
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Secondary outcome [7]
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Global overall improvement in knee problems
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Assessment method [7]
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Scored using a 7-point global rating of change Likert scale from with response options ranging from "much worse" to "much better" when compared to baseline. Participants who indicate that they are "moderately better" or "much better" will be classified as improved. All other respondents will be classified as not improved
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Timepoint [7]
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6 months post randomization
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Secondary outcome [8]
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Quality of life (AQoL-6D)
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Assessment method [8]
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Scored using the 20-item Assessment of Quality of Life II Instrument (6D version), which covers the topics of Independent Living, Relationships, Mental Health, Coping, Pain and Senses to come up with one overall value representing quality of life. Total score ranges from -0.04 to 1.00; higher scores indicate better quality of life
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Timepoint [8]
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Change between baseline and 6 months post randomization
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Secondary outcome [9]
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Physical Activity scale for the elderly (PASE)
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Assessment method [9]
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Scored via 10 questions about frequency and duration of recreational, household and occupational physical activity undertaken over the past 7 days. Scores range from 0 to 400+; higher scores indicate greater levels of physical activity
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Timepoint [9]
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Change between baseline and 6 months post randomization
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Secondary outcome [10]
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30 sec chair stand test
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Assessment method [10]
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Number of complete chair stands completed in 30 secs. Greater number indicates better function
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Timepoint [10]
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Change between baseline and 6 months post randomization
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Secondary outcome [11]
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40 m fast paced walk test
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Assessment method [11]
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Time to taken to walk 4 x 10 m quickly but safely. Measured in Metres/Second. Greater speed indicates better function
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Timepoint [11]
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Change between baseline and 6 months post randomization
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Secondary outcome [12]
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Stair climb test
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Assessment method [12]
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Time taken for participant to ascend and descend a flight of stairs. Measured in seconds, shorter time indicates better function
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Timepoint [12]
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Change between baseline and 6 months post randomization
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Secondary outcome [13]
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Quadriceps muscle strength
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Assessment method [13]
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Maximum voluntary isometric strength will be assessed using an isokinetic dynamometer with the knee at 60 degrees knee flexion. Peak torque over 3 maximal efforts lasting 3 seconds will be recorded. Measured in Nm/kg
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Timepoint [13]
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Change between baseline and 6 months post randomization
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Secondary outcome [14]
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Weight Self-Stigma Questionnaire (WSSQ)
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Assessment method [14]
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Self-reported and scored on a 12-item questionnaire, with two 6-item sub-scales. Each item rated on a 5-point Likert scale where from 1=completely disagree to 5=completely agree. Total and subscale scores will be reported with higher scores indicating greater internalized weight stigma.
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Timepoint [14]
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Change between baseline and 6 months post randomization
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Secondary outcome [15]
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Self-efficacy for eating control
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Assessment method [15]
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Weight Efficacy Lifestyle (WEL) Questionnaire Short Form. Scored from 8 statements regarding eating control on a 10-point NRS where 0="Not confident at all that I can resist the desire to eat" and 9="Very confident that I can resist the desire to eat". The WEL Short Form is validated to the original 20 item WEL which was based on 5 constructs [44]: negative emotions, availability, social pressure, physical discomfort, and positive activities. Total scores range from 0-80; higher scores indicate greater eating self-efficacy
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Timepoint [15]
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Change between baseline and 6 months post randomization
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Secondary outcome [16]
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Arthritis self-efficacy scale
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Assessment method [16]
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Arthritis self-efficacy scale short form. Scored from 8 questions on a 10-point NRS where 1="Very uncertain" and 10="Very certain". The scale assess self-efficacy for control of pain, physical function and frustration associated with OA. Scores are the mean of the items in each scale. Total scores are an average of the 8 items with a range from 1 to 10; higher scores indicate higher self-efficacy.
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Timepoint [16]
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Change between baseline and 6 months post randomization
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Eligibility
Key inclusion criteria
- Meet the National Institute for Health and Care Excellence [47] clinical criteria for
OA: age=45 years; activity-related knee joint pain; morning knee stiffness = 30 mins
- report history of knee pain = 3 months
- report knee pain on most days of the past month
- report a minimum knee pain score of 4 on an 11-point numeric rating scale during
walking over the previous week
- body mass index (BMI) >27 kg/m2
- those using hypertensive medication must be willing to have their blood pressure
checked (this can be self-monitoring, at a pharmacist or at a GP) if they feel
light-headed or dizzy at any point during the study
- able to give informed consent and to participate fully in the interventions and
assessment procedures
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Minimum age
45
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- weight >150 kgs (due to the added complexities of additional nutritional requirements
for individuals above this weight)
- inability to speak English
- on waiting list for/planning knee/hip surgery or bariatric surgery in next 6 months
- arthroplasty on affected knee
- recent knee surgery on affected knee (past 6 months);
- self-reported inflammatory arthritis (e.g. rheumatoid arthritis)
- weight loss of > 2 kg over the previous 3 months
- already actively trying to lose weight by any of the following mechanisms:using meal
replacements for weight loss; being a member of a slimming club (e.g. weight
watchers); receiving support from another health care professional for weight loss;
using any drugs prescribed to aid in weight loss; using structured meal programs for
weight loss such as 'Lite n' Easy'
- unwilling to continue current dietary patterns if randomized to exercise only group
- unable to undertake ketogenic VLCD for medical reasons including self-reported:
diagnosis of Type 1 diabetes;Type 2 diabetes requiring insulin or other medication
apart from metformin; Warfarin use; stroke or cardiac event in previous 6 months;
unstable cardiovascular conditions; fluid intake restrictions; renal (kidney) problems
(unless clearance is obtained from a general practitioner (GP), including GP
confirmation that estimated glomerular filtration rate >30 mL/min/1.73m2); any
neurological condition affecting lower limbs; vegan dietary requirements due to
complexity of delivering a nutritionally complete diet within the ketogenic diet
regime
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/10/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2023
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Sample size
Target
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Accrual to date
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Final
88
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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University of Melbourne - Melbourne
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Recruitment postcode(s) [1]
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3010 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Melbourne
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The aim of this randomized controlled trial is to evaluate the effects of a
physiotherapist-delivered dietary weight loss program on clinical outcomes among people with
knee osteoarthritis (OA) who have overweight or obesity. The primary hypothesis is that a
physiotherapist-delivered dietary weight loss plus exercise program will be more effective in
achieving weight loss than a physiotherapist-delivered exercise program alone. Approximately
6-9 physiotherapists in Melbourne, Australia will be recruited and trained in weight
management for OA patients, as well as trained in how to deliver the specific study
interventions. The same therapists will deliver the intervention in both arms of the trial.
88 participants with knee OA will be recruited from the community and randomized into one of
the two arms a) diet plus exercise intervention or b) exercise intervention alone.
Participants in both groups will be asked to attend 6 consultations with the physiotherapist
over 6 months. Questionnaire and laboratory-based outcome measures will be completed by
participants at baseline and at the end of the 6 month intervention period. A biostatistician
will analyse blinded, de-identified data.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04733053
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Kim Bennell, PhD
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Address
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University of Melbourne
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04733053
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