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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04574804
Registration number
NCT04574804
Ethics application status
Date submitted
22/09/2020
Date registered
5/10/2020
Titles & IDs
Public title
Effects of an Online Training Program for Physiotherapists About Weight Management for People With Osteoarthritis
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Scientific title
Effects of an Online Training Program for Physiotherapists About Weight Management for People With Osteoarthritis
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Secondary ID [1]
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UMelbourne
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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:
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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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Online training program in weight management for osteoarthritis
Experimental: online training program - online training program Participants receive access to online training program consisting of 6 e-learning modules on topics of weight management in osteoarthritis, which they will be instructed to and encourage to complete over the 6 intervention period.
No intervention: control group - control group Participants do NOT receive access to the online training program consisting of 6 e-learning modules on topics of weight management in osteoarthritis during the intervention period.
Other interventions: Online training program in weight management for osteoarthritis
An evidence based online education training program for physiotherapists in weight management for osteoarthritis. Training modules cover the following topic areas:
1. Overweight and obesity and osteoarthritis
2. Overview of weight regulation, overweight and obesity
3. Examining weight stigma in physiotherapy and personal beliefs about weight
4. Communication approach for addressing weight management
5. Interventions for weight management
6. Health behaviour change support
These 6 e-learning modules comprise the online training program, access to which comprises the study intervention.
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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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Self-reported confidence in knowledge about weight management for patients with osteoarthritis
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Assessment method [1]
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Measured using an expert-developed, customized self-reported questionnaire exploring physiotherapists' perceived confidence in knowledge about weight management in osteoarthritis. Total score out of 70 possible points calculated from the responses to 14 Likert Scale (1-5) questions where higher values indicate higher confidence and lower values lower confidence in knowledge
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Timepoint [1]
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Change from baseline at 6 weeks post randomization
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Secondary outcome [1]
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Self-reported confidence in clinical skills for weight management for patients with osteoarthritis
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Assessment method [1]
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Measured using an expert-developed, customized self-reported questionnaire exploring physiotherapists' perceived confidence in clinical skills for weight management in osteoarthritis. Total score out of 45 possible points calculated from the responses to 9 Likert Scale (1-5) questions where higher values indicate higher confidence and lower values lower confidence in clinical skills.
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Timepoint [1]
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Change from baseline at 6 weeks post randomization
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Secondary outcome [2]
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Self-perceived competence in nutrition care to patients with chronic disease
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Assessment method [2]
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Measured using the NUTCOMP Questionnaire, a validated six section questionnaire (four sections scored, two unscored) developed to explore health care professional's perceived competence of the provision of nutrition care. Total score out of 175 possible points calculated from the responses to the Likert Scale (1-5) for each of the 35 questions, where higher values indicate higher confidence and lower values, lower confidence.
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Timepoint [2]
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Change from baseline at 6 weeks post randomization
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Secondary outcome [3]
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Weight stigmatized attitudes
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Assessment method [3]
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Measured by the Anti-Fat Attitudes questionnaire which comprises 13 statements about beliefs about weight (categorized under Dislike, Fear and Willpower) which respondents answer on a 10 point 0-9 Likert type scale, where 0 = very strongly disagree and 9 = very strongly agree. Total score calculated by response to each statement out of eight. The 3 subscales (dislike, fear and willpower) will also be reported.
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Timepoint [3]
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Change from baseline at 6 weeks post randomization
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Eligibility
Key inclusion criteria
* Currently registered with the Australian Health Practitioner Registry
* Have access to a computer with internet connection
* Willing to commit to completion of an 8-10 hour online training module if randomized to the intervention group
* Willing to refrain from participating in any weight management professional development activity external to the study for six weeks of intervention
* Able to give informed consent and to commit and participate fully in the assessment and evaluation procedures over the six week period.
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Minimum age
21
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* n/a
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Study design
Purpose of the study
Other
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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
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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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
6/10/2020
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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
15/12/2020
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Sample size
Target
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Accrual to date
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Final
80
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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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Other collaborator category [1]
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Other
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Name [1]
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National Health and Medical Research Council, Australia
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
A randomized controlled trial for which the primary objective is to evaluate the effects of an online training program on physiotherapist's self-reported confidence in knowledge about weight management for people with osteoarthritis. 80 physiotherapists will be recruited into the study and randomized to one of two arms a) online training program (access to training program for 6 weeks) or b) control group (no access to online training program during the study). Questionnaires will be completed by all participants at baseline, and again at the end of the 6 week intervention period. A biostatistician will analyse blinded, de-identified data.
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Trial website
https://clinicaltrials.gov/study/NCT04574804
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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, BAppSci
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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
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
No IPD will be shared
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04574804