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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
Date last updated
9/07/2021

Titles & IDs
Public title
Effects of an Online Training Program for Physiotherapists About Weight Management for People With Osteoarthritis
Scientific title
Effects of an Online Training Program for Physiotherapists About Weight Management for People With Osteoarthritis
Secondary ID [1] 0 0
UMelbourne
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Overweight and Obesity 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Self-reported confidence in knowledge about weight management for patients with osteoarthritis
Timepoint [1] 0 0
Change from baseline at 6 weeks post randomization
Secondary outcome [1] 0 0
Self-reported confidence in clinical skills for weight management for patients with osteoarthritis
Timepoint [1] 0 0
Change from baseline at 6 weeks post randomization
Secondary outcome [2] 0 0
Self-perceived competence in nutrition care to patients with chronic disease
Timepoint [2] 0 0
Change from baseline at 6 weeks post randomization
Secondary outcome [3] 0 0
Weight stigmatized attitudes
Timepoint [3] 0 0
Change from baseline at 6 weeks post randomization

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.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* n/a

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/12/2020
Sample size
Target
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3010 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04574804
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kim Bennell, PhD, BAppSci
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04574804