OsteoarthritisNCT04574804
Effects of an Online Training Program for Physiotherapists About Weight Management for People With Osteoarthritis
A study testing Online training program in weight management for osteoarthritis in people with Osteoarthritis and Overweight and Obesity, run by University of Melbourne at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Overweight and Obesity
- What is being tested?
- Online training program in weight management for osteoarthritis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustralia
- Study dates
- 6 Oct 2020to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The Centre for Health Exercise and Sports Medicine at the University of Melbourne have developed a 6-module online training program designed to up-skill physiotherapists in weight management for osteoarthritis patients. This is a randomised controlled trial evaluating the effectiveness of the training program on physiotherapist's confidence in weight management for osteoarthritis patients. After providing informed consent and baseline data, physiotherapists will be randomized to either a) an online training program or b) control group. Those randomized to the online training group will be provided access to the a 6-module weight management training program and have six weeks to complete all the modules. Those randomized to the control group will receive no intervention. At baseline and six weeks, primary and secondary outcome measures will be completed in both groups.
The research question is: What are the effects of an online training program designed to up-skill physiotherapists in weight management for people with osteoarthritis? 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 participants will be recruited and randomization into the two study groups. To detect an effect size of 0.8 with 80% power and two sided significance level of 5%, 26 participants are required per group. Assuming a 35% loss to follow up, this will increase the same size to 40 per group (80 in total). The study will be conducted through The University of Melbourne. Participants will be able to access the training remotely in their own time and access all outcome measures online.
A biostatistician will analyse blinded, de-identified data. Analyses will be conducted with participants in assigned groups, with multiple imputation to account for missing data if required. Changes in self-reported confidence scores (primary outcome) will be compared between groups at 6 weeks using linear regression (with group as a factor) adjusting for baseline scores and the stratifying variables. Similar analyses will be conducted for secondary outcomes measured at baseline and 6 weeks. Process measures will be described in terms of mean (SD)/median (IQ range) or number (frequency). Standard diagnostic plots will be used to verify model assumptions.
If an imbalance is noted between groups for relevant baseline characteristics, sensitivity analyses will be conducted including these characteristics as covariates in the models assessing treatment effects.
The biostatistician will also conduct planned exploratory analyses to investigate potential moderators that could influence the effect of the training at 6 weeks. Pre-identified potential moderators include practice location (predominantly private vs predominantly public), baseline self rated confidence in weight management and years of clinical experience. To assess the moderation of the effect of randomised treatment group by the binary potential moderator (practice location), an interaction term between randomised group and the potential moderator, as well as terms for the randomised group and the potential moderator, will be included in the outcome regression model. To assess the moderation of the effect of randomised treatment group by continuous potential moderators (self rated confidence in weight management and years of clinical experience), the multivariable fractional polynomial interaction approach will be applied. This approach allows for nonlinear functional forms of the continuous potential moderator to be included in the regression model for outcomes, with the potential for separate nonlinear functional forms in each treatment group.
- Conditions
- Osteoarthritis, Overweight and Obesity
- Being tested
- Online training program in weight management for osteoarthritis
- Medical subject headings
- Osteoarthritis, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online training program in weight management for osteoarthritisOther
An evidence based online education training program for physiotherapists in weight management for osteoarthritis. Training modules cover the following topic areas:
- Overweight and obesity and osteoarthritis
- Overview of weight regulation, overweight and obesity
- Examining weight stigma in physiotherapy and personal beliefs about weight
- Communication approach for addressing weight management
- Interventions for weight management
- Health behaviour change support
These 6 e-learning modules comprise the online training program, access to which comprises the study intervention.
| Study group | Role | What they receive |
|---|---|---|
| online training program | Experimental | 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. Receives: Other: Online training program in weight management for osteoarthritis |
| control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported confidence in knowledge about weight management for patients with osteoarthritis
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
Measured: Change from baseline at 6 weeks post randomization
Secondary outcomes (3)
Self-reported confidence in clinical skills for weight management for patients with osteoarthritis
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.
Measured: Change from baseline at 6 weeks post randomization
Self-perceived competence in nutrition care to patients with chronic disease
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.
Measured: Change from baseline at 6 weeks post randomization
Weight stigmatized attitudes
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.
Measured: Change from baseline at 6 weeks post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start6 Oct 2020
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Responsible party
- Principal investigator, Kim Bennell, University of Melbourne
- Investigators
- Kim Bennell, PhD, BAppSci, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574804
- Sponsor's protocol ID
- UMelbourne
- Status last verified
- Jul 2021
- First submitted
- 22 Sep 2020
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Publications
Allison K, Jones S, Hinman RS, Briggs AM, Sumithran P, Quicke J, Holden M, Chiavaroli N, Crofts S, George E, Foster N, Bennell K. Effects of an Online Education Program on Physical Therapists' Confidence in Weight Management for People With Osteoarthritis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2023 Apr;75(4):835-847. doi: 10.1002/acr.24828. Epub 2022 Dec 12.
PubMed 34931477
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Online Training Program for Physiotherapists About Weight Management for People With Osteoarthritis
- ClinicalTrials.gov ID
- NCT04574804
- Acronym / sponsor ID
- UMelbourne
- Conditions
- Osteoarthritis, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Centre for Health Exercise and Sports Medicine at the University of Melbourne have developed a 6-module online training program designed to up-skill physiotherapists in weight management for osteoarthritis patients. This is a randomised controlled trial evaluating the effectiveness of the training program on physiotherapist's confidence in weight management for osteoarthritis patients. After providing informed consent and baseline data, physiotherapists will be randomized to either a) an online training program or b) control group. Those randomized to the online training group will be provided access to the a 6-module weight management training program and have six weeks to complete all the modules. Those randomized to the control group will receive no intervention. At baseline and six weeks, primary and secondary outcome measures will be completed in both groups.
The research question is: What are the effects of an online training program designed to up-skill physiotherapists in weight management for people with osteoarthritis? 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 participants will be recruited and randomization into the two study groups. To detect an effect size of 0.8 with 80% power and two sided significance level of 5%, 26 participants are required per group. Assuming a 35% loss to follow up, this will increase the same size to 40 per group (80 in total). The study will be conducted through The University of Melbourne. Participants will be able to access the training remotely in their own time and access all outcome measures online.
A biostatistician will analyse blinded, de-identified data. Analyses will be conducted with participants in assigned groups, with multiple imputation to account for missing data if required. Changes in self-reported confidence scores (primary outcome) will be compared between groups at 6 weeks using linear regression (with group as a factor) adjusting for baseline scores and the stratifying variables. Similar analyses will be conducted for secondary outcomes measured at baseline and 6 weeks. Process measures will be described in terms of mean (SD)/median (IQ range) or number (frequency). Standard diagnostic plots will be used to verify model assumptions.
If an imbalance is noted between groups for relevant baseline characteristics, sensitivity analyses will be conducted including these characteristics as covariates in the models assessing treatment effects.
The biostatistician will also conduct planned exploratory analyses to investigate potential moderators that could influence the effect of the training at 6 weeks. Pre-identified potential moderators include practice location (predominantly private vs predominantly public), baseline self rated confidence in weight management and years of clinical experience. To assess the moderation of the effect of randomised treatment group by the binary potential moderator (practice location), an interaction term between randomised group and the potential moderator, as well as terms for the randomised group and the potential moderator, will be included in the outcome regression model. To assess the moderation of the effect of randomised treatment group by continuous potential moderators (self rated confidence in weight management and years of clinical experience), the multivariable fractional polynomial interaction approach will be applied. This approach allows for nonlinear functional forms of the continuous potential moderator to be included in the regression model for outcomes, with the potential for separate nonlinear functional forms in each treatment group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| online training program | Experimental | Other: Online training program in weight management for osteoarthritisonline 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. |
| control group | No intervention | –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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online training program in weight management for osteoarthritisAn 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. | Other | online training program |
Primary outcome
Self-reported confidence in knowledge about weight management for patients with osteoarthritis
Time frame: Change from baseline at 6 weeks post randomization
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
3 secondary outcomes
Self-reported confidence in clinical skills for weight management for patients with osteoarthritis
Time frame: Change from baseline at 6 weeks post randomization
Self-perceived competence in nutrition care to patients with chronic disease
Time frame: Change from baseline at 6 weeks post randomization
Weight stigmatized attitudes
Time frame: Change from baseline at 6 weeks post randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
- Derived from this study: PubMed 34931477Allison K, Jones S, Hinman RS, Briggs AM, Sumithran P, Quicke J, Holden M, Chiavaroli N, Crofts S, George E, Foster N, Bennell K. Effects of an Online Education Program on Physical Therapists' Confidence in Weight Management for People With Osteoarthritis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2023 Apr;75(4):835-847. doi: 10.1002/acr.24828. Epub 2022 Dec 12.
- Individual participant dataSharing planned: No. No IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Bennell, PhD, BAppSci principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online training program in weight management for osteoarthritis in people with Osteoarthritis and Overweight and Obesity, run by University of Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported confidence in knowledge about weight management for patients with osteoarthritis (time frame: Change from baseline at 6 weeks post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04574804, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021.