Effects of an Online Training Program for Physiotherapists About Weight Management for People With Osteoarthritis

July 7, 2021 updated by: Kim Bennell, University of Melbourne
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3010
        • University of Melbourne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Exclusion Criteria:

  • n/a

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change from baseline at 6 weeks post randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-reported confidence in clinical skills for 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 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.
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
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.
Change from baseline at 6 weeks post randomization
Weight stigmatized attitudes
Time Frame: Change from baseline at 6 weeks post randomization
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.
Change from baseline at 6 weeks post randomization

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Completion of training modules (process measure)
Time Frame: Throughout 6 week intervention period
Data will be collected through the learning management system platform. Completion of module will be categorized by passing end of module quiz with 100%. (Repeat attempts allowed). Number of modules completed reported.
Throughout 6 week intervention period
Usefulness of modules (process measure)
Time Frame: Throughout 6 week intervention period
Self-reported using bespoke 4-item questionnaire upon completion of each module. Measured using a 5-point Likert scale from 1= strongly disagree to 5 = strongly agree. Items scored individually, higher scores for each item represent positive impressions towards training
Throughout 6 week intervention period
Structure and content of modules (process measure)
Time Frame: Throughout 6 week intervention period
Impressions of module length and module content self reported using two custom questions, each assessed as one of 3 multi-choice options. Results for each multichoice option presented as a percentage for the 2 custom questions
Throughout 6 week intervention period
Time to complete each module (process measure)
Time Frame: Throughout 6 week intervention period
Self-reported upon completion of each individual module (built into module quiz). Reported in minutes
Throughout 6 week intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Melbourne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Health and Medical Research Council, Australia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kim Bennell, PhD, BAppSci, University of Melbourne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UMelbourne

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No IPD will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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