Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000953235
Ethics application status
Approved
Date submitted
16/10/2009
Date registered
5/11/2009
Date last updated
9/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A cluster randomised controlled trial to assess the effectiveness of knowledge translation strategies for obesity prevention.
Scientific title
In Victorian local governments, does the implementation of knowledge translation strategies, compared to a comparison, increase use of evidence; access to, competence, confidence in using evidence, alter the influence evidence has in decisions, or alter organisational culture in using evidence to inform public health decisions.
Universal Trial Number (UTN)
Trial acronym
KT4LG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Use of evidence in local government public health planning and decision making. 251947 0
Condition category
Condition code
Public Health 252133 252133 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a facilitated program of knowledge translation strategies that comprises skills development, networking, personal contact and other related activities that will strengthen the organisational context to enable use of research evidence.

Councils in the intervention arm will receive a facilitated program in addition to access to evidence summaries. Councils in the comparison arm will receive evidence summaries alone.

The duration of the intervention will be 2 years.
Intervention code [1] 241365 0
Other interventions
Comparator / control treatment
Local government employees involved in public health planning but not receiving the intervention
Control group
Active

Outcomes
Primary outcome [1] 253011 0
Increase use of evidence. This will be assessed using a repeat of the baseline survey. The survey consists of a series of likert scale questions and will be administered online. This will be supplemented by key informant interviews and documentary analysis.
Timepoint [1] 253011 0
2 years post randomisation at completion of 2 year intervention
Secondary outcome [1] 257799 0
Increase access to research evidence. This will be assessed using a repeat of the baseline survey. The survey consists of a series of likert scale questions and will be administered online. This will be supplemented by key informant interviews and documentary analysis.
Timepoint [1] 257799 0
Post intervention (2years)
Secondary outcome [2] 257800 0
Increase competence in using evidence to inform decisions. This will be assessed using a repeat of the baseline survey. The survey consists of a series of likert scale questions and will be administered online. This will be supplemented by key informant interviews and documentary analysis.
Timepoint [2] 257800 0
Post intervention (2 years)
Secondary outcome [3] 257801 0
Increase confidence in understanding and use of research evidence. This will be assessed using a repeat of the baseline survey. The survey consists of a series of likert scale questions and will be administered online. This will be supplemented by key informant interviews and documentary analysis.
Timepoint [3] 257801 0
Post intervention (2years)
Secondary outcome [4] 257802 0
Increase organisational support for use of research evidence and evidence-informed decision making processes. This will be assessed using a repeat of the baseline survey. The survey consists of a series of likert scale questions and will be administered online. This will be supplemented by key informant interviews and documentary analysis.
Timepoint [4] 257802 0
Post intervention (2 years)

Eligibility
Key inclusion criteria
Employees in Victorian local government who participate in public health planning and decision-making (e.g. health promotion officer, social planner, environmental officer) i.e. some level of involvement with municipal public health plan development.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All 45 councils who completed a pre-trial baseline survey will be invited to participate in the trial by the program coordinator responsible for program implementation. Each intervention council will nominate a number of staff to particpate in the intervention. Stratified block randomisation will be used to randomly allocate councils to intervention or comparison groups. Strata will be defined by tertile of council annual budget. Once participation has been agreed and a memorandum of understanding has been signed, the program coordinator will email the trial manager with the name and annual budget of the council. The trial manager will then email the trial statistician with the stratum (but not name) of the council. The statistician will allocate the council (blind to its identity) to intervention or control on the basis of a randomisation sequence generated and held by the trial statistician and concealed to all other parties. The trial manager will log the group allocation on the trial database and inform the program coordinator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A seperate sequence will be generated for each of the 3 strata using a predetermined block size. Computer generated random numbers will be used to determine each sequence using the permutations satisfying the criteria of equal allocation to group within the predetermined block size.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243828 0
Government body
Name [1] 243828 0
National Health and Medical Research Council
Country [1] 243828 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The McCaughy Centre
Melbourne School of Population Health
Level 5 207 Bouverie St
The University of Melbourne
Vicotria 3010
Country
Australia
Secondary sponsor category [1] 251328 0
None
Name [1] 251328 0
Address [1] 251328 0
Country [1] 251328 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243955 0
Health Sciences Human Ethics Sub-Committee
Ethics committee address [1] 243955 0
The University of Melbourne
Victoria 3010
Ethics committee country [1] 243955 0
Australia
Date submitted for ethics approval [1] 243955 0
Approval date [1] 243955 0
17/06/2008
Ethics approval number [1] 243955 0
0722362

Summary
Brief summary
This project involves undertaking a cluster randomised controlled trial to examine the effectiveness of an organisational knowledge translation model in order to make recommendations about its applicability for public health decision-making settings.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30347 0
Address 30347 0
Country 30347 0
Phone 30347 0
Fax 30347 0
Email 30347 0
Contact person for public queries
Name 13594 0
Rebecca Armstrong
Address 13594 0
Senior Research Fellow
Public Health Evidence and Knowledge Translation Research Group
The McCaughey Centre, Melbourne School of Population Health
Faculty of Medicine, Dentisty and Health Sciences
Level 5, 207 Bouverie Street
The University of Mebourne
Victoria 3010
Country 13594 0
Australia
Phone 13594 0
+61 3 8344 3183
Fax 13594 0
Email 13594 0
armr@unimelb.edu.au
Contact person for scientific queries
Name 4522 0
Professor Elizabeth Waters
Address 4522 0
Jack Brockhoff Chair of Child Public Health
Coordinating Editor, Cochrane Public Health Review Group
The McCaughey Centre, Melbourne School of Population Health
Level 5, 207 Bouverie Street
The University of Melbourne
Vitoria, 3010
Country 4522 0
Australia
Phone 4522 0
+61 3 8344 3183
Fax 4522 0
Email 4522 0
ewaters@unimelb.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAn exploratory cluster randomised controlled trial of knowledge translation strategies to support evidence-informed decision-making in local governments (The KT4LG study).2011https://dx.doi.org/10.1186/1471-2458-11-34
EmbaseUnderstanding evidence: a statewide survey to explore evidence-informed public health decision-making in a local government setting.2014https://dx.doi.org/10.1186/s13012-014-0188-7
N.B. These documents automatically identified may not have been verified by the study sponsor.