Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612001171808
Ethics application status
Approved
Date submitted
2/11/2012
Date registered
6/11/2012
Date last updated
16/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Intervention Whyalla: Workplace health promotion for improving metabolic health and health awareness
Scientific title
The effect of health promotion strategies targeting physical activity, diet, sleep and smoking in a regional Australian mining and steelmaking company on waist girth and glycated haemoglobin (HbA1c) trajectories: a multiple baseline interrupted time-series study
Secondary ID [1] 281490 0
Nil
Universal Trial Number (UTN)
U1111-1136-6167
Trial acronym
iWhyalla
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal obesity 287756 0
Type 2 Diabetes Mellitus 287757 0
Cardiometabolic disease 287758 0
Condition category
Condition code
Public Health 288099 288099 0 0
Health promotion/education
Diet and Nutrition 288100 288100 0 0
Obesity
Metabolic and Endocrine 288101 288101 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a multi-strategy intervention. Firstly, type 2 diabetes screening using HbA1c measured at point-of-care with immediate referral to general practitioners when HbA1c is 6.5% (48 mmol/mol) or greater. Secondly, Health promotion strategies delivered by peer champions (trained co-workers) to work units during normal weekly worktime meetings (2hr/week over 8 weeks). The strategies include education practical skill development; flexible goal setting; action planning and self-monitoring (attending to theoretical constructs of behaviour: knowledge; intentions, attitudes, subjective norms, perceived efficacy (Theory of Planned Behaviour); perceived susceptibility, perceived severity, perceived benefits, perceived barriers (Health Belief Model); collective efficacy (Social Learning Theory). Behaviours focussed on are in the causal pathway to abdominal obesity, type 2 diabetes and diabetic control: physical inactivity, low fruit and vegetable consumption, high sugar sweeted beverage consumption, high alcohol consumption, short sleep and smoking.
Peer champions will be trained by an chronic disease self-management Trainer-trainer accredited in both Stanford and Flinders models. The recruitment and training of peer champions is a key component of readiness to adopt the intervention within a workgroup.
Thirdly, during the health promotion eduction and in response to process and outcomes data collected during the study, workplace environmental intervention strategies will be developed.
Although the overall duration of this intervention is not set, as the timing of adoption is not prescribed, we expect to run this study initially for 20 months.
Intervention code [1] 286000 0
Early detection / Screening
Intervention code [2] 286001 0
Prevention
Intervention code [3] 286002 0
Behaviour
Comparator / control treatment
The comparator of work units who have adopted the intervention are the work units who have not yet adopted the intervention (but who would intend to once ready); similar to having multiple 'waitlist control' groups in a clinical trial. This study is a multiple baseline time-series design, so intervention groups (work units) are feely allowed to adopt the intervention as they become ready Assuming the classic Rogers theory of innovation adoption is upheld, adoption of the intervention by work groups will occur progressively across the organisation. Rather than collection of two waves of data (pre/post) as is typical in conventional randomised community trial designs, outcomes data are collected multiple times on the same schedule across all groups before, during and after the intervention. The resulting time series will be tested for changes in trends associated with the timing, nature and intensity of intervention strategies within each group.
Control group
Active

Outcomes
Primary outcome [1] 288303 0
Mean HbA1c (% and mmol/mol) as measured at 'point-of-care' using the DCA Vantage (Siemens Healthcare Diagnostics, Deerfield, IL).
Timepoint [1] 288303 0
Every 4 to 6 months over 20 months determined based on resource availability and organisational requirements.
Primary outcome [2] 288304 0
Mean waist girth as measured according to International Society for the Advancement of Kinanthropometry (ISAK) standards, using Lufkin W606PM steel girth tapes.
Timepoint [2] 288304 0
Every 4 to 6 months over 20 months determined based on resource availability and organisational requirements.
Primary outcome [3] 288305 0
Diabetes incidence as assessed by self reported new diagnoses of type 2 diabetes
Timepoint [3] 288305 0
Every 3 months over 20 months
Secondary outcome [1] 299792 0
Blood pressure (systolic and diastolic) ans measured by automated sphygmomanometry (model HEM-7221, Omron Healthcare, Kyoto, Japan)
Timepoint [1] 299792 0
Every 4 to 6 months over 20 months determined based on resource availability and organisational requirements.
Secondary outcome [2] 299793 0
Steps per day as measured by pedomter-accelerometer (GSensor model GS2026)
Timepoint [2] 299793 0
daily over 20 months
Secondary outcome [3] 299794 0
Physical activity (total; leisure time; dometsic and gardening (yard); work-related; transport-related) as measured by the International Physical Activity Questionnaire (IPAQ).
Timepoint [3] 299794 0
Every 3 months over 20 months
Secondary outcome [4] 299795 0
Occupational activity domains (sitting; standing; walking; sleeping/napping heavy labour/physically demanding tasks) as measured in minutes per week using a modified version of the Occpational Sitting and Physical Activity Questionnaire (Chau et al. 2012. Med. Sci. Sports Exerc.)
Timepoint [4] 299795 0
Every 3 months over 20 months
Secondary outcome [5] 299796 0
Sleep duration (hours) as measured by the Pittsburg Sleep Quality Index (PSQI)
Timepoint [5] 299796 0
Every 3 months over 20 months
Secondary outcome [6] 299797 0
Daytime dysfunction as measured by the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [6] 299797 0
Every 3 months over 20 months
Secondary outcome [7] 299798 0
Fruit and vegetable consumptions as measured by self reported number of serves per day using standard serving size prompts.
Timepoint [7] 299798 0
Every 3 months over 20 months
Secondary outcome [8] 299799 0
Avergage alcohol consumption (grams/day) as measured by a set of alcoholic beverage consumption questions modified from the Cancer Council of Victoria Dietary Questionnaire (Version 3.1)
Timepoint [8] 299799 0
Every 3 months over 20 months
Secondary outcome [9] 299800 0
Average sugar sweetened beverage consumption (kj of carbohydrate from beverages) as measured by a set of beverage consumption questions modified from the Cancer Council of Victoria Dietary Questionnaire (Version 3.1)
Timepoint [9] 299800 0
Every 3 months over 20 months
Secondary outcome [10] 299801 0
Smoking cessation as measured by the question: Are you currently a smoker?
Timepoint [10] 299801 0
Every 3 months over 20 months
Secondary outcome [11] 299802 0
habitual smoking reduction as measure by the question: how many cigarettes in a day do you now smoke? (from the Fagerstrom Test for nictine Dependence).
Timepoint [11] 299802 0
Every 3 months over 20 months
Secondary outcome [12] 299803 0
Workplace incident rate as determined through routine organisational reporting procedures
Timepoint [12] 299803 0
Quarterly from 2004 to 2015
Secondary outcome [13] 299804 0
Workplace injury rate as determined through routine organisational reporting procedures
Timepoint [13] 299804 0
Quarterly from 2004 to 2015
Secondary outcome [14] 299805 0
Workplace health-related abstenteeism rate as determined through routine organisational reporting procedures
Timepoint [14] 299805 0
Quarterly from 2004 to 2015

Eligibility
Key inclusion criteria
Employees of Onesteel Whyalla Steelworks and Arrium Mining in Whyalla, South Australia and surrounding mining sites.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This study is a multiple baseline interrupted time-series design. This includes parallel outcome monitoring but progressively adopted intervention over time accross the groups.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286265 0
Government body
Name [1] 286265 0
Australian Government Department of Health and Ageing (University Department of Rural Health Program)
Country [1] 286265 0
Australia
Funding source category [2] 286266 0
Commercial sector/Industry
Name [2] 286266 0
Arrium Ltd (Onesteel Whyalla Steelworks & Arrium Mining)
Country [2] 286266 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 285066 0
None
Name [1] 285066 0
Address [1] 285066 0
Country [1] 285066 0
Other collaborator category [1] 277155 0
Commercial sector/Industry
Name [1] 277155 0
Onesteel Whyalla Steelworks/Arrium Mining
Address [1] 277155 0
Port Augusta Road
Whyalla SA 5600
Country [1] 277155 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288340 0
University of South Australia human Research Ethics Committee
Ethics committee address [1] 288340 0
GPO Box 2471
Adelaide SA 5001
Ethics committee country [1] 288340 0
Australia
Date submitted for ethics approval [1] 288340 0
Approval date [1] 288340 0
08/10/2012
Ethics approval number [1] 288340 0
29326

Summary
Brief summary
The purpose of this study is to prevent the current excess of abdominal obesity from translating into an excess of diabetes in the future. We aim to begin this objective through a workplace health promotion program in the major employer in the city as working age has been shown to be the most cost-effective period of the lifecourse for behavioural interventions in obesity. Through personal and environmentl strategies we aim to promote healthful trajectories in: (a) behaviour (physical activity, sleep, diet and smoking reduction); (b) waist girth and blood sugar; (c) diabetes detection and management; (d) workplace injuries and productivity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34913 0
Address 34913 0
Country 34913 0
Phone 34913 0
Fax 34913 0
Email 34913 0
Contact person for public queries
Name 18160 0
Matthew T Haren
Address 18160 0
Social Epidemiology and Evaluation Research Group
School of Population Health
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 18160 0
Australia
Phone 18160 0
+61 8 83021827
Fax 18160 0
+61 8 83022603
Email 18160 0
[email protected]
Contact person for scientific queries
Name 9088 0
Matthew T Haren
Address 9088 0
Social Epidemiology and Evaluation Research Group
School of Population Health
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 9088 0
Australia
Phone 9088 0
+61 8 83021827
Fax 9088 0
+61 8 83022603
Email 9088 0
[email protected]

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
No additional documents have been identified.