Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001003268
Ethics application status
Approved
Date submitted
16/11/2009
Date registered
19/11/2009
Date last updated
28/06/2021
Date data sharing statement initially provided
28/06/2021
Date results provided
28/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Workplace POWER trial: a workplace weight loss program for male shift workers
Scientific title
The Workplace POWER trial: Feasibility and efficacy of an obesity treatment and healthy lifestyles program for overweight male shift workers
Secondary ID [1] 304636 0
Nil known
Universal Trial Number (UTN)
Trial acronym
POWER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 251997 0
Condition category
Condition code
Diet and Nutrition 252190 252190 0 0
Obesity
Public Health 252406 252406 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The duration of the intervention is 3 months. All participants will attend a face-to-face introductory session (60 minutes) led by the Chief Investigator in Oct-Nov 2009. The information session will cover standard weight control instruction relating to diet, physical activity and behaviour change strategies including self monitoring, goal setting and social support. All participants will be provided with a study handbook. Participants in the intervention group will receive additional behavioural procedures over the course of the 3 months via use of the online website www.calorieking.com.au to support the key strategies of self monitoring and social support. The initial face-to-face session for Intervention participants will also include a technical orientation session to familiarise and teach participants how to use the study website. The website allows submission of self-monitored energy expenditure and intake, weight and online group support. Participants will be instructed to submit daily diaries for the first month and be given the option of submitting daily or weekly thereafter. Their diaries will be reviewed (weekly in the 1st month; fortnightly in the 2nd month and monthly thereafter) and individualised feedback provided in the key areas of weight loss; diet (kilojoule intake, saturated fat, sodium and fibre) and physical activity (frequency, intensity, type and time). Participants can email the research team with questions. Men will attend the information sessions in crews or departments and be encouraged to help each other use the website. Men will also weigh in each month to track progress and the 'crew' with the greatest percentage weight loss will win a prize offered by workplace management (= $50 p/hd each). A prize will also be offered at 3 months from management.
Intervention code [1] 241407 0
Lifestyle
Intervention code [2] 241408 0
Behaviour
Comparator / control treatment
Wait-list control group for 6 months. The wait-list control group will be offered the intervention immediately following the 6 month follow-up assessment
Control group
Active

Outcomes
Primary outcome [1] 253066 0
Body weight (kg) was measured in light clothing, without shoes on a digital scale to 0.1kg (model CH-150kp, A&D Mercury Pty Ltd, Australia)
Timepoint [1] 253066 0
At baseline and at 3 and 6 months follow-up
Secondary outcome [1] 257892 0
Body Mass Index (BMI) - Height was measured to 0.1 cm using the stretch stature method and a stadiometer (VR High Speed Counter) (Harpenden/Holtain, Mentone Education Centre, Morrabin, Victoria). BMI was calculated using the standard equation (weight [kg]/height[m]2).
Timepoint [1] 257892 0
At baseline and at 3 and 6 months follow-up
Secondary outcome [2] 257893 0
Waist Circumference (cm) - Waist circumference was measured at two points (i) level with the umbilicus and (ii) at the narrowest point. Each measurement was recorded with a non-extensible steel tape (KDSF10-02, KDS Corporation, Osaka, Japan).
Timepoint [2] 257893 0
At baseline and at 3 and 6 months follow-up
Secondary outcome [3] 257894 0
Systolic and diastolic blood pressure were measured using a NISSEI/DS-105E digital electronic blood pressure monitor (Nihon Seimitsu Sokki Co. Ltd., Gunma, Japan) under standardized procedures
Timepoint [3] 257894 0
At baseline and at 3 and 6 months follow-up
Secondary outcome [4] 257895 0
Yamax SW700 pedometers (Yamax Corporation, Kumamoto City, Japan) were used to objectively measure physical activity. Participants were asked to wear pedometers for seven consecutive days and keep to their normal routine. At baseline assessments, participants were instructed on how to attach the pedometers (at the waist on the right hand side) and asked to remove the pedometers only when sleeping, when the pedometer might get wet (e.g. swimming, showering) or during contact sports. At the end of the day participants were instructed to record their steps and reset their pedometers to zero. Once they had completed seven days of monitoring, participants were instructed to place the pedometer and record sheet in the prepaid envelope provided and return to the research team.
Timepoint [4] 257895 0
Participants wore pedometers for 7 days at baseline and then again at 3 and 6 months follow-up
Secondary outcome [5] 257896 0
Dietary intake - measured using items from the Food Frequency Questionnaire from the Victorian Cancer Council and other supplementary questions + 4-item healthy eating practices
Timepoint [5] 257896 0
At baseline and at 3 and 6 months follow-up
Secondary outcome [6] 257897 0
Physical activity cognitions (social support, self efficacy, self management) using validated questionnaires
Timepoint [6] 257897 0
At baseline and at 3 and 6 months follow-up
Secondary outcome [7] 262292 0
Sleepiness - using the Epworth sleepiness scale
Timepoint [7] 262292 0
At baseline and at 3 and 6 months follow-up
Secondary outcome [8] 262293 0
Work productivity - using the the Work Limitations Questionnaire
Timepoint [8] 262293 0
At baseline and at 3 and 6 months follow-up
Secondary outcome [9] 262294 0
Perceived physical and mental health using the SF-12 questionnaire
Timepoint [9] 262294 0
At baseline and at 3 and 6 months follow-up
Secondary outcome [10] 262295 0
Absenteeism and injury rates were determined using work records
Timepoint [10] 262295 0
At baseline and at 3 and 6 months follow-up

Eligibility
Key inclusion criteria
Participants will be male staff at Tomago Aluminium Company Pty Limited who are overweight or obese (BMI between 25 and 40kg/m2)
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
History of major medical problems such as heart disease in the last 5 years, diabetes, or orthopaedic or joint problems that would be a barrier to physical activity. Participants with recent weight loss of 4.5kg or more or who are taking medications that might be affected by weight loss and particpants participating in other weight loss programs or without internet access will also be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects completed a consent form, an eligibility screen and a pre exercise screening questionnaire. Participants over 40 years were required to receive a doctor's clearance prior to commencement of the study.
Subjects were randomised in distinct 'crews' or departments that were matched based on profile and shift. All eligible crews were randomised into either intervention and control. Contamination was minimised as crews were matched so that they would not be working together at the same time.
To ensure concealment, the random allocation sequence was generated by a statistician and given to the chief investigator. The allocation sequence was concealed when enrolling crews.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation sequence was generated by a computer-based random number-producing algorithm. This method ensures an equal chance of allocation to each group.
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
Completed
Date of first participant enrolment
Anticipated
5/10/2009
Actual
5/10/2009
Date of last participant enrolment
Anticipated
Actual
15/10/2009
Date of last data collection
Anticipated
Actual
8/12/2020
Sample size
Target
120
Accrual to date
Final
110
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 243870 0
Other Collaborative groups
Name [1] 243870 0
Hunter Medical Research Institute (HMRI)
Country [1] 243870 0
Australia
Primary sponsor type
Individual
Name
A/Prof Philip Morgan
Address
School of Education
Faculty of Education and Arts
University Dve
University of Newcastle
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 251218 0
Individual
Name [1] 251218 0
A/Prof Robin Callister
Address [1] 251218 0
School of Biomedical Sciences
Faculty of Health
University Dve
University of Newcastle
Callaghan NSW 2308
Country [1] 251218 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243992 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 243992 0
Ethics committee country [1] 243992 0
Australia
Date submitted for ethics approval [1] 243992 0
Approval date [1] 243992 0
10/09/2009
Ethics approval number [1] 243992 0
H-2009-0256

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30274 0
Prof Philip Morgan
Address 30274 0
School of Education Faculty of Education and Arts University of Newcastle University Dve Callaghan NSW 2308
Country 30274 0
Australia
Phone 30274 0
+61 2 4921 7265
Fax 30274 0
Email 30274 0
[email protected]
Contact person for public queries
Name 13521 0
Philip Morgan
Address 13521 0
School of Education
Faculty of Education and Arts
University of Newcastle
University Dve
Callaghan NSW 2308
Country 13521 0
Australia
Phone 13521 0
+61 2 4921 7265
Fax 13521 0
+61 2 4921 7407
Email 13521 0
[email protected]
Contact person for scientific queries
Name 4449 0
Philip Morgan
Address 4449 0
School of Education
Faculty of Education and Arts
University of Newcastle
University Dve
Callaghan NSW 2308
Country 4449 0
Australia
Phone 4449 0
+61 2 4921 7265
Fax 4449 0
+61 2 4921 7407
Email 4449 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Please contact chief investigator [email protected] to discuss any data sharing requests.

Data will be available upon reasonable request.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12285Informed consent form  [email protected]
12286Study protocol  [email protected]
12287Statistical analysis plan  [email protected]
12288Ethical approval  [email protected]
12289Clinical study report  [email protected]



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.