Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001496404
Ethics application status
Approved
Date submitted
23/10/2016
Date registered
28/10/2016
Date last updated
22/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of serial anthropometric measurements and motivational text messages on weight reduction amongst workers
Scientific title
Effect of serial anthropometric measurements and motivational text messages on weight reduction amongst workers
Secondary ID [1] 290370 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 300670 0
cardiovascular risk 300671 0
sedentary lifestyle 300672 0
Condition category
Condition code
Diet and Nutrition 300519 300519 0 0
Obesity
Cardiovascular 300520 300520 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is examining the effect of serial measurements of waist-to-hip ratios combined with motivational text messages to improve weight reduction in workers in Australia.

Participants will require a mobile phone in order to receive weekly reminder text messages for serial measurements over 8 weeks. Participants will be asked to text back their hip/waist ratios on a weekly basis. Messaging software will only track if people respond.

Participants will also receive text messages every 2 days over 8 weeks with informative messages regarding healthy eating, regular exercise and goal setting. We aim to study the effect of regular encouragement on health.
Intervention code [1] 296192 0
Lifestyle
Intervention code [2] 296193 0
Behaviour
Comparator / control treatment
The control will receive fortnightly text messages for 8 weeks with informative but not motivational messages regarding healthy lifestyle guidelines. They will not receive reminder messages for serial measurements and are not asked to take weekly measurements.
Control group
Active

Outcomes
Primary outcome [1] 299944 0
Change between initial and final waiste-to-hip measurements in centimeters. These will be assessed by an pre and post study survey via Survey Monkey.
Timepoint [1] 299944 0
8 weeks post commencement of intervention.
Secondary outcome [1] 328619 0
Change in initial and final weight measurement in kilograms. This will be measured by pre and post survey via Survey Monkey.
Timepoint [1] 328619 0
8 weeks post commencement of intervention.
Secondary outcome [2] 328620 0
Change in initial and final self-perceived health rating. This will be measured by pre and post survey via Survey Monkey.
Timepoint [2] 328620 0
8 weeks pre and post commencement of intervention.
Secondary outcome [3] 328621 0
Change in initial and final number of serves of fruit and vegetables consumed daily. This will be measured by pre and post survey via Survey Monkey.
Timepoint [3] 328621 0
8 weeks post commencement of intervention
Secondary outcome [4] 328622 0
Change in initial and final time spent doing physical activity in minutes. This will be measured by pre and post survey via Survey Monkey.
Timepoint [4] 328622 0
8 weeks post commencement of intervention
Secondary outcome [5] 328737 0
Burnout. This will be measured by pre and post survey via Survey Monkey.
Timepoint [5] 328737 0
8 weeks post commencement of intervention
Secondary outcome [6] 328738 0
Workability. This will be measured by pre and post survey via Survey Monkey.
Timepoint [6] 328738 0
8 weeks post commencement of intervention
Secondary outcome [7] 328739 0
Productivity.This will be measured by pre and post survey via Survey Monkey.
Timepoint [7] 328739 0
8 weeks post commencement of intervention

Eligibility
Key inclusion criteria
Over 18 years of age
Currently employed
Access to a mobile phone
Not on medication that causes weight gain
Not currently on a weight loss program
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those that withdraw their consent

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/11/2016
Actual
31/10/2016
Date of last participant enrolment
Anticipated
Actual
11/01/2017
Date of last data collection
Anticipated
Actual
7/03/2017
Sample size
Target
200
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 294758 0
University
Name [1] 294758 0
University Center for Rural Health, Western Sydney University
Country [1] 294758 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Western Sydney University
Locked bag 1797
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 293607 0
None
Name [1] 293607 0
Address [1] 293607 0
Country [1] 293607 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296169 0
Western Sydney Human Research Ethics Committee
Ethics committee address [1] 296169 0
Ethics committee country [1] 296169 0
Australia
Date submitted for ethics approval [1] 296169 0
17/10/2016
Approval date [1] 296169 0
20/10/2016
Ethics approval number [1] 296169 0
H11327

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

Contacts
Principal investigator
Name 69842 0
Dr Sabrina Pit
Address 69842 0
University Centre for Rural Health, Western Sydney University, 61 Uralba Street, Lismore, NSW, 2480
Country 69842 0
Australia
Phone 69842 0
+61266207570
Fax 69842 0
Email 69842 0
[email protected]
Contact person for public queries
Name 69843 0
Sabrina Pit
Address 69843 0
University Centre for Rural Health, Western Sydney University, 61 Uralba Street, Lismore, NSW, 2480
Country 69843 0
Australia
Phone 69843 0
+61266207570
Fax 69843 0
Email 69843 0
[email protected]
Contact person for scientific queries
Name 69844 0
Sabrina Pit
Address 69844 0
University Centre for Rural Health, Western Sydney University, 61 Uralba Street, Lismore, NSW, 2480
Country 69844 0
Australia
Phone 69844 0
+61266207570
Fax 69844 0
Email 69844 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.