Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000081910
Ethics application status
Approved
Date submitted
20/01/2011
Date registered
21/01/2011
Date last updated
9/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
ManUp Gladstone Project: an Internet and Mobile Phone Delivered Physical Activity and Nutrition Intervention.
Scientific title
Efficacy Testing of an Internet and Mobile Phone Delivered Physical Activity and Nutrition Intervention for Men aged 35-54 years.
Secondary ID [1] 253453 0
None
Universal Trial Number (UTN)
U1111-1119-1840
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The aim of this research is to test the efficacy of an internet and mobile phone delivered physical activity and nutrition intervention in a two-armed randomised control trial for men aged 35-54 years. 261003 0
Condition category
Condition code
Public Health 259140 259140 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be recruited and randomised into two intervention groups with the help of various partner organisations that form part of the community consortium and local media.

The two intervention groups will consist of the 'Control' group and the 'IT' (Information Technology) group.

The 'Control' group will receive a print logbook with all ManUp intervention material.

Participants in the 'IT' Group will be provided with access to both the website and the mobile phone application. Participants are not required to have a mobile phone that is compatible with the application that we have developed, however in that case they will not be able to access this 'extra' component of the intervention. Participants with access to the IT group will receive regular challenge progress emails and SMS.

Dependant on the length of challenges that participants choose, they will either receive an email/SMS weekly or fortnightly. Challenges opt from three to twelve weeks in length, and participants can complete as many challenges as they like during the duration of the project.
Intervention code [1] 257895 0
Lifestyle
Comparator / control treatment
Participants in the 'Control' group will not have access to an internet or mobile intervention, receiving only print-based information only.

A sub-sample group will comprise of both 'Control' and 'IT' group members. Those in the sub-sample will have objective measures taken of their height and weight.
Control group
Active

Outcomes
Primary outcome [1] 261991 0
Participants wll be asked to complete the following survey instruments and have the following measurements taken at each data collection time point.

Physical Activity Questionnaire
Nutrition/Food Questionnaire
Physical Activity Literacy Questionnaire
Nutrition Literacy Questionnaire
Timepoint [1] 261991 0
0, 3 and 12 months.
Secondary outcome [1] 268924 0
Phase 1 - Control Group and IT Group.

All individuals will be provided with a detailed information sheet and an informed consent form. They will have their data recorded at a time convenient for them. Participants will complete the survey instruments (Surveys mentioned in Primary Outcome 1) and will have their height and weight measured at each time point.

Phase 2 - Sub-sample group.

All individuals will be fitted with an accelerometer and will have objective measures taken of their height and weight whilst completing the same intervention as Phase 1 participants.
Timepoint [1] 268924 0
0, 3 and 12 months.

Eligibility
Key inclusion criteria
Participants will be screened by a member of the research team either in person, phone conversation or electronic communication and meet the following criteria to be included in the study.

- Male
- Aged 35-54 years
- Own a mobile phone
- Have regular access to the internet
- Not have a condition where physical activity is contraindicated
- Have completed a pre-exercise screening assessment and have a low or moderate risk for exercise related complications, or if high risk have approval from medical professional to participate in exercise. (http://sma.org.au/wp-content/uploads/2009/05/new_pre_screening.pdf)

Participants will be deemed healthy volunteers by completing the pre-exercise screening assessment.
Minimum age
35 Years
Maximum age
54 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Female
- Outside of 35-54 year age bracket
- Without a mobile phone
- Without regular access to the internet
- Have a condition where physical activity is contraindicated

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)
Interested participants are asked to complete an online registration form which details whether or not they are eligible, contact information and how they found out about ManUp Gladstone.

Once eligibility is assessed, participants are enrolled into the project and assigned to an intervention group.

Those who are in the sub-sample group are asked to visit our ManUp Gladstone Project Officer for an Actigraph appointment. Those not in the sub-sample are sent an e-mail asking them to complete an online survey, completing the first stage of the intervention.

Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization.com was used to determine how the 504 participants would be allocated to the two intervention groups, as well as a the small sub-sample 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
Recruiting
Date of first participant enrolment
Anticipated
25/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
504
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3590 0
4680

Funding & Sponsors
Funding source category [1] 258371 0
Government body
Name [1] 258371 0
Queensland Health
Country [1] 258371 0
Australia
Primary sponsor type
University
Name
CQUniversity Australia
Address
Institute for Health and Social Science Research
CQUniversity Australia
Rockhampton Queensland 4702
Country
Australia
Secondary sponsor category [1] 257520 0
University
Name [1] 257520 0
University Of Western Sydney
Address [1] 257520 0
School of Biomedical and Health Sciences
Campbelltown Campus
Penrith South DC NSW 1797
Country [1] 257520 0
Australia
Other collaborator category [1] 251780 0
Government body
Name [1] 251780 0
CSIRO
Address [1] 251780 0
The Australian E-Health Research Centre
CSIRO Human Nutrition
PO BOX 10041
Adelaide BC SA 5000

Level 7 - UQ CCR Building 71/918
Royal Brisbane and Women's Hospital
HERSTON Q 4029
Country [1] 251780 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260349 0
Human Research Ethics Committee
Ethics committee address [1] 260349 0
Office Of Research
Building 32
CQUniversity
Rockhampton Queensland 4701
Ethics committee country [1] 260349 0
Australia
Date submitted for ethics approval [1] 260349 0
Approval date [1] 260349 0
22/09/2010
Ethics approval number [1] 260349 0
H10/07-131

Summary
Brief summary
ManUp is a physical activity and healthy eating project for men and is conducted in the Gladstone region. In this project we will use the Internet to help men to achieve their physical activity and healthy eating goals and challenges.
Trial website
www.recruit.manup.org.au
www.manup.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32120 0
Address 32120 0
Country 32120 0
Phone 32120 0
Fax 32120 0
Email 32120 0
Contact person for public queries
Name 15367 0
Mitch Duncan
Address 15367 0
Building 18
CQUniversity Australia
Rockhampton Queensland 4701
Country 15367 0
Australia
Phone 15367 0
+61 7 49306977
Fax 15367 0
Email 15367 0
[email protected]
Contact person for scientific queries
Name 6295 0
Mitch Duncan
Address 6295 0
Building 18
CQUniversity Australia
Rockhampton Queensland 4701
Country 6295 0
Australia
Phone 6295 0
+61 7 49306977
Fax 6295 0
Email 6295 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
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of a web- and mobile phone-based intervention to promote physical activity and healthy eating in middle-aged males: randomized controlled trial of the ManUp study.2014https://dx.doi.org/10.2196/jmir.3107
N.B. These documents automatically identified may not have been verified by the study sponsor.