Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000850875
Ethics application status
Approved
Date submitted
25/06/2012
Date registered
13/08/2012
Date last updated
24/06/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
New horizons for weight loss using mobile technologies
Scientific title
Acceptability and efficacy of a weight loss programme for overweight adults delivered via SMS and the Internet: a non-randomized pilot study
Secondary ID [1] 280200 0
TBF-MC11-001R (The Bupa Foundation)
Universal Trial Number (UTN)
Trial acronym
Horizon Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight / obesity 286137 0
Condition category
Condition code
Diet and Nutrition 286330 286330 0 0
Obesity
Public Health 287041 287041 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A prototype mHealth (mobile phone and internet-delivered) weight management programme. The programme will be delivered to participants for 8 weeks. Topics covered include nutritional and physical activity information and behavioural support. Text messages will be sent via mobile phone 3 times daily for the first 1-2 weeks, then twice daily for the remainder of the programme. Additionally, a few data collection question texts will be sent to participants. Participants are able to log on to the study website as they wish (this is not a requirement of the study). On the website, participants can view their individual progress compared with the group, as well as view and contribute to an online blog, and view other study resources (also provided hard copy to participants).
Intervention code [1] 284528 0
Behaviour
Intervention code [2] 285120 0
Lifestyle
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286800 0
Potential efficacy of mHealth programme as measured by weight change from baseline (using calibrated Salter scales).
Timepoint [1] 286800 0
12 weeks
Secondary outcome [1] 296679 0
Average recruitment rate
Timepoint [1] 296679 0
12 weeks
Secondary outcome [2] 296680 0
Pilot participant demographics (age, sex, ethnicity, income, household composition, area of residence) as compared with general population demographics. Participant demographic information will be self-reported and collected using a data collection form at the baseline visit.
Timepoint [2] 296680 0
Baseline visit
Secondary outcome [3] 296681 0
Participant retention rates (including withdrawal and loss to follow-up rates)
Timepoint [3] 296681 0
12 weeks
Secondary outcome [4] 296682 0
Feedback from participants receiving the programme. This data will be self-reported and collected using a data collection form at the 12 week visit.
Timepoint [4] 296682 0
12 weeks

Eligibility
Key inclusion criteria
Adults aged 18 years and older who have a BMI >= 25 kg/m2 and want to lose weight. Participants also need to have internet access and own a mobile phone capable of receiving texts (SMS).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who cannot read or understand English.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited using advertising in community venues such as libraries, community centres and GP practices, and local newspapers. Volunteers responding to advertisements will receive study information and an appointment to attend a baseline assessment where written informed consent will be obtained if the person is willing to take part.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A - non-randomised pilot study
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2012
Actual
3/09/2012
Date of last participant enrolment
Anticipated
Actual
28/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 4216 0
New Zealand
State/province [1] 4216 0

Funding & Sponsors
Funding source category [1] 284948 0
Charities/Societies/Foundations
Name [1] 284948 0
The Bupa Foundation
Country [1] 284948 0
United Kingdom
Primary sponsor type
University
Name
National Institute for Health Innovation, The University of Auckland
Address
Level 4, School of Population Health
Tamaki Campus
University of Auckland
261 Morrin Road
Glen Innes
Auckland
1072
Country
New Zealand
Secondary sponsor category [1] 283821 0
None
Name [1] 283821 0
Address [1] 283821 0
Country [1] 283821 0
Other collaborator category [1] 260649 0
University
Name [1] 260649 0
Queen Mary University of London
Address [1] 260649 0
Wolfson Institute of Preventive Medicine,
Mile End Road
London
E1 4NS
Country [1] 260649 0
United Kingdom
Other collaborator category [2] 260650 0
University
Name [2] 260650 0
Deakin University
Address [2] 260650 0
Centre for Physical Activity and Nutrition
221 Burwood Highway
Burwood
Melbourne
Victoria
3125
Country [2] 260650 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286962 0
Upper South B Regional Ethics Committee
Ethics committee address [1] 286962 0
c/- Ministry of Health
6 Hazeldean Road
Level 1
Montgomery Watson Building
Addington
Christchurch
8024
Ethics committee country [1] 286962 0
New Zealand
Date submitted for ethics approval [1] 286962 0
29/02/2012
Approval date [1] 286962 0
13/03/2012
Ethics approval number [1] 286962 0
URB/12/EXP/010

Summary
Brief summary
This feasibility study aims to develop and pre-test an mHealth weight loss programme. 50 volunteers will be recruited from the community and given the prototype programme for 8 weeks. The programme will use mobile phones and internet to provide information (e.g related to nutrition and physical activity) and behavioural strategies to achieve weight loss and maintain a long-term healthy lifestyle. The primary aim is to evaluate the potential effectiveness of the programme (as measured by weight loss at 12 weeks).
Trial website
Address will be: www.horizonstudy.org.nz
Trial related presentations / publications
Methods paper in press:
Wilma Waterlander, Robyn Whittaker; Hayden McRobbie; Enid Dorey; Kylie Ball; Ralph Maddison; Katie Myers Smith; David Crawford; Yannan Jiang; Yulong (Helen) Gu; Jo Michie; Cliona Ni Mhurchu. Development of an evidence-based mHealth weight management programme using a formative research process. JMIR mHealth and uHealth (in press).
Public notes

Contacts
Principal investigator
Name 33965 0
A/Prof Cliona Ni Mhurchu
Address 33965 0
National Institute for Health Innovation The University of Auckland Private Bag 92019 Auckland 1142
Country 33965 0
New Zealand
Phone 33965 0
+64, 9, 923 4494
Fax 33965 0
Email 33965 0
[email protected]
Contact person for public queries
Name 17212 0
Associate Professor Cliona Ni Mhurchu
Address 17212 0
National Institute for Health Innovation
The University of Auckland
Private Bag 92019
Auckland
1142
Country 17212 0
New Zealand
Phone 17212 0
+64, 9, 923 4494
Fax 17212 0
+64, 9, 373 1710
Email 17212 0
[email protected]
Contact person for scientific queries
Name 8140 0
Associate Professor Cliona Ni Mhurchu
Address 8140 0
National Institute for Health Innovation
The University of Auckland
Private Bag 92019
Auckland
1142
Country 8140 0
New Zealand
Phone 8140 0
+64, 9, 923 4494
Fax 8140 0
+64, 9, 373 1710
Email 8140 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
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