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Trial registered on ANZCTR


Registration number
ACTRN12610000197033
Ethics application status
Approved
Date submitted
3/03/2010
Date registered
8/03/2010
Date last updated
4/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Development and evaluation of novel strategies to enhance Internet-based weight loss and weight maintenance programs
Scientific title
A randomised trial in overweight and obesity men and women, to evaluate the effectiveness of novel strategies to enhance Internet-based weight loss and maintenance of lost weight
Secondary ID [1] 1462 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 256808 0
Condition category
Condition code
Public Health 256958 256958 0 0
Other public health
Diet and Nutrition 257053 257053 0 0
Obesity
Cardiovascular 257054 257054 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An enhanced version of a standard 12 week online weight management program.
Standard online program: these subjects will have free access to a web-based weight loss program for the duration of the project. This online program has the following features:
Food and physical activity diaries and search engines to facilitate entry of food
Individualised calorie targets
Daily and weekly calculations of energy balance and nutrients
Weekly menu plan and grocery list
Weekly physical activity plan
Monitoring of body weight, waist and hips

The Enhanced online program:
These subjects will have free access to the standard online program. In addition, this group will be provided with automated (computer-generated) personalised feedback based on their diet and physical activity diaries, their use or lack of use of the standard website features, and the level of success of their weight loss.
Intervention code [1] 256013 0
Lifestyle
Comparator / control treatment
The initial 3 month waitlist control group is a separate control arm. These subjects attend an initial baseline assessment but receive no intervention. They then return for re-assessment of the same baseline variables after a 3 month waiting period and then are re-randomised to either of the 2 active intervention arms described above, i.e. a 12 week online weight loss program in either the standard or enhanced versions described above.
Control group
Active

Outcomes
Primary outcome [1] 257838 0
Change in body mass index (BMI) . BMI is calculated from height and weight (kg/m squared).
Height is measured to 0.1 cm on a portable Holtain stadiometer.
Weight is measured using calibrated digital scales that measure to 0.1 kg.
Timepoint [1] 257838 0
Baseline, 3 months, 6 months, 18 months,
Secondary outcome [1] 263254 0
Waist circumference is measured to 0.1 cm using a non-extensible steel tape.
Timepoint [1] 263254 0
Baseline, 3 months, 6 months, 18 months
Secondary outcome [2] 263255 0
Steps per day measured by pedomter.
Timepoint [2] 263255 0
Baseline, 3 months, 6 months, 18 months
Secondary outcome [3] 263256 0
Energy intake, measured by Food Frequency Questionnaire (FFQ)
Timepoint [3] 263256 0
Baseline, 3 months, 6 months, 18 months
Secondary outcome [4] 263475 0
Blood lipids, glucose and insulin will be measured using standard clinical chemistry procedures in a National Association of Testing Laboratories (NATA) accredited pathology laboratory
Timepoint [4] 263475 0
Baseline, 3 months, 6 months, 18 months

Eligibility
Key inclusion criteria
a history of major medical problems such as heart disease or diabetes; orthopaedic or joint problems that would be a barrier to physical activity such as walking; recently lost 4.5 kg or more in weight; are taking medications that might be affected by weight loss or affect weight loss.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Have a Body Mass Index (BMI) between 25 and 40; Agree to not participate in other weight loss programs during the study; Pass a health-screening questionnaire and are available for assessment sessions; Have access to a computer with e-mail and Internet facilities

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)
Once enrolled and subject data was collected each subject received the next envelope in the sequence, based on their stratified BMI and gener group. Envelopes were prepared ahead of time, sealed and distributed by a researcher not involved in data measurement. Subjects were instructed to not open their allocation envelope until they returned home.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects were randomised to one of the three treatment groups using a stratified randomised block design.
Subjects were stratified by gender and category of body mass index (25 to <30; 30 to <35 or 35 to < 40) and
blocks were of variable length (either 3 or 6).

In the second randomisation process for randomisation to "maintenance of lost weight" group, the statistician also needed to stratify by treatment group in phase I.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects are re-randomised at the end of the weight loss phase to one of two "maintenace of lost weight" arms.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/10/2009
Actual
19/09/2009
Date of last participant enrolment
Anticipated
Actual
7/12/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
260
Accrual to date
Final
309
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 2619 0
2308

Funding & Sponsors
Funding source category [1] 256598 0
Government body
Name [1] 256598 0
ARC Linkage Project and Partner organisation
Country [1] 256598 0
Australia
Funding source category [2] 256599 0
Government body
Name [2] 256599 0
ARC
Country [2] 256599 0
Australia
Primary sponsor type
Government body
Name
ARC
Address
1st Floor, 8 Brindabella Circuit
Brindabella Business Park
CANBERRA AIRPORT ACT 2609
Country
Australia
Secondary sponsor category [1] 255892 0
Commercial sector/Industry
Name [1] 255892 0
SP Health Co Pty Ltd
Address [1] 255892 0
65 Walker St
North Sydney
NSW 2060
Country [1] 255892 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258628 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 258628 0
Ethics committee country [1] 258628 0
Australia
Date submitted for ethics approval [1] 258628 0
Approval date [1] 258628 0
10/09/2009
Ethics approval number [1] 258628 0
H- 2009-0245

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

Contacts
Principal investigator
Name 30838 0
Prof Clare Collins
Address 30838 0
Priority Research Centre in Physical Activity and Nutrition
Rm 301 Advanced Technology Building
The University of Newcastle
University Drive, Callaghan
NSW 2308 Australia
Country 30838 0
Australia
Phone 30838 0
+61 2 49215646
Fax 30838 0
Email 30838 0
clare.collins@newcastle.edu.au
Contact person for public queries
Name 14085 0
Associate Professor Clare Collins
Address 14085 0
Priority Research Centre in Physical Activity and Nutrition
Rm 301 Advanced Technology Building
The University of Newcastle
University Drive, Callaghan
NSW 2308 Australia
Country 14085 0
Australia
Phone 14085 0
+61 2 49215646
Fax 14085 0
+61 2 49217053
Email 14085 0
clare.collins@newcastle.edu.au
Contact person for scientific queries
Name 5013 0
Clare Collins
Address 5013 0
Priority Research Centre in Physical Activity and Nutrition
Rm 301 Advanced Technology Building
The University of Newcastle
University Drive, Callaghan
NSW 2308 Australia
Country 5013 0
Australia
Phone 5013 0
+61 2 49215646
Fax 5013 0
+61 2 49217053
Email 5013 0
clare.collins@newcastle.edu.au

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
EmbaseA 12-week commercial web-based weight-loss program for overweight and obese adults: randomized controlled trial comparing basic versus enhanced features.2012https://dx.doi.org/10.2196/jmir.1980
EmbaseEfficacy of standard versus enhanced features in a Web-based commercial weight-loss program for obese adults, part 2: randomized controlled trial.2013
EmbaseEfficacy of standard versus enhanced features in a Web-based commercial weight-loss program for obese adults, part 2: randomized controlled trial.2013https://dx.doi.org/10.2196/jmir.2626
EmbaseEnhancement of Self-Monitoring in a Web-Based Weight Loss Program by Extra Individualized Feedback and Reminders: Randomized Trial.2016https://dx.doi.org/10.2196/jmir.4100
EmbaseComparison of Australian recommended food score (ARFS) and plasma carotenoid concentrations: A validation study in adults.2017https://dx.doi.org/10.3390/nu9080888
EmbaseThe comparative validity of a brief diet screening tool for adults: The Fruit And Vegetable VAriety index (FAVVA).2019https://dx.doi.org/10.1016/j.clnesp.2018.10.007
N.B. These documents automatically identified may not have been verified by the study sponsor.