ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Condition category

Condition code

Public Health

Other public health

Diet and Nutrition

Obesity

Cardiovascular

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]

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]

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]

Baseline, 3 months, 6 months, 18 months,

Secondary outcome [1]

Waist circumference is measured to 0.1 cm using a non-extensible steel tape.

Timepoint [1]

Baseline, 3 months, 6 months, 18 months

Secondary outcome [2]

Steps per day measured by pedomter.

Timepoint [2]

Baseline, 3 months, 6 months, 18 months

Secondary outcome [3]

Energy intake, measured by Food Frequency Questionnaire (FFQ)

Timepoint [3]

Baseline, 3 months, 6 months, 18 months

Secondary outcome [4]

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]

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]

2308

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

ARC Linkage Project and Partner organisation

Address [1]

ARC Linkage grant with Partner Organisation, SP Health Co Pty Ltd
Walker St, North Sydney
NSW 2060

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

ARC

Address [2]

ARC postal address:
GPO Box 2702
Canberra ACT 2601
Australia

Country [2]

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]

Commercial sector/Industry

Name [1]

SP Health Co Pty Ltd

Address [1]

65 Walker St
North Sydney
NSW 2060

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Newcastle Human Research Ethics Committee

Ethics committee address [1]

Chancellery Building
University Drive
Callaghan 
NSW 2308

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

10/09/2009

Ethics approval number [1]

H- 2009-0245

Summary

Brief summary

Obesity is at epidemic proportions and affects over 7 million Australians with an estimated economic cost of $4 billion. Online weight management programs are widely accessible and have the potential to be a cost effective treatment option. However, the effectiveness of online weight management programs is largely undetermined and there has been no research to date to establish which online program features enhance weight loss outcomes. Using a Randomised Controlled Trial design, this study will provide evidence about the effectiveness of treating overweight and obese people via the Internet. Compared to a standard online program, the impact of enhanced online features, such as personalised feedback and strategies to enhance website use, will be evaluated for their impact on both initial weight loss and the maintenance of lost weight in the longer-term.

Trial website

Nil

Trial related presentations / publications

Publications 
1.	Williams RL, Wood LG, Collins CE, Callister R. Comparison of fruit and vegetable intakes during weight loss in males and females. EJCN 2015 Jul 29. doi: 10.1038/ejcn.2015.123.
2.	O'Brien KM, Hutchesson MJ, Jensen M, Morgan PJ, Callister R, Collins CE. Participants in an online weight loss program can improve diet quality during weight loss: a randomized controlled trial. Nutrition Journal. 2014; 13(1):82. Impact factor:2.597, 36/77 Nutrition & Dietetics. 
3.	Hutchesson M, Tan C, Morgan P, Callister R, Collins CE. Self-monitoring in a web-based weight loss program is enhanced by extra individualized feedback and reminders. Journal of Medical Internet Research
4.	Hutchesson MJ, Collins CE, Morgan PJ, Watson JF, Guest M, Callister R. Changes to dietary intake during a 12-week commercial web-based weight loss program: a randomized controlled trial. European Journal of Clinical Nutrition. 2014: 68, 64–70.
5.	Collins CE, Neve MJ, Williams R, Young M, Morgan PJ, Fletcher K, Callister R. Effectiveness of interventions with a dietary component on weight loss maintenance: A systematic review. JBI Database of Systematic Reviews and Implementation Reports. 2013; 11(8): 317-414.
6.	Collins CE, Morgan PJ, Hutchesson MJ, Callister R. Efficacy of Standard Versus Enhanced Features in a Web-Based Commercial Weight-Loss Program for Obese Adults, Part 2: Randomized Controlled Trial. Journal of Medical Internet Research, 2013. 15(7): e140.
7.	Collins CE, Morgan PJ, Jones P, Fletcher K, Martin J, Aguiar EJ, Lucas A, Neve MJ, Callister R. A 12-week commercial web-based weight-loss program for overweight and obese adults: randomized controlled trial comparing basic versus enhanced features. Journal of Medical Internet Research, 2012. 14(2): p. e57.
8.	Collins CE, Morgan PJ, Jones P, Fletcher K, Martin J, Aguiar EJ, Lucas A, Neve M, McElduff P, Callister R. Evaluation of a commercial web-based weight loss and weight loss maintenance program in overweight and obese adults: a randomized controlled trial. BMC Public Health, 2010. 10: 669.

Conference abstracts:
1.	Rebecca Williams, Lisa Wood, Clare Collins, Robin Callister. Comparison of fruit and vegetable intakes during weight loss in males and females. Abstract; Nutrition Society of Australia, Wellington, New Zealand, 2015.
2.	Robin Callister , Rebecca Williams , Lisa Wood , Philip Morgan , Clare Collins. Energy and appetite regulating hormones: Sex and weight category differences prior to weight loss. Abstract; ANZOS, Melbourne, 2013. 
3.	Rebecca Williams, Lisa Wood, Clare Collins, Robin Callister. Energy and appetite regulating hormones: Do they differ between males and females? Abstract; Nutrition Society of Australia, Brisbane, 2013.
4.	O’Brien K, Neve MJ, Morgan PJ, Callister R, Collins CE. Participants in a commercial online weight loss program can improve diet quality during weight loss: A randomized controlled trial. Obesity Facts, 6(s1), 159. European Congress of Obesity 2013.
5.	Collins CE, Morgan PJ, Neve M, Callister R. Efficacy of a web-based commercial weight loss program applying automated and personalised e-feedback. 2013 Annual Meeting of the International Society of Behavioural Nutrition and Physical Activity. Ghent, Belgium. 
6.	Collins CE, Neve MJ, Callister R, Morgan PJ. Changes in dietary intake 12-week commercial web-based weight loss program. 21st Annual Scientific Meeting, Australian and New Zealand Obesity Society, Adelaide, Australia. Obesity Research and Clinical Practice. 2011; 5(S1): 65. 
7.	Callister R, Morgan PJ, Collins CE. Sex differences in the time course of weightloss using a commercial online weight-loss. program. 22nd Annual Scientific Meeting, Australian and New Zealand Obesity Society, Auckland, New Zealand. Obesity Research & Clinical Practice 2012:6(S1):58
8.	Martin L, Collins CE, Neve M, Guest M, Callister R, Morgan P. Characteristics and dietary intakes of adult mis-reporters entering a weight loss study. International Conference on Diet and Activity Methods. 2012. Rome, Italy.  
9.	Collins CE, Morgan PJ, Neve MJ, McElduff P, Callister R. 6-month outcomes in a randomised controlled trial comparing basic and enhanced versions of a commercial web-based weight loss program. 21st Annual Scientific Meeting, Australian and New Zealand Obesity Society, Adelaide, Australia. Obesity Research and Clinical Practice. 2011; 5(S1):48. 
10.	Collins CE, Morgan PJ, McElduff P, Callister R. Efficacy of Commercial Web-Based Weight Loss: A Randomized Controlled Trial Comparing Programs with Basic versus Enhanced Features. Journal of the American Dietetic Association, 2011. 111(S9): A11
11.	Collins CE, Neve MJ, Callister R, Morgan PJ. Changes in dietary intake 12-week commercial web-based weight loss program. 21st Annual Scientific Meeting, Australian and New Zealand Obesity Society, Adelaide, Australia. Obesity Research and Clinical Practice. 2011; 5(S1): 65
12.	Callister R, Lucas A, Morgan PJ, Collins CE. Sex differences in weight loss and biomarker responses to an online weight loss program. 2011 Annual Meeting of the International Society for Behavioural Nutrition and Physical Activity. June 2011. Melbourne, Australia
13.	Fletcher K, Collins CE, Morgan PJ, Callister R. Effectiveness of interventions with a dietary component on weight loss maintenance: A systematic review. 2011 Annual Meeting of the International Society for Behavioural Nutrition and Physical Activity. June 2011. Melbourne, Australia
14.	Collins CE, Affiliations Faculty of Health, The University of Newcastle, Australia Morgan PJ, Fletcher K, Martin J, Jones P, Aguiar E, Lucas A, Callister R. A randomised controlled trial using a commercial web-based weight loss program. Obesity Research and Clinical Practice. 2010. 4 (S1):S72:273

Public notes

Contacts

Principal investigator

Name

Prof Clare Collins

Address

Priority Research Centre in Physical Activity and Nutrition
Rm 301 Advanced Technology Building
The University of Newcastle
University Drive, Callaghan
NSW 2308 Australia

Country

Australia

Phone

+61 2 49215646

Fax

clare.collins@newcastle.edu.au

Contact person for public queries

Name

Associate Professor Clare Collins

Address

Priority Research Centre in Physical Activity and Nutrition
Rm 301 Advanced Technology Building
The University of Newcastle
University Drive, Callaghan
NSW 2308 Australia

Country

Australia

Phone

+61 2 49215646

Fax

+61 2 49217053

clare.collins@newcastle.edu.au

Contact person for scientific queries

Name

Clare Collins

Address

Priority Research Centre in Physical Activity and Nutrition
Rm 301 Advanced Technology Building
The University of Newcastle
University Drive, Callaghan
NSW 2308 Australia

Country

Australia

Phone

+61 2 49215646

Fax

+61 2 49217053

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

Source	Title	Year of Publication	DOI
Embase	A 12-week commercial web-based weight-loss program for overweight and obese adults: randomized controlled trial comparing basic versus enhanced features.	2012	https://dx.doi.org/10.2196/jmir.1980
Embase	Efficacy of standard versus enhanced features in a Web-based commercial weight-loss program for obese adults, part 2: randomized controlled trial.	2013
Embase	Efficacy of standard versus enhanced features in a Web-based commercial weight-loss program for obese adults, part 2: randomized controlled trial.	2013	https://dx.doi.org/10.2196/jmir.2626
Embase	Enhancement of Self-Monitoring in a Web-Based Weight Loss Program by Extra Individualized Feedback and Reminders: Randomized Trial.	2016	https://dx.doi.org/10.2196/jmir.4100
Embase	Comparison of Australian recommended food score (ARFS) and plasma carotenoid concentrations: A validation study in adults.	2017	https://dx.doi.org/10.3390/nu9080888
Embase	The comparative validity of a brief diet screening tool for adults: The Fruit And Vegetable VAriety index (FAVVA).	2019	https://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.

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