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Trial registered on ANZCTR


Trial ID
ACTRN12612000924853
Ethics application status
Approved
Date submitted
27/08/2012
Date registered
30/08/2012
Date last updated
19/03/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
‘TXT2BFiT’ a mobile phone-based healthy lifestyle program for preventing unhealthy weight gain in young adults: study protocol for a randomized controlled trial
Scientific title
Effect of a nine-month mobile phone-based healthy lifestyle program 'TXT2BFiT' on weight management and prevention of weight gain among young adults aged 18 to 35 years.
Secondary ID [1] 280990 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of weight gain 287120 0
Condition category
Condition code
Public Health 287441 287441 0 0
Health promotion/education
Diet and nutrition 287621 287621 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention participants receive:
1. A mailed eighteen-page booklet ("Guide to Healthy Eating and Activity to Achieve and Maintain a Healthy Weight") containing the two-page control handout, as well as sample meal plans, recommendations for daily servings from the core food groups with example serving sizes, and information about the four target behaviours addressed by the program: physical activity and sedentary behaviour, as well as intake of fruit and vegetables, energy-dense take-away meals, and sugar-sweetened drinks.
2. Handouts (print and electronic format) ‘Easy, Healthy Eating on a Budget’, ‘Emergency Meal Tool Kit’, ‘Meal Planning Worksheet’, ‘COMMIT YOURSELF: Physical Activity Planner’, ‘Seasonal Guide to Vegetables and Fruits’, ‘Tips for Take-Away’ and ‘Staying Healthy over the Holidays’;
2. Smartphone applications (one each for physical activity, intake of fruit and vegetables, takeaways, and sugar sweetened drinks);
3. Online weight tracking application;
4. Online community forum;
5. SMS text messages: 8/week for first 12 weeks, followed by 1/month (tailored to the processes-of-change outlined in the Transtheoretical model for health behaviour change);
6. Email messages: 1/week for first 12 weeks, followed by 1/month (provide reminders to access materials available from the website);
7. Phone coaching calls: weeks 0, 2, 5, 8, and 11, followed by booster coaching calls at 5 and 8 months (coaching calls are based on motivational counselling principles).

Through these various materials participants in the intervention are consistently encouraged to (1) consume five servings of vegetables and two servings of fruit per day, in line with the national dietary recommendations; (2) limit energy-dense take-away meals to once per week or less; (3) limit sugar-sweetened drinks to less than one litre per week; (4) perform 60 minutes or more of moderate-intensity physical activity most days of the week (preferably daily).

Total duration of the intervention is 9 months (36 weeks). A website acts as the platform for delivering electronic handouts, downloading Smartphone applications, and using the weight tracking application and community blog.
Intervention code [1] 285438 0
Prevention
Intervention code [2] 285439 0
Lifestyle
Intervention code [3] 285440 0
Behaviour
Comparator / control treatment
Control participants receive:
1. A mailed two-page handout summarising the Australian national dietary and physical activity guidelines,
2. An introductory call (week 0) to introduce the program (no coaching),
3. Four SMS text messages (one every three weeks during weeks 1 to 12) that re-iterate information in the handout, and
4. Limited access to the TXT2BFiT website, (electronic versions of the two-page handout, consent form and study information statement, general information about the study and contact information).

Total duration of the control treatment is 3 months (12 weeks), with follow-up after 12-weeks and 9 months.
Control group
Active

Outcomes
Primary outcome [1] 287707 0
Body weight is measured to the nearest 0.1 kg at baseline by their general practitioner and again in week 13 by study personnel.
Self-reported weight is collected in weeks 0, 13 and 40 via an online survey.
Timepoint [1] 287707 0
Baseline (Week 0), after first 12 weeks (Week 13), and after the following 6 months (Week 40).
Secondary outcome [1] 298662 0
Fruit and vegetable intake:
Self-report according to short dietary questions;
Indirect self-report from total energy and dietary fibre of the diet according to Food Frequency Questionnaire.
Timepoint [1] 298662 0
Baseline (Week 0), after first 12 weeks (Week 13), and after the following 6 months (Week 40; short questions only).
Secondary outcome [2] 298663 0
Physical activity:
Self report according to International Physical Activity Questionnaire;
Indirect self-report from total sitting time according to domain specific sitting time questionnaire.
Timepoint [2] 298663 0
Baseline (Week 0), after first 12 weeks (Week 13), and after the following 6 months (Week 40).
Secondary outcome [3] 298664 0
Energy-dense takeaway (fast-food) meals: Self-report according to short dietary question; Indirect self-report from total energy, fat and saturated fat of the diet according to Food Frequency Questionnaire.
Timepoint [3] 298664 0
Baseline (Week 0), after first 12 weeks (Week 13), and after the following 6 months (Week 40; short question only).
Secondary outcome [4] 298665 0
Sugar sweetened drinks intake: Self-report according to short dietary question; Indirect self-report from total energy and sugar of the diet according to Food Frequency Questionnaire.
Timepoint [4] 298665 0
Baseline (Week 0), after first 12 weeks (Week 13), and after the following 6 months (Week 40; short question only).

Eligibility
Key inclusion criteria
Aged 18 to 35 years.
Body mass index 25.0 to 31.9 kg/m2 or 23.0 to 24.9 kg/m2 with reported weight gain > 2 kg over past 12 months.
Fruit intake < two serves/day and/or vegetable intake < five serves/day and/or sugar sweetened beverage intake >= 1 L/week and/or energy-dense take-away meals > once/week and/or moderate intensity physical activity < 60 minutes/day.
Has mobile phone capable of receiving text messages and access to the Internet at least once a week.
Minimum age
18 Years
Maximum age
35 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnant or planning to fall pregnant within the next nine months.
Enrolled in an alternate weight loss program.
Has lost > 10 kg voluntarily in the past three months.
Taking medications that have caused > 2 kg weight gain.
Medical condition that precludes following dietary or physical recommendations.
History of disordered eating.
Does not speak English.

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)
Australian primary health care services were re-organized in July 2011 into independent entities called ‘Medicare Locals’, which are responsible for coordinating primary health care over a specified geographic area. From the Medicare Local, fax and Email invitations are sent to general practitioners (GPs) within the area to partner in the recruitment of patients into the study. GPs returning their expression of interest are then contacted to arrange a time and date for the researchers to attend their practice clinic and to conduct an audit of their electronic patient database in order to identify suitable participants, that is, patients aged 18 to 35 years who have been seen by the GP in the prior 12 months. These patients are mailed a letter from the GP inviting them to participate in the research, along with a consent form and further information about the study. A maximum of 500 letters are sent from each general practice clinic. If more than 500 patients are identified, the first 500 patients are randomly selected. The invitation letter directs prospective participants to an online survey to screen for eligibility criteria. Questions in the screening survey are structured such that ineligible patients are redirected to a national social marketing website for healthy eating and physical activity promotion. Eligible patients reaching the end of the survey are able to nominate dates and times to attend an appointment with their GP at no cost to the patient. This 10 minute appointment is then booked for the patient and details of the appointment sent to the patient in a confirmatory short message service (SMS) text message.

At each appointment, the GP measures the patient’s weight and height and obtains the patient’s informed consent to participate in the trial by collecting their signed consent form. Signed consent forms are then faxed back to the researchers with the patient’s anthropometric data to confirm eligibility on the basis of their BMI and to enroll the patient in the trial. Enrolled patients are then randomized to the intervention or control arm by one of the researchers and allocated their treatment by another researcher by way of an introductory phone call (control participants) or a coaching call (intervention participants) provided in week 0.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible patients are randomized in a 1:1 ratio into intervention and control arms. Randomization is based on a stratified randomized block design, where the strata are the Medicare Local, general practice clinic, and participant gender. The random sequence will be generated by an independent researcher and concealed from those responsible for enrolling and assigning interventions to patients.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The primary outcome, body weight at three months, will be compared between the two groups using analysis of covariance adjusting for baseline weight and the stratification variables Medicare Local, general practice clinic and participant gender. The analysis will be by ‘intention-to-treat’ principle using multiple imputation to account for missing data. Secondary outcomes that are continuous will also be analyzed using analysis of covariance, while Chi-squared tests will be used to analyze dichotomous outcomes. Mixed models will be used to describe changes in outcomes over time. Personnel analyzing participant outcomes will be blinded to participant allocation. Further sensitivity analyses will be conducted using measures of participant engagement with program materials.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 285801 0
Commercial sector/Industry
Name [1] 285801 0
HCF Health and Medical Research Foundation
Address [1] 285801 0
GPO Box 4242
Sydney, NSW, 2001
Country [1] 285801 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
NSW, 2006
Country
Australia
Secondary sponsor category [1] 284625 0
University
Name [1] 284625 0
The University of New South Wales
Address [1] 284625 0
Sydney, NSW, 2052
Country [1] 284625 0
Australia
Secondary sponsor category [2] 284626 0
University
Name [2] 284626 0
The University of Technology, Sydney
Address [2] 284626 0
Broadway, NSW, 2007
Country [2] 284626 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287818 0
The University of Sydney, Human Research Ethics Committee
Ethics committee address [1] 287818 0
Research Integrity
Level 6, Jane Foss Russell Building G02,
University of Sydney, NSW, 2006
Ethics committee country [1] 287818 0
Australia
Date submitted for ethics approval [1] 287818 0
20/08/2012
Approval date [1] 287818 0
Ethics approval number [1] 287818 0

Summary
Brief summary
Despite concerted efforts at local, state and national levels to arrest increasing rates of obesity, young adults have largely been neglected. Our published research has shown young adults are more likely to face an obese future than their parents - potentially leading to an increased risk of chronic illness for the individual and increased health care costs to the nation. An important opportunity to prevent further increases in obesity prevalence is to reduce weight gain in young adults. We have identified four key behaviours to improve diet quality and promote energy balance in young adults: reduce consumption of energy-dense take-away foods; increase fruit and vegetables; increase physical activity and decrease sedentary time; and reduce sugar sweetened drinks. We know that young adults are difficult to reach with health messages which is partly due the lack of a clear setting for intervention with this group. Our focus group research and others have found that young adults prefer electronic dissemination including SMS messages, email, smartphone applications, websites and chat forums. Mobile phones are the most common medium for young adults to use to communicate with friends and family. Published studies assessing SMS for changing health behaviors have indicated their success in the short term for smoking cessation, increasing physical activity and weight loss. The primary aim of this study is to compare changes in weight and discrete nutrition, physical activity and sedentary behaviours in a population of young adults after receiving a nine-month mobile phone delivered intervention with changes in a control group. We hypothesize that our tailored intervention, including educational and motivational messages to improve lifestyle and attain/maintain a healthy weight, delivered using SMS, email, smartphone applications and a custom-designed website, will be more effective in improving young adults’ diets and physical activity, to manage their weight over nine months when compared with controls.
Trial website
http://txt2bfit.com/
Trial related presentations / publications
1. Allman-Farinelli MA, Chey T, Bauman AE, Gill T, James WPT. Age, period and birth cohort effects on prevalence of overweight and obesity in Australian adults from 1990 to 2000. Eur J Clin Nutr 2008;62(7):898-907. .
2. Allman-Farinelli MA, Chey T, Merom D, Bowles H, Bauman AE. The effects of age, birth cohort and survey period on leisure-time physical activity by Australian adults: 1990–2005. British Journal of Nutrition 2009;101(04):609-17.
3. Hebden L, Chey T, Allman-Farinelli M. Lifestyle intervention for preventing weight gain in young adults: a systematic review and meta-analysis of RCTs. Obesity Reviews 2012;13(8):692–710.
4. Hebden L, Cook A, van der Ploeg PH, Allman-Farinelli M. Development of smartphone applications for nutrition and physical activity behavior change. JMIR Res Protoc. 2012;1(2):e9.


Presentations May 2011 International Society of Behavioural Nutrition and Physical Activity: "Web and mobile intervention for weight gain prevention among young adults: a randomized controlled pilot study". Austin, Texas, US.
Public notes

Contacts
Principal investigator
Name 34550 0
A/Prof Margaret Allman-Farinelli
Address 34550 0
Room 479, Level 4, Molecular Bioscience Building (G08), School of Molecular Bioscience, The University of Sydney, NSW, 2006
Country 34550 0
Australia
Phone 34550 0
+61 2 9036 7045
Fax 34550 0
Email 34550 0
margaret.allman-farinelli@sydney.edu.au
Contact person for public queries
Name 17797 0
Ms Kate Balestracci
Address 17797 0
Room 447, Level 4, Molecular Bioscience Building (G08),
School of Molecular Bioscience,
The University of Sydney,
NSW, 2006
Country 17797 0
Australia
Phone 17797 0
+61 2 9351 3815
Fax 17797 0
+61 2 9351 5858
Email 17797 0
kate.balestracci@sydney.edu.au
Contact person for scientific queries
Name 8725 0
A/Prof Margaret Allman-Farinelli
Address 8725 0
Room 479, Level 4, Molecular Bioscience Building (G08),
School of Molecular Bioscience,
The University of Sydney,
NSW, 2006
Country 8725 0
Australia
Phone 8725 0
+61 2 9036 7045
Fax 8725 0
+61 2 9351 5858
Email 8725 0
margaret.allman-farinelli@sydney.edu.au