Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000949785
Ethics application status
Approved
Date submitted
22/08/2013
Date registered
27/08/2013
Date last updated
1/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Get Healthy- Stay Healthy: a text message-delivered intervention on physical activity, dietary behaviours and weight loss
Scientific title
'Get Healthy, Stay Healthy': the effect of a text message-delivered lifestyle intervention delivered to community-based adults following the Get Healthy Information and Coaching Service (Registered Trademark) on physical activity, dietary behaviours and weight loss
Secondary ID [1] 283063 0
Nil known
Universal Trial Number (UTN)
Trial acronym
GHSH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical activity 289900 0
dietary behaviours 289901 0
weight loss 289902 0
Condition category
Condition code
Public Health 290265 290265 0 0
Health promotion/education
Public Health 290267 290267 0 0
Health service research
Diet and Nutrition 290291 290291 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Get Healthy-Stay Healthy (GHSH) intervention is specifically designed to follow-on from the Get Healthy Coaching Service (GHS). The 6-month GHSH extended-contact intervention is primarily delivered via text messages that are individually-tailored in terms of frequency, timing, content and wording. In order to tailor the text message content and to negotiate the participant’s text messaging preferences, participants receive two tailoring telephone calls, e.g. 20-30 minutes; one call at the start of the intervention; and another call at mid-intervention. During the GHSH extended contact intervention participants choose whether they focus on a weight loss (no more than 2kg per month) or weight maintenance goal and whether they focus on physical activity or diet or both behaviours (with targets consistent with national guidelines for physical activity and healthy eating).
Intervention code [1] 287782 0
Lifestyle
Intervention code [2] 287800 0
Behaviour
Comparator / control treatment
The control group receives no contact, except for the evaluations at baseline, 6- and 12-months. Following completion of each assessment, control group participants are posted brief written feedback on their data. This feedback is to reduce attrition in the control group in the study.
Control group
Active

Outcomes
Primary outcome [1] 290292 0
Moderate-vigorous intensity physical activity as assessed by accelerometer (Actigraph GT1M) and 3-item physical activity assessment tool
Timepoint [1] 290292 0
Baseline, 6 months (end of extended contact intervention)and 12 months (end of no contact maintenance period) after randomisation
Primary outcome [2] 290293 0
Dietary Behaviours as assessed by the Fat & Fibre Behaviour Questionnaire and questions on number of servings of fruit and vegetables per day (continuous); frequency of consumption of sweetened drinks per day; and takeaway meals per week (categorical)
Timepoint [2] 290293 0
Baseline, 6 months (end of extended contact intervention)and 12 months (end of no contact maintenance period) after randomisation
Primary outcome [3] 290294 0
Body weight (kg) and waist circumference (cm) as reported by the participants
Timepoint [3] 290294 0
Baseline, 6 months (end of extended contact intervention)and 12 months (end of no contact maintenance period) after randomisation
Secondary outcome [1] 304265 0
Feasibility indicators as assessed by number and type of text message sent, number and duration of tailoring interviews completed and number of prompted and unprompted text message replies from participants
Timepoint [1] 304265 0
Data collected during intervention delivery
Secondary outcome [2] 304266 0
Acceptability indicators as assessed by: recall of number of texts received, treatment of texts on receipt, categorical satisfaction ratings and qualitative feedback on intervention
Timepoint [2] 304266 0
At 6 month assessment
Secondary outcome [3] 304267 0
Mediators of physical activity and dietary behaviour change targeted in GHSH: outcome expectancy, satisfaction with perceived outcomes, self-regulation, self efficacy, social support and perceived environmental opportunity questions
Timepoint [3] 304267 0
Data collected at baseline, 6 months and 12 months via paper-based self-reported questionnaire designed specifically for this study.
Secondary outcome [4] 304270 0
Moderators of physical activity and dietary behaviour change based on: demographics (e.g. age, education), health status (e.g. chronic diseases, need for medical clearance before commencing the telephone coaching service), and behavioural and anthropometric changes during initial telephone coaching service
Timepoint [4] 304270 0
Data collected during previous evaluation of the initial GHS. Data collected via telephone interview using standard questions.

Eligibility
Key inclusion criteria
Living in New South Wales, Australia; completed the Get Healthy Coaching Service (GHS); no intention of re-enrolling in GHS; not involved in the GHS cohort evaluation (O'Hara, B.J., et al., Effectiveness of Australia's Get Healthy Information and Coaching Service: maintenance of self-reported anthropometric and behavioural changes after program completion. BMC public health, 2013. 13: p. 175.); and ownership of a mobile telephone
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Re-enrolling to the GHS; involved in the GHS cohort evaluation; does not own a mobile telephone

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)
Participants for this study were recruited on a rolling basis from the pool of participants who completed the GHS between August 2012 and February 2013. During the recruitment timeframe, all GHS completers were invited to register their interest for the GHSH study by their GHS coach during the final coaching call. Verbal consent to contact was recorded and then GHS coaches emailed client contact details to the researchers. Interested participants were mailed a Participant Information Sheet and Consent Form and then contacted via telephone to establish their eligibility and willingness to consent to participate in the GHSH trial. Verbal consent to participation was audio recorded, and participants returned the signed Consent Form via reply paid post.
Once informed verbal consent was obtained, the participants underwent the GHSH baseline assessment and were then randomised to one of the study groups. Participants were stratified based on their change in weight during the Get Healthy Service (using the median weight loss of 3kg). Randomisation was conducted using a randomisation website (www.randomization.com), and allocation was conducted by a trained research assistant with no involvement in participant recruitment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were stratified based on their change in weight during the Get Healthy Service (using the median weight loss of 3kg). Randomisation was conducted using a randomisation website (www.randomization.com).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size estimates are driven by the between-group differences expected for physical activity, as this required the largest sample. Assuming an attrition rate of 20%, the targeted sample size is 103 participants per group (206 in total). This sample size will provide a minimum adequate power (80%) to detect a between groups change between baseline and 6 months of 30 minutes/week of objectively-measured moderate-vigorous physical activity (assuming a standard deviation of 70mins/wk).


Data will be analysed using intention-to-treat principles. Once a participant is randomised into a study group, they will be considered a trial participant and analysed according to their allocated group, regardless of missing data for follow-ups or the amount of intervention received. Patterns of missing data will be examined to determine the type of missing data (i.e. MCAR, MAR, NMAR) at each assessment point and will be treated accordingly (i.e. completers analysis, multiple imputation). Change in each primary outcome will be modelled using mixed linear models with random intercepts, the fixed effects of study group, time and a group by time interaction as well as baseline values (to account for regression to the mean). Potential confounders include baseline characteristics, change in behaviours and weight during the initial GHS, and the factors used to balance groups by minimisation. Confounders will be identified by forwards and backwards selection. Inclusion in the final model will require the addition or omission of the potential confounder to elicit a substantial change in the coefficient for the effect of intervention. A 20% change in coefficient will be considered substantial unless the coefficient is close to zero. Data analysis will be performed using the software SAS system for Windows (Version 9.3). Statistical significance will be set at the conventional two-tailed 5% level.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/07/2012
Actual
30/07/2012
Date of last participant enrolment
Anticipated
28/02/2013
Actual
28/02/2013
Date of last data collection
Anticipated
Actual
30/03/2014
Sample size
Target
206
Accrual to date
Final
228
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287827 0
Government body
Name [1] 287827 0
New South Wales Ministry of Health
Country [1] 287827 0
Australia
Funding source category [2] 287828 0
University
Name [2] 287828 0
The University of Queensland
Country [2] 287828 0
Australia
Primary sponsor type
University
Name
The University of Queensland, School of Population Health, Cancer Prevention Research Centre
Address
Cancer Prevention Research Centre, School of Population Health, Public Health Building, University of Queensland, Herston Rd, Herston Qld 4006
Country
Australia
Secondary sponsor category [1] 286555 0
University
Name [1] 286555 0
University of Sydney, Prevention Research Collaboration
Address [1] 286555 0
Prevention Research Collaboration
Level 2, Medical Foundation Building K25
University of Sydney NSW 2006
Country [1] 286555 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289772 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 289772 0
Level 6, Jane Foss Russell Building
University of Sydney NSW 2006
Ethics committee country [1] 289772 0
Australia
Date submitted for ethics approval [1] 289772 0
31/01/2011
Approval date [1] 289772 0
18/05/2012
Ethics approval number [1] 289772 0
13523

Summary
Brief summary
The aim of this study is to evaluate, in a randomised controlled trial, the feasibility, acceptability and efficacy of a text message-delivered intervention to enhance physical activity, dietary change and weight loss among adults who have completed the 6-month Get Healthy Coaching Service. It is expected that this extended contact via text messaging will lead to sustained behaviour change and weight loss compared to no on-going contact.
Trial website
Trial related presentations / publications
Fjeldsoe BS, Goode AD, Phongsavan P, Bauman A, Maher G, Winkler E, Eakin EG. Evaluating the maintenance of lifestyle changes in a randomized controlled trial of the ‘Get Healthy, Stay Healthy’ program. JMIR Mhealth Uhealth. 2016 May 10;4(2):e42. doi: 10.2196/mhealth.5280. PMID: 27166643
Fjeldsoe, B. Phongsavan, P. Bauman, A. Goode, A. Maher, G. Eakin, E. (2014). `Get Healthy, Stay Healthy’: protocol for evaluation of a lifestyle intervention delivered by text-message following the Get Healthy Information and Coaching Service®. BMC Public Health, 14:112.
Public notes

Contacts
Principal investigator
Name 42342 0
Dr Brianna Fjeldsoe
Address 42342 0
Cancer Prevention Research Centre, School of Population Health, Public Health Building, University of Queensland, Herston Rd, Herston Qld 4006
Country 42342 0
Australia
Phone 42342 0
+61733655544
Fax 42342 0
Email 42342 0
[email protected]
Contact person for public queries
Name 42343 0
Brianna Fjeldsoe
Address 42343 0
Cancer Prevention Research Centre, School of Population Health, Public Health Building, University of Queensland, Herston Rd, Herston Qld 4006
Country 42343 0
Australia
Phone 42343 0
+61 7 3365 5598
Fax 42343 0
Email 42343 0
[email protected]
Contact person for scientific queries
Name 42344 0
Brianna Fjeldsoe
Address 42344 0
Cancer Prevention Research Centre, School of Population Health, Public Health Building, University of Queensland, Herston Rd, Herston Qld 4006
Country 42344 0
Australia
Phone 42344 0
+61 7 3365 5598
Fax 42344 0
Email 42344 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
EmbaseDose and engagement during an extended contact physical activity and dietary behavior change intervention delivered via tailored text messaging: exploring relationships with behavioral outcomes.2021https://dx.doi.org/10.1186/s12966-021-01179-8
N.B. These documents automatically identified may not have been verified by the study sponsor.