Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000949785
Ethics application status
Approved
Date submitted
30/06/2022
Date registered
5/07/2022
Date last updated
5/07/2022
Date data sharing statement initially provided
5/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Health4Me: text messaging to support adolescent physical and mental health and wellbeing in the community
Scientific title
Health4Me Randomised Controlled Trial (RCT): the efficacy of a 6-month text message program as primary prevention of cardiovascular disease among young people
Secondary ID [1] 306435 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease 325270 0
obesity 325271 0
type 2 diabetes 325272 0
poor mental health 325273 0
Condition category
Condition code
Public Health 322669 322669 0 0
Health promotion/education
Cardiovascular 322670 322670 0 0
Coronary heart disease
Diet and Nutrition 322671 322671 0 0
Obesity
Mental Health 322672 322672 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group
The intervention group (n=165) will receive a 6-month semi-personalised, two-way text message program and also have the opportunity to communicate by telephone or videoconference with an English-speaking university qualified health counsellor, trained in motivational interviewing over the 6-month intervention period. This study is completely virtual (online) and no in-person study visits are required.

The text messages are designed to support and improve physical and mental health over the intervention period. Based on our preliminary work, text messages were drafted based on four priority areas, namely, physical activity, nutrition and food industry, body image, mental health, media and climate change. These text messages will be contextualised and refined in Phase 1 of the study (not a RCT, no registration available), and therefore examples are not available at this time.

Message frequency and timing
Each intervention participant will receive a customised and semi-personalised set of text messages sent on 4 random days per week, including 1 day/weekend, and at random times. If the participant is attending high school, the weekday text messages will only be sent before or after school hours (8.00AM to 9.00AM or 3.30PM to 7.30 PM).

The text messages will be semi-personalised by selecting context relevant to the participants characteristics such as dietary behaviours, age and education or work setting. Each message will have a unique signature as the study name to ensure that participants know these messages are from the research study and participants at enrolment will be told how to unsubscribe if required. Participants can also update their key information, for example, mobile phone number, change in dietary behaviours through the course of the study and this will be reflected in the ongoing text messages they receive. Messages are sent at no cost to the participants and a bulk-rate cost to the study. The intervention will encourage two-way communication via questions/polls in the text messages asking participants to respond. All replies and responses will be reviewed in regular weekly team meetings. Adherence to the intervention will be monitored through the text message delivery software - where we are able to view number of text messages sent, delivered, bounced and undelivered. Adherence will also be monitored in the process evaluation at the end of the intervention period.

Role of the health counsellor
Once a month (6 in total), intervention participants will be sent a text message encouraging them to call the university qualified health counsellor to ask questions or request additional information. The personalised health counselling calls will last 10-15 minutes and will be delivered according to standardized protocol. The university qualified health counsellor (allied health or public health professional) will monitor and respond to participants’ request for a call each month either via text message or phone call within 3 working days. Participants are allowed 6 health counselling calls in total over 6-months. The health counselling calls will allow participants to set behavioural goals, discuss barriers and enablers to behaviour change, and their overall progress. This part of the intervention is based on the evidence-based TEXTBITES Study (ACTRN12619000389101) for obesity prevention in adolescents.
Intervention code [1] 322867 0
Prevention
Comparator / control treatment
The control group (n=165) will receive an introductory text message, a reminder to complete 2- and 4-month monitoring surveys and 6-month follow-up surveys and receive usual care.

For this study, usual care is defined as accessing health information and advice via usual methods (e.g. online, GP, family/friends, other health professionals)
Control group
Active

Outcomes
Primary outcome [1] 330466 0
Proportion of participants meeting moderate to vigorous physical activity (MVPA) minutes/day guidelines (as per the Australian 24-hour movement guidelines 5-17 years) as measured by accelerometry (Geneactiv activity and sleep unit)
Timepoint [1] 330466 0
6-months post intervention commencement
Primary outcome [2] 331891 0
Proportion of participants meeting vegetable intake guidelines (as per the Australian dietary guidelines), as a single item measure from the Australian Child and Adolescent Eating Survey (ACAES)
Timepoint [2] 331891 0
6-months post intervention commencement
Secondary outcome [1] 406325 0
Body Mass Index (BMI) z-score -using self-reported weight and height
Timepoint [1] 406325 0
6-months post intervention commencement
Secondary outcome [2] 406349 0
Waist to height ratio (WHR) - using self-reported waist circumference and height
Timepoint [2] 406349 0
6-months post intervention commencement
Secondary outcome [3] 406350 0
Dietary intake - measured with the Australian Child and Adolescent Eating Survey (ACAES)
Timepoint [3] 406350 0
6-months post intervention commencement
Secondary outcome [4] 406351 0
Sleep quality - as measured by the Pittsburgh Sleep Quality Index Short (PSQI-Short)
Timepoint [4] 406351 0
6-months post intervention commencement
Secondary outcome [5] 406352 0
Quality of life: - as measured by the Child Health Utility instrument (CHU9D)
Timepoint [5] 406352 0
6-months post intervention commencement
Secondary outcome [6] 406353 0
Self-efficacy - as measured by the Self-efficacy for Healthy Eating and Physical Activity (SE-HEPA)
Timepoint [6] 406353 0
6-months post intervention commencement
Secondary outcome [7] 406354 0
Anxiety - as measured by the General Anxiety Disorder-7 (GAD-7)
Timepoint [7] 406354 0
6-months post intervention commencement
Secondary outcome [8] 406355 0
Psychological Distress - as measured by the Kessler Psychological Distress Scale (K6)
Timepoint [8] 406355 0
6-months post intervention commencement
Secondary outcome [9] 406356 0
Depression - as measured with the Centre for Epidemiological Studies Depression Scale Revised-10 (CESDR-10)
Timepoint [9] 406356 0
6-months post intervention commencement
Secondary outcome [10] 406357 0
Eating disorder risk - as measured with the InsideOut Institute screening tool (IOI-S)
Timepoint [10] 406357 0
6-months post intervention commencement
Secondary outcome [11] 406358 0
Food insecurity - as measured with the USDA six-item food security module
Timepoint [11] 406358 0
6-months post intervention commencement
Secondary outcome [12] 406359 0
eHealth literacy - as measured with the eHealth Literacy Scale (eHEALS)
Timepoint [12] 406359 0
6-months post intervention commencement

Eligibility
Key inclusion criteria
(i) 12-18 years inclusive;
(ii) own a mobile phone, capable of sending and receiving text messages;
(iii) provide informed e-consent (or from parents or guardians if <14 years);
(iv) sufficient English to read text messages pitched at 7th grade reading level
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(i) diagnosis of type 1 or type 2 diabetes mellitus;
(ii) Previous or current diagnosis of an eating disorder OR at high risk for an eating disorder as assessed in screening;
(iii) Weight < 25th centile;
(iv) Recent rapid weight loss;
(ii) medical condition that would preclude informed consent or ability to comply with study protocol;
(iii) enrolled in an alternative randomised lifestyle management program;
(iv) pregnancy;
(v) Inability of the participant to read English at a 7th grade reading level

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)
Randomisation will be conducted independently using a central computer-based randomisation service within REDCap.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After e-consent and baseline measures, participants will be randomly assigned to either usual care (control) or the text-message intervention group using a permuted block randomisation stratified by age and work or education setting in a uniform 1:1 (control:intervention) allocation ratio.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
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
For the outcome of MVPA (minutes per day), 264 (132 per group) participants are needed to achieve 90% power to observe the mean difference of 14.8 (control: 42.55 and intervention: 57.36) with standard deviations (SD) of 21.45 for control and 37.79 for intervention and accounting for 30% dropout. To detect a difference in vegetable intake at 6-months, 330 (165 per group) participants will achieve 90% power to detect 13.37% difference in the proportion of appropriate vegetable consumption (control: 4.85% and intervention: 18.22%) and accounting for 30% dropout.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2022
Actual
Date of last participant enrolment
Anticipated
31/08/2023
Actual
Date of last data collection
Anticipated
29/02/2024
Actual
Sample size
Target
330
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310782 0
Government body
Name [1] 310782 0
Medical Research Future Fund, Department of Health
Country [1] 310782 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, NSW 2006 Australia.
Country
Australia
Secondary sponsor category [1] 312020 0
None
Name [1] 312020 0
Address [1] 312020 0
Country [1] 312020 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310356 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 310356 0
Ethics committee country [1] 310356 0
Australia
Date submitted for ethics approval [1] 310356 0
22/04/2022
Approval date [1] 310356 0
30/06/2022
Ethics approval number [1] 310356 0
2022/402

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

Contacts
Principal investigator
Name 117362 0
Dr Stephanie Partridge
Address 117362 0
Level 6, Block K
Westmead Hospital
Westmead NSW 2145
Country 117362 0
Australia
Phone 117362 0
+61288908187
Fax 117362 0
Email 117362 0
stephanie.partridge@sydney.edu.au
Contact person for public queries
Name 117363 0
Rebecca Raeside
Address 117363 0
Level 6, Block K
Westmead Hospital
Westmead NSW 2145
Country 117363 0
Australia
Phone 117363 0
+61412961432
Fax 117363 0
Email 117363 0
rebecca.raeside@sydney.edu.au
Contact person for scientific queries
Name 117364 0
Rebecca Raeside
Address 117364 0
Level 6, Block K
Westmead Hospital
Westmead NSW 2145
Country 117364 0
Australia
Phone 117364 0
+61412961432
Fax 117364 0
Email 117364 0
rebecca.raeside@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As per approved protocol. Results will stay within the research team and only the research team will have access to deidentified participant data.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
5130ProtocolYeshttps://doi.org/10.1186/s12889-024-17698-5 Corrected sample size.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA healthy lifestyle text message intervention for adolescents: protocol for the Health4Me randomized controlled trial.2022https://dx.doi.org/10.1186/s12889-022-14183-9
N.B. These documents automatically identified may not have been verified by the study sponsor.