Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000389101
Ethics application status
Approved
Date submitted
8/03/2019
Date registered
12/03/2019
Date last updated
11/11/2020
Date data sharing statement initially provided
12/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
TEXT message Behavioural Intervention for Teens on Eating, physical activity and Social Wellbeing (TEXTBITES)
Scientific title
Prevention of obesity in adolescents using text messages: a randomised controlled trial
Secondary ID [1] 297665 0
Nil known
Universal Trial Number (UTN)
U1111-1229-7560
Trial acronym
TEXTBITES
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Obesity 311942 0
Cardiovascular disease 311943 0
Condition category
Condition code
Diet and Nutrition 310525 310525 0 0
Obesity
Public Health 310549 310549 0 0
Health promotion/education
Cardiovascular 310550 310550 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TEXTBITES: 6-month intervention consisting of healthy lifestyle text messages and optional telephone health counselling delivered via mobile phone and usual care.

Healthy lifestyle text messages: Semi-personalised text messages will be sent on 4 random days/week (including 1 day/weekend) for 6-months (96 text messages in total) on each of four priority areas for adolescent health, namely, physical activity, nutrition, psychosocial wellbeing, and general behaviours. The text messages will encourage two-way communication and prompt participants to change their behaviours by providing practical tips and strategies. Text messages will be delivered using an existing purpose-built cloud-based delivery system. The system has well-developed systems for managing the text messages and monitoring participant data. This includes safety, privacy and security systems with analytic data and the ability to semi-personalise text message content and frequency.

Optional telephone health counselling: Intervention participants will also have opportunity to communicate by telephone with a health counsellor (university qualified allied health professional) up to 6 times over 6-months (once per month). The personalised health counselling calls will last 10-15 minutes and be delivered according to standardized protocol. The university qualified health counsellor will monitor and respond to participants’ request for a call each month either via text message or phone call within 3 working days. Health counselling calls will allow participants to set behavioural goals, discuss barriers and enablers to behaviour change, and their overall progress.
Intervention code [1] 313896 0
Behaviour
Intervention code [2] 313902 0
Prevention
Intervention code [3] 313903 0
Lifestyle
Comparator / control treatment
The control group will receive an introductory text message, a reminder to attend 6- and 12-month follow-ups and receive usual care. For the purpose of this study, usual care is defined as accessing currently available health services and information for adolescent obesity prevention.
Control group
Active

Outcomes
Primary outcome [1] 319382 0
Change in BMI z-score measured using calibrated stadiometer and electronic scales
Timepoint [1] 319382 0
At baseline, 6- and 12-months after intervention commencement
Secondary outcome [1] 367969 0
Change in waist-to-height (W:H) ratio measured using a non-stretch plastic waist measurement tape midway between the iliac crest and the lowest rib and a calibrated stadiometer
Timepoint [1] 367969 0
At baseline, 6- and 12-months after intervention commencement
Secondary outcome [2] 367970 0
Change in body composition (including total body weight (TBW), fat mass (FM) and fat-free mass (FFM)) will be calculated using specific equations in a random 20% sub-sample of participants (30/150) using data from the Tanita DC430MA Portable Body Composition Analyser
Timepoint [2] 367970 0
At baseline and 6-months after intervention commencement
Secondary outcome [3] 367971 0
Change in diet quality, food choices and food patterns measured using the Australian Child and Adolescent Eating Survey (ACAES)
Timepoint [3] 367971 0
At baseline and 6-months after intervention commencement
Secondary outcome [4] 367972 0
Change in adherence to dietary guidelines measured using short questions adapted from the NSW Population Health Survey
Timepoint [4] 367972 0
At baseline, 6- and 12-months after intervention commencement
Secondary outcome [5] 367973 0
Change in physical activity measured using validated short questions
Timepoint [5] 367973 0
At baseline, 6- and 12-months after intervention commencement
Secondary outcome [6] 367974 0
Change in physical activity measured objectively in a random 20% sub-sample of participants (30/150) using Actigraph GT3X+ activity monitors worn for 7 days
Timepoint [6] 367974 0
At baseline and 6-months after intervention commencement
Secondary outcome [7] 367975 0
Change in sedentary behaviours measured using the Adolescent Sedentary Activity Questionnaire (ASAQ)
Timepoint [7] 367975 0
At baseline, 6- and 12-months after intervention commencement
Secondary outcome [8] 367976 0
Change in sleep quality measured using Pittsburgh Sleep Quality Index Short (PSQI-Short)
Timepoint [8] 367976 0
At baseline, 6- and 12-months after intervention commencement
Secondary outcome [9] 367977 0
Change in quality of life measured using Paediatric Quality of Life Inventory (PedsQL) Version 4.0 Generic Core Scales questionnaire
Timepoint [9] 367977 0
At baseline, 6- and 12-months after intervention commencement
Secondary outcome [10] 367978 0
Change in self-esteem measured using Rosenberg Self-Esteem Scale
Timepoint [10] 367978 0
At baseline, 6- and 12-months after intervention commencement
Secondary outcome [11] 367979 0
Change in self-efficacy measured using a questionnaire adapted from the Project Eat Survey II
Timepoint [11] 367979 0
At baseline, 6- and 12-months after intervention commencement
Secondary outcome [12] 367980 0
Change in social support measured using a questionnaire adapted the social support and eating habits survey and the Social Support Scale for Physical Activity
Timepoint [12] 367980 0
At baseline, 6- and 12-months after intervention commencement
Secondary outcome [13] 367981 0
Eating disorders measured using the Eating Disorder Examination questionnaire (EDE-Q)
Timepoint [13] 367981 0
At baseline, 6- and 12-months after intervention commencement
Secondary outcome [14] 367982 0
Depression measured using the Centre for Epidemiological Studies Depression Scale Revised-10
Timepoint [14] 367982 0
At baseline, 6- and 12-months after intervention commencement

Eligibility
Key inclusion criteria
13 to 18 years inclusive;
Overweight (as defined by the International Obesity Task Force as equivalent to adult BMI 25.0-29.9 kg/m2);
Own an operational mobile phone, capable of sending and receiving text-messages;
Provide written informed consent.
Minimum age
13 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of Type 1 diabetes or Type 2 diabetes;
Medical condition or psychiatric illness that would not allow the participant to give informed consent and/or would preclude the participant’s ability to comply with the study protocol;
History of disordered eating including being diagnosed with, or treated for Anorexia, Nervosa or Anorexia Athletica, Binge Eating Disorder or Bulimia Nervosa;
Pregnancy, or planning to become pregnant within the next 12 months;
On weight loss medications or any medications known to cause weight gain;
Enrolled in an alternative randomised weight management program;
Already participating in a text message-based study;
Inability of the participant to 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)
The random allocation sequence will be concealed from study personnel and will take place after the baseline data collection. Study personnel conducting 6- and 12-month follow-up assessments will also be blinded to parallel group assignment. Participants and their parents will be encouraged to not discuss whether they are or are not receiving the TEXTBITES program during their follow up visit.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After the enrolment visit, participants will be randomly assigned to either usual care (control) or the text-message intervention group using a permuted block randomisation stratified by gender and recruitment site/strategy in a uniform 1:1 (control: intervention) allocation ratio. Randomisation will be conducted independently using a central computer-based randomisation service within REDCap.
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
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline demographic characteristics, attrition rates and average number of text messages sent, and received for participants will be tabulated and compared using descriptive statistics. Categorical variables will be summarised using totals numbers and percentages. Continuous variables will be summarised using mean and standard deviation for normally distributed data or median and inter-quartile range for data which is not normally distributed. We will compare the baseline characteristics of completers and non-completers to examine attrition bias using t tests for continuous variables and chi-square tests for categorical variables.

Actigraph GT3X+ accelerometer data will be captured in 1-15 second epochs to capture the intermittent activity patterns of adolescents and downloaded using the ActiLife software into an excel spreadsheet. To evaluate time spent in different intensity physical activities, we will classify by intensity level using count thresholds specific to adolescents. Previously published bioelectrical impedance analysis (BIA) equations specific the adolescent population will be used to estimate TBW, FFM and FM from raw data from the Tanita DC430MA Portable Body Composition Analyser.

The primary analysis will include all available participant data and will be performed at the end of the study after all data has been collected. The analyses of the primary and secondary outcomes will be conducted according to the intention-to-treat principle. Continuous outcomes will be analysed at 6- and 12-months using analysis of covariance (ANCOVA), adjusting for baseline measurement of the outcome, gender and recruitment site/strategy. Categorical outcomes will be analysed at 6- and 12-months using log-binomial regression adjusting for baseline measurement of the outcome, gender and recruitment site/strategy.

Planned sub group analyses will investigate interactions between treatment and subgroups, including categories of age, socioeconomic status, ethnicity, to explore trends for future studies. A significance level of 0.05 will be used. All analyses will be undertaken using SAS (version 9.2 SAS Institute Inc. Cary NC, USA).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2019
Actual
16/12/2019
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
150
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 13340 0
Westmead Hospital - Westmead
Recruitment hospital [2] 13341 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 25941 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 302194 0
University
Name [1] 302194 0
The University of Sydney
Country [1] 302194 0
Australia
Funding source category [2] 302195 0
Government body
Name [2] 302195 0
National Health and Medical Research Council
Country [2] 302195 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, NSW 2006
Country
Australia
Secondary sponsor category [1] 302038 0
None
Name [1] 302038 0
Address [1] 302038 0
Country [1] 302038 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302874 0
Sydney Children's Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 302874 0
Corner Hawkesbury Road and Hainsworth Street, Locked Bag 4001, Westmead NSW 2145, Sydney Australia
Ethics committee country [1] 302874 0
Australia
Date submitted for ethics approval [1] 302874 0
21/09/2018
Approval date [1] 302874 0
17/01/2019
Ethics approval number [1] 302874 0
HREC/18/SCHN/374

Summary
Brief summary
Obesity is one of the greatest health challenges facing today’s adolescents, who are now the largest global population segment (>25%). In Australia, over 30% of adolescents (13-18 years) are overweight or obese. Weight gain during adolescence is related to heart disease in later life. Implementing accessible obesity interventions could save our society $2.1B over the next 10 years. Hence, it is important we develop contemporary, low-cost, and engaging population-based obesity prevention solutions. Presently, Australian adolescents have limited access to age-appropriate obesity prevention services. There is a growing body of evidence indicating text messaging interventions are effective for secondary prevention of heart disease and our team has a successful program of related research. However, there is limited evidence for the role of text messages to engage adolescent populations in obesity prevention behaviours. In our preliminary work, through expert workshops and consumer testing, we have developed a bank of 300 evidence-based text messages that are acceptable and engaging for adolescents. In this randomised controlled trial, we aim to test the effectiveness of this healthy lifestyle text message program (TEXTBITES), with optional health counselling, compared to usual care in improving body mass index and lifestyle outcomes in overweight adolescents. Participants will be randomly assigned to the intervention program or standard care for 6-months. BMI and lifestyle outcomes will be assessed at the completion of the program, 6-months and all participants will be followed up 6-months later (12-months from baseline). There are no foreseen physical or psychological risks associated with participation in this study. For safety purposes, an independent, unblinded researcher will monitor all incoming text messages. This potentially scalable project will inform future practice and community initiatives to promote obesity prevention behaviours for adolescents.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91690 0
Dr Stephanie Partridge
Address 91690 0
Westmead Applied Research Centre, Department of General Practice, Acacia House, Westmead Hospital, Westmead, NSW, 2145
Country 91690 0
Australia
Phone 91690 0
+61 2 8890 8187
Fax 91690 0
Email 91690 0
[email protected]
Contact person for public queries
Name 91691 0
Dr Stephanie Partridge
Address 91691 0
Westmead Applied Research Centre, Department of General Practice, Acacia House, Westmead Hospital, Westmead, NSW, 2145
Country 91691 0
Australia
Phone 91691 0
+61 2 8890 8187
Fax 91691 0
Email 91691 0
[email protected]
Contact person for scientific queries
Name 91692 0
Dr Stephanie Partridge
Address 91692 0
Westmead Applied Research Centre, Department of General Practice, Acacia House, Westmead Hospital, Westmead, NSW, 2145
Country 91692 0
Australia
Phone 91692 0
+61 2 8890 8187
Fax 91692 0
Email 91692 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.