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Trial registered on ANZCTR


Registration number
ACTRN12618000723280
Ethics application status
Approved
Date submitted
29/04/2018
Date registered
2/05/2018
Date last updated
2/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Online and telephone support for multiple health risk behaviours among Technical and Further Education (TAFE) students
Scientific title
A cluster randomised trial of electronic feedback, online and telephone support on multiple health risk behaviours among Technical and Further Education (TAFE) students
Secondary ID [1] 294742 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a follow-up study that builds on the initial work completed as part of study ACTRN12615000105549.

Health condition
Health condition(s) or problem(s) studied:
Smoking 307626 0
Risky alcohol consumption 307627 0
Inadequate fruit and vegetable intake 307628 0
Physical inactivity 307629 0
Anxiety 307630 0
Depression 307631 0
Condition category
Condition code
Public Health 306694 306694 0 0
Health promotion/education
Diet and Nutrition 306695 306695 0 0
Obesity
Mental Health 306696 306696 0 0
Anxiety
Mental Health 306699 306699 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants who do not meet recommended Australian health guidelines for smoking, nutrition, alcohol or physical activity behaviours will be provided with feedback outlining the Australian recommendations and strategies that can assist the participant improve these behaviours. Based on participant responses during the baseline survey, brief, one-off feedback for the relevant health risk will appear on the iPad screen during the baseline survey for the participant to read.

For each of the health risk behaviours that participants do not meet recommended guidelines they will also be offered the following online and telephone interventions:

Online interventions:
QuitCoach program (smoking): The QuitCoach is an online program that provides individual, tailored advice and support to assist smokers to quit smoking. The QuitCoach takes about 15-20 minutes to complete and creates a personalised quitting plan by asking users to answer a series of questions about their smoking, plans to quit, motivation, confidence and past quit attempts. The QuitCoach is designed to be used multiple times and for the user to return to the online program to review their current situation.

Healthy Eating Quiz program (nutrition): The Healthy Eating Quiz is an online program that takes about 10-15 minutes to complete and examines the user’s intake of a variety of foods including vegetables, fruits, protein foods, grains, dairy, water, sauces and condiments. The Healthy Eating Quiz can be completed several times with the program providing the user with the option to have a reminder e-mail sent to them in one month to complete the quiz again.

THRIVE program (alcohol): THRIVE is an online program that involves a 5-10 minute session of motivational assessment and personalised feedback about the participant’s drinking behaviour, strategies for reducing alcohol consumption, and information on available support services. The THRIVE program examines the participant’s alcohol intake in the last 12 months, past drinking, drinking in the last 4 weeks, blood alcohol concentration and other students’ drinking. THRIVE can be used multiple times and allows the user to assess their current situation.

10,000 Steps program (physical activity): The 10,000 Steps online program takes about 10-15 minutes to complete and encourages participants to use a pedometer to record their daily step counts on their personal step log, indicate their goal steps and monitor their progress towards increasing physical activity. The 10,000 Steps program is designed to be used multiple times to monitor daily step counts and physical activity levels.

Telephone interventions:
NSW Quitline (smoking): The NSW Quitline offers multiple telephone counselling calls to smokers to encourage and support them to quit. The NSW Quitline will offer six proactive telephone counselling calls over a one month period to smokers who set a quit date. These calls will last about 5-10 minutes and be scheduled on the initial call, on the quit date, and at 3, 7, 14, and 30 days after the quit date.

Get Healthy Information and Coaching Service (nutrition and physical activity): The Get Healthy Information and Coaching Service offers a coaching program that includes 10 coaching telephone calls with a health coach over six months. During the first call the health coach will spend up to 20 minutes talking to the participant about nutrition and physical activity. During the first three months the health coach will make up to six telephone coaching calls which will last about 10-15 minutes. The health coach will provide the participant with up to four 10-15 minute telephone coaching calls during the last three months to offer support.

Alcohol Drug Information Service (alcohol):The NSW ADIS is a telephone service that provides callers information about their alcohol use and associated risks, advice about effective interventions for reducing or stopping alcohol use, and counselling tailored to the caller’s needs. During the 10-15 minute telephone call, the ADIS counsellors will provide personalised advice about the short-term and long-term effects of alcohol, effective interventions for reducing alcohol consumption and strategies for dealing with situations that trigger excessive alcohol use. The participant can call ADIS multiple times.

Intervention adherence: As part of the 6-month follow-up survey the number of intervention group participants who self-report using each of the online programs and/or telephone services in the past 6 months and exposure to these interventions will be determined.
Intervention code [1] 301042 0
Prevention
Intervention code [2] 301043 0
Lifestyle
Intervention code [3] 301044 0
Behaviour
Comparator / control treatment
Participants in the control condition will not receive any intervention. Control group participants will not be provided with any feedback regarding the health risk behaviours for which they do not meet Australian guidelines and will not be offered online or telephone support for these health risk behaviours.
Control group
Active

Outcomes
Primary outcome [1] 305698 0
Tobacco smoking. Assessed via participant self-report using two standard items: “Do you currently smoke any tobacco products?” and “Would you have smoked at least 100 cigarettes or the equivalent amount of tobacco in your life?”
Timepoint [1] 305698 0
6-months post-baseline
Primary outcome [2] 305699 0
Weekly alcohol consumption. Assessed via participant self-report using a 7-day retrospective diary, which asks participants how many standard drinks they consumed on each of the previous 7 days beginning with the previous day.
Timepoint [2] 305699 0
6-months post-baseline
Primary outcome [3] 305700 0
Weekly physical activity. Assessed via participant self-report using the Godin Leisure Time Exercise Questionnaire.
Timepoint [3] 305700 0
6-months post-baseline
Secondary outcome [1] 346193 0
Daily fruit intake (please note this is a primary outcome). Assessed via participant self-report using the National Health Survey item “How many serves of fruit do you usually eat each day? One serve of fruit is 1 medium sized piece of fruit (e.g. apple), 2 small pieces (e.g. apricots), 1 cup chopped or canned fruit”.
Timepoint [1] 346193 0
6-months post-baseline
Secondary outcome [2] 346194 0
Daily vegetable intake (please note this is a primary outcome). Assessed via participant self-report using the National Health Survey item “How many serves of vegetables do you usually eat each day? One serve of vegetables is half a cup of cooked vegetables, one medium potato or 1 cup salad vegetables.”
Timepoint [2] 346194 0
6-months post-baseline
Secondary outcome [3] 346195 0
Knowledge of recommended Australian guidelines (for smoking, nutrition, alcohol, physical activity). Assessed via participant self-report using investigator developed items that include a range of options from which the participant identifies the response that reflects the Australian guideline for the relevant health risk.
Timepoint [3] 346195 0
6-months post-baseline
Secondary outcome [4] 346196 0
Intentions to change health risk behaviours (for smoking, nutrition, alcohol, physical activity). Assessed via participant self-report using items that ask if the participant intends to improve the health risk behaviour with response options of in the next 30 days, in the next 6 months, may in the future but not in the next 6 months and never.
Timepoint [4] 346196 0
6-months post-baseline
Secondary outcome [5] 346197 0
Depression: The depression items (2 items) in the Patient Health Questionnaire-4 (PHQ-4) will assess participant’s symptoms of depression over the last 2 weeks. The response options are: not at all; several days; more than half the days; nearly every day.
Timepoint [5] 346197 0
6-months post-baseline
Secondary outcome [6] 346218 0
Anxiety: The anxiety items (2 items) in the Patient Health Questionnaire-4 (PHQ-4) will assess participant’s symptoms of anxiety over the last 2 weeks. The response options are: not at all; several days; more than half the days; nearly every day.
Timepoint [6] 346218 0
6-months post-baseline

Eligibility
Key inclusion criteria
Eligible students will: be currently enrolled in a class that runs for at least 12 months; aged 16 years or older; not meet Australian health guidelines for at least one of the following health risk behaviours: smoking, alcohol use, fruit intake, vegetable intake, or physical activity; and not attend any other TAFE campus.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include: 1) enrolled in a TAFE class that runs for less than 12 months; 2) aged less than 16 years; 3) meeting Australian guidelines for all the smoking, nutrition, alcohol and physical activity health behaviours; 4) attending more than one TAFE campus; and 5) not able to read or write in 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)
32 TAFE campuses located in the Hunter and North Coast regions of NSW will take part. TAFE campuses will be matched in pairs according to location, number of enrolments, age groups of students, Aboriginal and Torres Strait Islander origin and types of courses offered and randomly allocated to either the intervention or control condition. A computerised random number function will be used to allocate TAFE campuses into condition. Students at these campuses will be approached during class and those who consent to take part in the trial will be enrolled and will initially be asked to complete the baseline survey using an iPad.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by using a randomisation table created by computer software (i.e. computerised sequence generation). An independent statistician will generate the randomisation table.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to present baseline characteristics of the intervention and control groups. Logistic regression will be used to test if there is a statistically significant difference in change in the prevalence of tobacco smoking between the two treatment groups. The outcome in the model will be smoking status and the predictors will include time, group and an interaction term between time and group. The p-value associated with the interaction term will be used to determine whether there is a statistically significant difference in change between the groups. Linear regression will be used to test whether there is a statistically significant difference in change in the mean level of the other outcomes (standard drinks of alcohol per week, serves of fruit per day, serves of vegetables per day, Mm per week of physical activity) between the two treatment groups. The outcome in the model will be the persons’ value for the measure post treatment, and the predictors will include their baseline value and treatment group (i.e. Analysis of Covariance). The p-value associated with the treatment group will be used to determine if there was a statistically significant difference in change between the groups. Both the logistic and linear regression models will also be fit within a Generalised Estimating Equation framework to adjust for the correlation of responses within TAFEs. Since the number of clusters is relatively small, and even robust methods can underestimate the variance, the Jackknife method will be used to obtain standard errors of estimates. All analyses will be conducted according to the Intention To Treat (ITT) principle and we will use the approach suggested by White and colleagues to handle missing data. The initial analysis will include all available data and will be valid under the assumption that the missing data are missing completely at random. Sensitivity analyses will be conducted under various assumptions about the missing data mechanism.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/05/2018
Actual
Date of last participant enrolment
Anticipated
29/05/2020
Actual
Date of last data collection
Anticipated
27/11/2020
Actual
Sample size
Target
7676
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299348 0
Government body
Name [1] 299348 0
National Health and Medical Research Council (NHMRC)
Country [1] 299348 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 298623 0
None
Name [1] 298623 0
Not applicable
Address [1] 298623 0
Not applicable
Country [1] 298623 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300254 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 300254 0
Ethics committee country [1] 300254 0
Australia
Date submitted for ethics approval [1] 300254 0
Approval date [1] 300254 0
09/10/2017
Ethics approval number [1] 300254 0

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

Contacts
Principal investigator
Name 83062 0
Dr Flora Tzelepis
Address 83062 0
University of Newcastle & Hunter New England Population Health
Locked bag 10
Wallsend NSW 2287
Country 83062 0
Australia
Phone 83062 0
+61249246275
Fax 83062 0
Email 83062 0
Flora.Tzelepis@newcastle.edu.au
Contact person for public queries
Name 83063 0
Flora Tzelepis
Address 83063 0
University of Newcastle & Hunter New England Population Health
Locked bag 10
Wallsend NSW 2287
Country 83063 0
Australia
Phone 83063 0
+61249246275
Fax 83063 0
Email 83063 0
Flora.Tzelepis@newcastle.edu.au
Contact person for scientific queries
Name 83064 0
Flora Tzelepis
Address 83064 0
University of Newcastle & Hunter New England Population Health
Locked bag 10
Wallsend NSW 2287
Country 83064 0
Australia
Phone 83064 0
+61249246275
Fax 83064 0
Email 83064 0
Flora.Tzelepis@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
SourceTitleYear of PublicationDOI
EmbaseUptake of proactively offered online and telephone support services targeting multiple health risk behaviors among vocational education students: Process evaluation of a cluster randomized controlled trial.2021https://dx.doi.org/10.2196/19737
N.B. These documents automatically identified may not have been verified by the study sponsor.