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Trial registered on ANZCTR


Registration number
ACTRN12615000105549
Ethics application status
Approved
Date submitted
20/01/2015
Date registered
5/02/2015
Date last updated
5/02/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Targeting Technical and Further Education students’ multiple health risk behaviours via proactively-offered online and telephone interventions
Scientific title
A cluster randomised controlled trial of proactively-offered online and telephone support to reduce smoking, nutrition, alcohol and physical activity health risk behaviours among Technical and Further Education (TAFE) students
Secondary ID [1] 286020 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 293987 0
Alcohol consumption 293988 0
Inadequate fruit and vegetable intake 293989 0
Physical inactivity 293990 0
Condition category
Condition code
Public Health 294286 294286 0 0
Health promotion/education
Diet and Nutrition 294369 294369 0 0
Obesity

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] 291001 0
Prevention
Intervention code [2] 291002 0
Lifestyle
Intervention code [3] 291003 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] 294082 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] 294082 0
6 months post-baseline
Primary outcome [2] 294083 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] 294083 0
6 months post-baseline
Primary outcome [3] 294085 0
Weekly physical activity. Assessed via participant self-report using the Godin Leisure Time Exercise Questionnaire.
Timepoint [3] 294085 0
6 months post-baseline
Secondary outcome [1] 312492 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 [1] 312492 0
6 months post-baseline
Secondary outcome [2] 312493 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 [2] 312493 0
6 months post-baseline
Secondary outcome [3] 312494 0
Body Mass Index
Timepoint [3] 312494 0
6-months post-baseline
Secondary outcome [4] 312659 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 [4] 312659 0
6-months post-baseline
Secondary outcome [5] 312660 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 [5] 312660 0
6-months post-baseline

Eligibility
Key inclusion criteria
TAFE students will be eligible to participate if: 1) enrolled in a TAFE class that runs for at least 12-months; 2) aged 16 years or older; and 3) not meeting Australian health guidelines for at least one of the following health risk behaviours, smoking, nutrition, alcohol or physical activity.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
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; and 4) 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)
TAFE classes will be stratified into vocational type and randomly selected until 100 classes participate. TAFE classes will be matched in pairs according to age groups of students and type of course (e.g. Manufacturing and Engineering, Hairdressing and Beauty) and randomly allocated to either the intervention or control condition. Students 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. A computerised random number function will be used to allocate TAFE classes into condition.
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 for the intervention and control groups. Logistic regression will be used to test if there is a statistically significant different change in the prevalence of 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 if there was a statistically significant difference in change between the groups. Linear regression will be used to test if there is a statistically significant different change in the mean level of the nutrition, alcohol and physical activity outcomes between the groups. The outcome in the model will be the persons’ value of 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 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 classes.

Sample size: As there are 5 primary endpoints (smoking, alcohol consumption, fruit intake, vegetable intake and physical activity) an alpha level of 0.01 will be used to adjust for the multiple comparisons. The prevalence of daily smoking in the control group at follow-up is expected to be 22%. We will recruit 1012 TAFE students at baseline (i.e. 506 per condition). Allowing for 20% loss to follow-up at 6 months, data will be available for 405 participants per condition. With an expected intra-cluster correlation coefficient (ICC) of 0.005 this will give the study a design effect of approximately 1.04 and an effective sample size of 389 per group, which will provide 80% power to find an absolute difference of 9.5% (in daily smoking rates) between the groups at the follow-up visit. Allowing for a higher ICC for the continuous outcomes (0.01), the study will have 80% power to detect an absolute difference of 0.25 SD in these measures at the 1% significance level, which equates to a difference of approximately 1.25 standard drinks of alcohol, 0.25 pieces of fruit, 0.25 vegetables and 50 MET minutes of physical activity.

Recruitment
Recruitment status
Not yet 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
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290613 0
Charities/Societies/Foundations
Name [1] 290613 0
National Heart Foundation of Australia
Address [1] 290613 0
Level 3, 80 William Street
East Sydney NSW 2011
Country [1] 290613 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 289299 0
None
Name [1] 289299 0
Not applicable
Address [1] 289299 0
Not applicable
Country [1] 289299 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292243 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 292243 0
University Drive
Callaghan NSW 2308
Ethics committee country [1] 292243 0
Australia
Date submitted for ethics approval [1] 292243 0
Approval date [1] 292243 0
22/05/2014
Ethics approval number [1] 292243 0
H-2014-0012

Summary
Brief summary
Objective: To examine the effectiveness of proactively offering telephone and online support for reducing health risk behaviours among TAFE students at 6-months follow-up.
Design: A cluster randomised controlled trial.
Methods: A total of 100 TAFE classes (50 per condition) will take part. TAFE classes will be matched in pairs with one randomly allocated to the intervention and the other to the control condition. Eligible TAFE students will be currently enrolled in a class that runs for at least 12-months, be aged 16 years or older and will not be meeting Australian health guidelines for at least one of the following health risk behaviours - smoking, nutrition, alcohol or physical activity. The same students will be surveyed at baseline and 6-months follow-up. Online and telephone support condition: At the 50 intervention classes, effective online programs (i.e. QuitCoach, Healthy Eating Quiz, THRIVE, 10,000 Steps) and telephone support (i.e. Quitline, Get Healthy Information and Coaching Service, Alcohol Drug Information Service) that target health risk behaviours will be proactively offered to TAFE students during class via the baseline computer tablet. Control condition: The 50 TAFE classes in the control condition will not receive any intervention.
Outcome measures: The primary outcomes at the 6-month assessment will assess: 1) tobacco smoking; 2) serves of fruit consumed daily; 3) serves of vegetables consumed daily; 4) standard drinks of alcohol per week and 5) metabolic equivalent minutes of physical activity per week.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54274 0
Dr Flora Tzelepis
Address 54274 0
University of Newcastle & Hunter New Engalnd Population Health
Locked bag 10
Wallsend NSW 2287
Country 54274 0
Australia
Phone 54274 0
+61249246275
Fax 54274 0
Email 54274 0
Flora.Tzelepis@newcastle.edu.au
Contact person for public queries
Name 54275 0
Dr Flora Tzelepis
Address 54275 0
University of Newcastle & Hunter New England Population Health
Locked bag 10
Wallsend NSW 2287
Country 54275 0
Australia
Phone 54275 0
+61249246275
Fax 54275 0
Email 54275 0
Flora.Tzelepis@newcastle.edu.au
Contact person for scientific queries
Name 54276 0
Dr Flora Tzelepis
Address 54276 0
University of Newcastle & Hunter New England Population Health
Locked bag 10
Wallsend NSW 2287
Country 54276 0
Australia
Phone 54276 0
+61249246275
Fax 54276 0
Email 54276 0
Flora.Tzelepis@newcastle.edu.au

No information has been provided regarding IPD availability
Summary results
No Results