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Trial registered on ANZCTR


Registration number
ACTRN12615000165583
Ethics application status
Approved
Date submitted
22/01/2015
Date registered
19/02/2015
Date last updated
29/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A stepped wedge cluster randomised controlled trial of a healthy lifestyle intervention for people attending residential substance abuse treatment
Scientific title
A stepped wedge cluster randomised controlled trial of a healthy lifestyle intervention for people attending residential substance abuse treatment
Secondary ID [1] 286035 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol and other substance abuse 294007 0
Mental Health 294008 0
Cardiovascular disease 294009 0
Cancer 294010 0
Condition category
Condition code
Cancer 294309 294309 0 0
Any cancer
Cardiovascular 294310 294310 0 0
Coronary heart disease
Mental Health 294312 294312 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In addition to completing treatment as usual, participants in the Treatment condition will complete the Healthy Recovery program. The Healthy Recovery program is an 8-session group based healthy lifestyle intervention that was development for people attending residential substance abuse treatment. It is delivered over 5-week period, with two groups being conducted each week for the first 3-weeks, and then 1-group a week conducted during the next two weeks. The first group session is completed over 90 minutes, with subsequent group sessions completed over 60 minutes. The group focuses on helping participants to reduce their smoking, improve their diet and increase their level of physical activity. The intervention involves a combination of health focused psycho-education, goal setting, monitoring, motivational interviewing, and cognitive behavioural therapy. Participants are provided with pedometers to monitor their steps and these are used as a motivational tool for participants. Contingency management is also used to promote reductions in smoking. Where clinically indicated, participants are recommended to commence nicotine replacement therapy (NRT). The group sessions are co-facilitated by a Salvation Army Recovery Service Centre drug and alcohol worker and a member of the research team (i.e. Intern Psychologist or Clinical Psychologist). To track adherence to the intervention, group attendance logs are maintained. Participants are also asked to log of their health behaviours each day (i.e. number of cigarettes, servings of fruit and vegetables, steps walked, minutes of exercise). These logs are photocopied by the research staff and kept to monitor adherence.
Intervention code [1] 291018 0
Lifestyle
Intervention code [2] 291019 0
Behaviour
Intervention code [3] 291020 0
Prevention
Comparator / control treatment
Participants in the control condition complete treatment as usual. This is attendance at residential substance abuse treatment programs provided by the Australian Salvation Army. These programs are up to 10-months in duration, and are delivered as a modified therapeutic community.
Control group
Active

Outcomes
Primary outcome [1] 294117 0
Number of cigarettes/day: assessed by the Opiate Treatment Index Tobacco subscale.
Timepoint [1] 294117 0
8-weeks, 3-months and 6-months post intervention.
Secondary outcome [1] 312531 0
Smoking point prevalent abstinence: 7-day smoking point prevalence abstience self reported by participants.
Timepoint [1] 312531 0
8-weeks, 3-months and 6-months post intervention.
Secondary outcome [2] 312532 0
Fruit and vegetable consumption: assessed using the fruit subscales taken from the Australian Recommended Food Score (ARFS) index.
Timepoint [2] 312532 0
8-weeks, 3-months and 6-months post intervention.
Secondary outcome [3] 312533 0
Level of physical activity and minutes spent walking: assessed by the International Physical Activity Questionnaire.
Timepoint [3] 312533 0
8-weeks, 3-months and 6-months post intervention.
Secondary outcome [4] 312534 0
Alcohol and substance use: assessed by the Opiate Treatment Index.
Timepoint [4] 312534 0
8-weeks, 3-months and 6-months post intervention.
Secondary outcome [5] 312535 0
Quality of Life: assessed by the WHO-8 Quality of Life Scale.
Timepoint [5] 312535 0
6-months post intervention
Secondary outcome [6] 312536 0
Symptom distress: assessed by the Kessler-10.
Timepoint [6] 312536 0
8-weeks, 3-months and 6-months post intervention.
Secondary outcome [7] 312931 0
Quit attempts: Partcipants are asked to report the number of serious quit attempts made since the previous assessment. The following explanation is read to participants to describe serious quit attempts: "By serious attempt I mean you decided that you would try to make sure you never smoked again. Please include any attempt that you are currently making and please include any successful attempt made since we last spoke".
Timepoint [7] 312931 0
8-weeks, 3-months and 6-months post intervention.
Secondary outcome [8] 312932 0
Readiness to quit smoking: Smoking Stages of Change (Short Form)
Timepoint [8] 312932 0
8-weeks, 3-months and 6-months post intervention.

Eligibility
Key inclusion criteria
(i) a current smoker, and (ii) attending The Salvation Army Recovery Service Centre and expected to be a client of the facility for the duration of the 5-week program.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) people not meeting the eligibility criteria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The proposed study will be conducted as a stepped-wedge cluster randomised trial, where randomisation will occur at the service level. At each step of the study design, a presentation will be made to the participants of each of the Salvation Army Recovery Service Centres asking for participants to join the study. Participants who are interested in being involved in the study will be asked to complete a checklist confirming their eligibility to participate in the study (i.e. that they are a smoker and that they expect to be at the residential facility for the duration of the 5-week intervention). The research assistant providing this presentation and supervising the completion of the eligibility checklist will be blind to the randomisation sequence, and in the first and final steps will be blind to both the randomisation sequence and the stepped wedge study design (i.e. we will use different research assistants to provide these presentations to ensure blindness to the stepped wedge design). The randomisation schedule will be kept centrally, with the blinded research assistant not being made aware of the randomisation schedule until all participants at each site have confirmed their eligibility.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation procedures will be managed independently at the Clinical Research Design, IT, and Statistical Support Unit, University of Newcastle, NSW. Using a stepped-wedge design, each residential substance service will begin the study as a control site, providing TAU to participants (Control). Sites will then progressively commence the Healthy Recovery program and will begin contributing to the intervention arm of the study in a stepped fashion (Treatment). Independent statisticians will randomly generate the order of the sites using permitted block randomisation, with the sample of services used as the block.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
The study is being conducted as a stepped-wedge cluster randomised trial.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The primary outcome is number of cigarettes/day at 8 weeks follow-up and pilot data suggests this has a SD of 12 cigarettes/day. Assuming a baseline/follow-up correlation of 0.25 we would need a sample of 85 before and 85 after intervention to give the study 80% power to detect a 5 cigarette/day intervention effect at a 5% significance level. We have added another 15% to allow for non-parametric distribution of the data, i.e. 98 people before and after. To account for loss to follow-up we have added another 40% (based on previous RCT’s conducted by the researchers), yielding about 140 people before and after.

Since the number of clusters is small, we will use a fixed effects linear regression model to assess the effect of the intervention. The outcome variable will be number of cigarettes/day at 8 weeks, 3-months and 6-months follow-up. Baseline number of cigarettes/day will be included as a covariate. We will include a fixed effect for treatment centre, which accounts for differences in the average level of the outcome across centres and the association between before/after and centre induced by the stepped-wedge design. The main predictor of interest will be a before/after intervention variable, which would be at a different time point for each centre and will measure the intervention effect, which after adjusting for centre is a weighted average of the effect within each centre. Time will be included in the model as a continuous measure to account for any secular trends. We will use robust Huber-White estimates of the standard error to account for any violations in the assumption of normality of residuals. The data will be analysed following the intent-to-treat principal. The primary analysis will be a complete case analysis, with sensitivity analysis undertaken to include all participants under an appropriate model for missing data such as multiple imputation. Analysis conducted independently by statisticians in the Clinical Research Design, IT and Statistical Support Unit, University of Newcastle, under the supervision of AI Attia

Recruitment
Recruitment status
Completed
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)
ACT,NSW
Recruitment postcode(s) [1] 9139 0
2259 - Dooralong
Recruitment postcode(s) [2] 9140 0
2600 - Canberra
Recruitment postcode(s) [3] 9142 0
2780 - Leura
Recruitment postcode(s) [4] 9143 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 290627 0
Government body
Name [1] 290627 0
Cancer Institute, NSW
Address [1] 290627 0
Australian Technology Park, Level 9, 8 Central Avenue, EVELEIGH NSW 2015, AUSTRALIA
Country [1] 290627 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Avenue, University of Wollongong, Wollongong, NSW, Australia 2500
Country
Australia
Secondary sponsor category [1] 289319 0
None
Name [1] 289319 0
Address [1] 289319 0
Country [1] 289319 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292264 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 292264 0
Northfields Avenue
University of Wollongong, Wollongong, New South Wales, 2500
Ethics committee country [1] 292264 0
Australia
Date submitted for ethics approval [1] 292264 0
Approval date [1] 292264 0
31/10/2013
Ethics approval number [1] 292264 0
HE13/365

Summary
Brief summary
This study will determine whether administering a healthy lifestyle intervention targeting multiple cancer risk factors, namely smoking, poor diet and physical inactivity, will change behaviours among people attending residential substance abuse treatment. The study will be conducted with people who are attending The Salvation Army Recovery Service Centres located in New South Wales and the Australian Capital Territory, Australia. You may be eligible to join this study if you are aged 18 years or above, have an alcohol or other substance abuse dependence disorder and are attending The Salvation Army Recovery Service Centre.

Study details: Cardiovascular disease and cancer are leading causes of mortality for people with a history of substance abuse problems and it requires prevention strategies that address primary risk factors such as smoking, poor diet, and physical inactivity. The current project will trial the Healthy Recovery Program, a group based intervention that targets multiple cancer risk factors. Each service centre will be randomly allocated (by chance) to one of two programs: a Healthy Recovery program or the usual residential substance abuse treatment program provided by the Salvation Army. The Healthy Recovery program focuses on helping participants to reduce their smoking, improve their diet and increase their level of physical activity in a group setting. The intervention involves a combination of health focused psycho-education, goal setting, monitoring, motivational interviewing, and cognitive behavioural therapy. Participants will be asked to complete a number of questionnaires at 8-weeks, 3-months and 6 months post-intervention to assess frequency of smoking, fruit and vegetable consumption, physical activity, alcohol and substance use, quality of life and mental health. Results from this study will inform the development and implementation of multiple health behaviour change interventions for other marginalised populations.
Trial website
Trial related presentations / publications
Kelly, P.J., Baker, A.L., Deane, F.P., Callister, R., Collins, C.E., Oldmeadow, C.J., Attia, J.R., Townsend, C.J., Ingram, I., Byrne, G., & Keane, C.A. (2015). Study protocol: a stepped wedge cluster randomised controlled trial of a healthy lifestyle intervention for people attending residential substance abuse treatment. BMC Public Health, 15(1): 465. DOI:10.1186/s12889-015-1729-y.

Kelly, P.J., Baker, A.L., and Kay-Lambkin, F.J. (2014). Addressing multiple health risk behaviours in disadvantaged populations: Research being led by the NHMRC Centre of Research Excellence In Mental Health and Substance Use. Abstract presented at the Australasian Professional Society on Alcohol and other Drugs (APSAD) Conference. Adelaide, South Australia. Abstract in Drug and Alcohol Review, 33 (Special Issue).

Kelly, P.J. (2015). Opportunities and strategies for improving the healthy behaviours of people accessing alcohol or other substance abuse treatment: Pilot findings and early RCT results. Treatment Research Institute. Philadelphia, United States (Fully paid speaker invitation).

Kelly, P.J. (2015). Opportunities to improve the health behaviors of people experiencing substance abuse problems and other mental illnesses. Asher Center for the Study and Treatment of Depressive Disorders, Feinberg School of Medicine, Northwestern University. Chicago, United States.

Kelly, P.J. (2015). Improving the health behaviours of people living with substance abuse problems and other severe mental illnesses: Results from healthy lifestyle focused trials. Addiction Seminar, Department of Psychiatry and Behavioural Sciences, Feinberg School of Medicine, Northwestern University. Chicago, United States.

Kelly, P.J. (2015). Alcohol and other substance abuse treatment: the challenges and opportunities. Department of Psychology, Colorado State University. Fort Collins, United States.
Public notes

Contacts
Principal investigator
Name 54346 0
Dr Peter Kelly
Address 54346 0
School of Psychology, University of Wollongong, Northfields Avenue, Wollongong, NSW, 2500
Country 54346 0
Australia
Phone 54346 0
+61 2 42392382
Fax 54346 0
Email 54346 0
pkelly@uow.edu.au
Contact person for public queries
Name 54347 0
Dr Peter Kelly
Address 54347 0
School of Psychology, University of Wollongong, Northfields Avenue, Wollongong, NSW, 2500
Country 54347 0
Australia
Phone 54347 0
+61 2 42392382
Fax 54347 0
Email 54347 0
pkelly@uow.edu.au
Contact person for scientific queries
Name 54348 0
Dr Peter Kelly
Address 54348 0
School of Psychology, University of Wollongong, Northfields Avenue, Wollongong, NSW, 2500
Country 54348 0
Australia
Phone 54348 0
+61 2 42392382
Fax 54348 0
Email 54348 0
pkelly@uow.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary