Study protocol: a stepped wedge cluster randomised controlled trial of a healthy lifestyle intervention for people attending residential substance abuse treatment.
BACKGROUND
Cardiovascular disease and cancer are leading causes of mortality for people with a history of alcohol or other substance use disorders. These chronic diseases share the same four primary behavioural risk factors i.e. excessive alcohol use, smoking, low intake of fruit and vegetables and physical inactivity. In addition to addressing problematic alcohol use, there is the potential for substance abuse treatment services to also address these other behaviours. Healthy Recovery is an 8-session group-based intervention that targets these multiple behavioural health risk factors and was developed specifically for people attending substance abuse treatment. This protocol describes a Cancer Institute NSW funded study that assesses the effectiveness of delivering Healthy Recovery for people who are attending residential alcohol and other substance abuse treatment.


METHODS
The study uses a stepped wedge randomised controlled design, where randomisation occurs at the service level. Participants will be recruited from residential rehabilitation programs provided by The Australian Salvation Army. All participants who (1) currently smoke tobacco and (2) are expected to be in the residential program for the duration of the 5-week intervention will be asked to participate in the study. Those participants residing at the facilities assigned to the treatment condition will complete Healthy Recovery. The intervention is manual guided and will be delivered over a 5-week period, with participants attending 8 group sessions. All participants will continue to complete The Salvation Army residential program, a predominantly 12-step based, modified therapeutic community. Participants in the control condition will complete treatment as usual. Research staff blind to treatment allocation will complete the primary and secondary outcome assessments at baseline and then at weeks 8, 20 and 32 weeks post intervention.


CONCLUSIONS
This study will provide comprehensive data on the effect of delivering a healthy lifestyle intervention (i.e. Healthy Recovery) within a residential substance abuse setting. If shown to be effective, this intervention can be disseminated within other residential substance abuse programs.


BACKGROUND
Australian and New Zealand Clinical Trials Register (ANZCTR): ACTRN12615000165583. Registered 19(th) February 2015.
Illawarra Institute for Mental Health, School of Psychology, University of Wollongong, Northfields Avenue, Wollongong, 2522, Australia. pkelly@uow.edu.au.
Peter J
PJ
Kelly
School of Medicine and Public Health, Faculty of Medicine, University of Newcastle, University Drive, Callaghan, 2308, Australia. amanda.baker@newcastle.edu.au.
Amanda L
AL
Baker
Illawarra Institute for Mental Health, School of Psychology, University of Wollongong, Northfields Avenue, Wollongong, 2522, Australia. fdeane@uow.edu.au.
Frank P
FP
Deane
School of Biomedical Sciences and Pharmacy, Faculty of Health and Medicine and Priority Research Centre in Physical Activity and Nutrition, University of Newcastle, University Drive, Callaghan, 2308, Australia. Robin.Callister@newcastle.edu.au.
Robin
R
Callister
School of Health Sciences, Faculty of Health and Medicine and Medicine and Priority Research Centre in Physical Activity and Nutrition, University of Newcastle, University Drive, Callaghan, 2308, Australia. Clare.Collins@newcastle.edu.au.
Clare E
CE
Collins
Clinical Research Design, IT and Statistical Support Unit (CReDITSS), Hunter Medical Research Institute, Kookaburra Circuit, New Lambton Heights, 2305, Australia. Christopher.Oldmeadow@newcastle.edu.au.
Christopher
C
Oldmeadow
Clinical Research Design, IT and Statistical Support Unit (CReDITSS), Hunter Medical Research Institute, Kookaburra Circuit, New Lambton Heights, 2305, Australia. John.Attia@newcastle.edu.au.|School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, University Drive, Callaghan, 2308, Australia. John.Attia@newcastle.edu.au.
John R
JR
Attia
Illawarra Institute for Mental Health, School of Psychology, University of Wollongong, Northfields Avenue, Wollongong, 2522, Australia. ct937@uowmail.edu.au.
Camilla J
CJ
Townsend
Illawarra Institute for Mental Health, School of Psychology, University of Wollongong, Northfields Avenue, Wollongong, 2522, Australia. ingram@uow.edu.au.
Isabella
I
Ingram
Recovery Services, Australia Eastern Territory, The Salvation Army, Elizabeth Street, Sydney, 2000, Australia. gerard.byrne@aue.salvationarmy.org.
Gerard
G
Byrne
Illawarra Institute for Mental Health, School of Psychology, University of Wollongong, Northfields Avenue, Wollongong, 2522, Australia. whitbrea@uow.edu.au.
Carol A
CA
Keane
D000428:Alcohol Drinking / Q000628:therapy; D001315:Australia; D002318:Cardiovascular Diseases / Q000517:prevention & control; D005260:Female; D006801:Humans; D008019:Life Style; D008297:Male; D009369:Neoplasms / Q000517:prevention & control; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D012114:Residential Treatment; D012307:Risk Factors; D012907:Smoking / Q000628:therapy*; D016540:Smoking Cessation / Q000379:methods; D019966:Substance-Related Disorders / Q000628:therapy*