Skip to main content
Top
Published in: BMC Public Health 1/2015

Open Access 01-12-2015 | Study protocol

Study protocol: a stepped wedge cluster randomised controlled trial of a healthy lifestyle intervention for people attending residential substance abuse treatment

Authors: Peter J Kelly, Amanda L Baker, Frank P Deane, Robin Callister, Clare E Collins, Christopher Oldmeadow, John R Attia, Camilla J Townsend, Isabella Ingram, Gerard Byrne, Carol A Keane

Published in: BMC Public Health | Issue 1/2015

Login to get access

Abstract

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/Design

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.

Discussion

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.

Trial registration

Australian and New Zealand Clinical Trials Register (ANZCTR): ACTRN12615000165​583. Registered 19th February 2015.
Literature
1.
go back to reference Stenbacka M, Leifman A, Romelsjo A. Mortality and cause of death among 1705 illicit drug users: a 37-year follow up. Drug Alcohol Rev. 2009;29:21–7.CrossRef Stenbacka M, Leifman A, Romelsjo A. Mortality and cause of death among 1705 illicit drug users: a 37-year follow up. Drug Alcohol Rev. 2009;29:21–7.CrossRef
2.
go back to reference Rehm J, Gmel G, Sempos CT, Trevisan M. Alcohol-related morbidity and mortality. Alcohol Res Health. 2002;27:39–51. Rehm J, Gmel G, Sempos CT, Trevisan M. Alcohol-related morbidity and mortality. Alcohol Res Health. 2002;27:39–51.
3.
go back to reference Baker A, Ivers RG, Bowman J, Butler T, Kay-Lambkin FJ, Wye P, et al. Where there’s smoke, there’s fire: high prevalence of smoking among some sub-populations and recommendations for intervention. Drug Alcohol Rev. 2006;25:85–96.CrossRefPubMed Baker A, Ivers RG, Bowman J, Butler T, Kay-Lambkin FJ, Wye P, et al. Where there’s smoke, there’s fire: high prevalence of smoking among some sub-populations and recommendations for intervention. Drug Alcohol Rev. 2006;25:85–96.CrossRefPubMed
4.
go back to reference Kelly PJ, Baker AL, Deane FP, Kay-Lambkin FJ, Bonevski B, Tregarthen J. Prevalence of smoking and other health risk factors in people attending residential substance abuse treatment. Drug Alcohol Rev. 2012;5:638–44.CrossRef Kelly PJ, Baker AL, Deane FP, Kay-Lambkin FJ, Bonevski B, Tregarthen J. Prevalence of smoking and other health risk factors in people attending residential substance abuse treatment. Drug Alcohol Rev. 2012;5:638–44.CrossRef
5.
go back to reference McClure EA, Acquavita SP, Dunn KE, Stoller KB, Stitzer ML. Characterizing smoking, cessation services, and quit interest across outpatient substance abuse treatment modalities. J Subst Abuse Treat. 2014;46:194–201.CrossRefPubMed McClure EA, Acquavita SP, Dunn KE, Stoller KB, Stitzer ML. Characterizing smoking, cessation services, and quit interest across outpatient substance abuse treatment modalities. J Subst Abuse Treat. 2014;46:194–201.CrossRefPubMed
7.
go back to reference Hurt RD, Offord KP, Croghan IT, Gomez-Dahl L, Kotte TE, Morse RM, et al. Mortality following inpatient addictions treatment. Role of tobacco use in a community-based cohort. JAMA. 1996;10:1097–103.CrossRef Hurt RD, Offord KP, Croghan IT, Gomez-Dahl L, Kotte TE, Morse RM, et al. Mortality following inpatient addictions treatment. Role of tobacco use in a community-based cohort. JAMA. 1996;10:1097–103.CrossRef
8.
go back to reference Sæland M, Haugen M, Eriksen F-L, Smehaugen A, Wandel M, Böhmer T, et al. Living as a drug addict in Oslo, Norway – a study focusing on nutrition and health. Public Health Nutr. 2008;12:630.CrossRefPubMed Sæland M, Haugen M, Eriksen F-L, Smehaugen A, Wandel M, Böhmer T, et al. Living as a drug addict in Oslo, Norway – a study focusing on nutrition and health. Public Health Nutr. 2008;12:630.CrossRefPubMed
9.
go back to reference Emerson MH, Glovsky E, Amaro H, Nieves R. Unhealthy weight gain during treatment for alcohol and drug use in four residential programs for Latina and African American women. Subst Use Misuse. 2009;44:1553–65.CrossRefPubMed Emerson MH, Glovsky E, Amaro H, Nieves R. Unhealthy weight gain during treatment for alcohol and drug use in four residential programs for Latina and African American women. Subst Use Misuse. 2009;44:1553–65.CrossRefPubMed
10.
go back to reference Kleiner K, Gold M, Frostpineda K, Lenzbrunsman B, Perri M, Jacobs W. Body mass index and alcohol use. J Addict Dis. 2004;23:105–18.CrossRefPubMed Kleiner K, Gold M, Frostpineda K, Lenzbrunsman B, Perri M, Jacobs W. Body mass index and alcohol use. J Addict Dis. 2004;23:105–18.CrossRefPubMed
11.
go back to reference Read JP, Brown RA. The role of physical exercise in alcoholism treatment and recovery. Prof Psychol Res Pract. 2003;34:49–56.CrossRef Read JP, Brown RA. The role of physical exercise in alcoholism treatment and recovery. Prof Psychol Res Pract. 2003;34:49–56.CrossRef
12.
go back to reference Alessi SM, Petry NM. Smoking reductions and increased self-efficacy in a randomized controlled trial of smoking abstinence-contingent incentives in residential substance abuse treatment patients. Nicotine Tob Res. 2014;16:1436–45.CrossRefPubMedPubMedCentral Alessi SM, Petry NM. Smoking reductions and increased self-efficacy in a randomized controlled trial of smoking abstinence-contingent incentives in residential substance abuse treatment patients. Nicotine Tob Res. 2014;16:1436–45.CrossRefPubMedPubMedCentral
13.
go back to reference Eyre H, Kahn R, Robertson RM, Barrett EJ, Mensingon C. Preventing cancer, cardiovascular disease, and diabetes: a common agenda for the American Cancer Society, the American Diabetes Association, and the American Heart Association. Commentary Diabetes Care. 2004;27:1812–24.CrossRef Eyre H, Kahn R, Robertson RM, Barrett EJ, Mensingon C. Preventing cancer, cardiovascular disease, and diabetes: a common agenda for the American Cancer Society, the American Diabetes Association, and the American Heart Association. Commentary Diabetes Care. 2004;27:1812–24.CrossRef
14.
go back to reference Ezzati M, Vanderhoorn S, Rogers A, Lopez A, Mathers C, Murray C. Estimates of global and regional potential health gains from reducing multiple major risk factors. Lancet. 2003;362:271–80.CrossRefPubMed Ezzati M, Vanderhoorn S, Rogers A, Lopez A, Mathers C, Murray C. Estimates of global and regional potential health gains from reducing multiple major risk factors. Lancet. 2003;362:271–80.CrossRefPubMed
15.
go back to reference Spring B, Moller AC, Coons MJ. Multiple health behaviours: overview and implications. J Public Health. 2012;34:i3–10.CrossRef Spring B, Moller AC, Coons MJ. Multiple health behaviours: overview and implications. J Public Health. 2012;34:i3–10.CrossRef
17.
go back to reference Prochaska JJ, Nigg CR, Spring B, Velicer WF, Prochaska JO. The benefits and challenges of multiple health behavior change in research and in practice. Prev Med. 2010;50:26–9.CrossRefPubMed Prochaska JJ, Nigg CR, Spring B, Velicer WF, Prochaska JO. The benefits and challenges of multiple health behavior change in research and in practice. Prev Med. 2010;50:26–9.CrossRefPubMed
18.
go back to reference Read JP, Brown RA, Marcus BH, Kahler CW, Ramsey SE, Dubreuil ME, et al. Exercise attitudes and behaviors among persons in treatment for alcohol use disorders. J Subst Abuse Treat. 2001;21:199–206.CrossRefPubMed Read JP, Brown RA, Marcus BH, Kahler CW, Ramsey SE, Dubreuil ME, et al. Exercise attitudes and behaviors among persons in treatment for alcohol use disorders. J Subst Abuse Treat. 2001;21:199–206.CrossRefPubMed
19.
go back to reference Walsh R, Bowman J, Tzelepis F, Lecathelinais C. Smoking cessation interventions in Australian drug treatment agencies: a national survey of attitudes and practices. Drug Alcohol Rev. 2005;24:235–44.CrossRefPubMed Walsh R, Bowman J, Tzelepis F, Lecathelinais C. Smoking cessation interventions in Australian drug treatment agencies: a national survey of attitudes and practices. Drug Alcohol Rev. 2005;24:235–44.CrossRefPubMed
20.
go back to reference Bowman J, Walsh R. Smoking intervention within alcohol and other drug treatment services: a selective review with suggestions for practical management. Drug Alcohol Rev. 2003;22:73–82.CrossRefPubMed Bowman J, Walsh R. Smoking intervention within alcohol and other drug treatment services: a selective review with suggestions for practical management. Drug Alcohol Rev. 2003;22:73–82.CrossRefPubMed
21.
go back to reference Prochaska JJ, Prochaska JO. A review of multiple health behavior change interventions for primary prevention. Am J Lifestyle Med. 2011;5:208–21.CrossRef Prochaska JJ, Prochaska JO. A review of multiple health behavior change interventions for primary prevention. Am J Lifestyle Med. 2011;5:208–21.CrossRef
22.
go back to reference Prochaska JJ, Delucchi K, Hall SM. A meta-analysis of smoking cessation interventions with individuals in substance abuse treatment or recovery. J Consult Clin Psychol. 2004;72:1144–56.CrossRefPubMed Prochaska JJ, Delucchi K, Hall SM. A meta-analysis of smoking cessation interventions with individuals in substance abuse treatment or recovery. J Consult Clin Psychol. 2004;72:1144–56.CrossRefPubMed
23.
go back to reference Baker A, Kay-Lambkin F, Richmond R, Filia S, Castle D, Williams J, et al. Study protocol: a randomised controlled trial investigating the effect of a healthy lifestyle intervention for people with severe mental disorders. BMC Public Health. 2011;11:10.CrossRefPubMedPubMedCentral Baker A, Kay-Lambkin F, Richmond R, Filia S, Castle D, Williams J, et al. Study protocol: a randomised controlled trial investigating the effect of a healthy lifestyle intervention for people with severe mental disorders. BMC Public Health. 2011;11:10.CrossRefPubMedPubMedCentral
24.
go back to reference Baker AL, Richmond R, Kay-Lambkin FJ, Filia SL, Castle D, Williams JM, et al. Randomised controlled trial of a healthy lifestyle intervention among smokers with psychotic disorders. Nicotine Tob Res. In press, Accepted 12th February, 2015. Baker AL, Richmond R, Kay-Lambkin FJ, Filia SL, Castle D, Williams JM, et al. Randomised controlled trial of a healthy lifestyle intervention among smokers with psychotic disorders. Nicotine Tob Res. In press, Accepted 12th February, 2015.
25.
go back to reference Deane FP, Wootton D, Hsu C, Kelly PJ. Predicting drop out in the first 3 months of 12-step residential drug and alcohol treatment in an Australian sample. J Stud Alcohol Drugs. 2012;73:216–25.CrossRefPubMed Deane FP, Wootton D, Hsu C, Kelly PJ. Predicting drop out in the first 3 months of 12-step residential drug and alcohol treatment in an Australian sample. J Stud Alcohol Drugs. 2012;73:216–25.CrossRefPubMed
26.
go back to reference Deane FP, Kelly PJ, Crowe TP, Coulson JC, Lyons GCB. Clinical and reliable change in an Australian residential substance use program using the addiction severity index. J Addict Dis. 2013;32:194–205.CrossRefPubMed Deane FP, Kelly PJ, Crowe TP, Coulson JC, Lyons GCB. Clinical and reliable change in an Australian residential substance use program using the addiction severity index. J Addict Dis. 2013;32:194–205.CrossRefPubMed
27.
go back to reference Mortlock KS, Deane FP, Crowe TP. Screening for mental disorder comorbidity in Australian alcohol and other drug residential treatment settings. J Subst Abuse Treat. 2011;40:397–404.CrossRefPubMed Mortlock KS, Deane FP, Crowe TP. Screening for mental disorder comorbidity in Australian alcohol and other drug residential treatment settings. J Subst Abuse Treat. 2011;40:397–404.CrossRefPubMed
28.
go back to reference Lyons GCB, Deane FP, Caputi P, Kelly PJ. Spirituality and the treatment of substance use disorders: an exploration of forgiveness, resentment and purpose in life. Addicit Res Theory. 2011;19:459–69.CrossRef Lyons GCB, Deane FP, Caputi P, Kelly PJ. Spirituality and the treatment of substance use disorders: an exploration of forgiveness, resentment and purpose in life. Addicit Res Theory. 2011;19:459–69.CrossRef
29.
go back to reference Mdege ND, Man M-S, Taylor nee Brown C, Torgerson DJ. Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementation. J Clin Epidemiol. 2011;64:936–48.CrossRefPubMed Mdege ND, Man M-S, Taylor nee Brown C, Torgerson DJ. Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementation. J Clin Epidemiol. 2011;64:936–48.CrossRefPubMed
30.
go back to reference Kotz D, Spigt M, Arts ICW, Crutzen R, Viechtbauer W. Researchers should convince policy makers to perform a classic cluster randomized controlled trial instead of a stepped wedge design when an intervention is rolled out. J Clin Epidemiol. 2012;65:1255–6.CrossRefPubMed Kotz D, Spigt M, Arts ICW, Crutzen R, Viechtbauer W. Researchers should convince policy makers to perform a classic cluster randomized controlled trial instead of a stepped wedge design when an intervention is rolled out. J Clin Epidemiol. 2012;65:1255–6.CrossRefPubMed
31.
go back to reference Mdege ND, Man M-S, Taylor nee Brown C, Torgerson DJ. There are some circumstances where the stepped-wedge cluster randomized trial is preferable to the alternative: no randomized trial at all. Response to the commentary by Kotz and colleagues. J Clin Epidemiol. 2012;65:1253–4.CrossRefPubMed Mdege ND, Man M-S, Taylor nee Brown C, Torgerson DJ. There are some circumstances where the stepped-wedge cluster randomized trial is preferable to the alternative: no randomized trial at all. Response to the commentary by Kotz and colleagues. J Clin Epidemiol. 2012;65:1253–4.CrossRefPubMed
34.
go back to reference Darke S, Hall W, Wodak A, Heather N, Ward J. Development and validation of a multidimensional instrument for assessing outcome of treatment among opiate users: the Opiate Treatment Index. Br J Addict. 1992;87:733–42.CrossRefPubMed Darke S, Hall W, Wodak A, Heather N, Ward J. Development and validation of a multidimensional instrument for assessing outcome of treatment among opiate users: the Opiate Treatment Index. Br J Addict. 1992;87:733–42.CrossRefPubMed
35.
go back to reference Sobell LC, Brown J, Leo GI, Sobell MB. The reliability of the Alcohol Timeline Followback when administered by telephone and by computer. Drug Alcohol Depend. 1996;42:49–54.CrossRefPubMed Sobell LC, Brown J, Leo GI, Sobell MB. The reliability of the Alcohol Timeline Followback when administered by telephone and by computer. Drug Alcohol Depend. 1996;42:49–54.CrossRefPubMed
36.
go back to reference Sobell LC, Sobell MB. Timeline follow-back: a technique for assessing self-reported alcohol consumption. New Jersey: Humana Press; 1992.CrossRef Sobell LC, Sobell MB. Timeline follow-back: a technique for assessing self-reported alcohol consumption. New Jersey: Humana Press; 1992.CrossRef
37.
go back to reference Napolitano MA, Borradaile KE, Lewis BA, Whiteley JA, Longval JL, Parisi AF, et al. Accelerometer use in a physical activity intervention trial. Contemp Clin Trials. 2010;31:514–23.CrossRefPubMedPubMedCentral Napolitano MA, Borradaile KE, Lewis BA, Whiteley JA, Longval JL, Parisi AF, et al. Accelerometer use in a physical activity intervention trial. Contemp Clin Trials. 2010;31:514–23.CrossRefPubMedPubMedCentral
38.
go back to reference Ward DS, Evenson KR, Vaughn A, Rodgers AB, Troiano RP. Accelerometer use in physical activity: best practices and research recommendations. Med Sci Sports Exerc. 2005;37:S582–8.CrossRefPubMed Ward DS, Evenson KR, Vaughn A, Rodgers AB, Troiano RP. Accelerometer use in physical activity: best practices and research recommendations. Med Sci Sports Exerc. 2005;37:S582–8.CrossRefPubMed
39.
go back to reference Festinger DS, Marlowe DB, Dugosh KL, Croft JR, Arabia PL. Higher magnitude cash payments improve research follow-up rates without increasing drug use or perceived coercion. Drug Alcohol Depend. 2008;96:128–35.CrossRefPubMedPubMedCentral Festinger DS, Marlowe DB, Dugosh KL, Croft JR, Arabia PL. Higher magnitude cash payments improve research follow-up rates without increasing drug use or perceived coercion. Drug Alcohol Depend. 2008;96:128–35.CrossRefPubMedPubMedCentral
40.
go back to reference Hughes J, Carpenter M. Does smoking reduction increase future cessation and decrease disease risk? A qualitative review. Nicotine Tob Res. 2006;8:739–49.CrossRefPubMed Hughes J, Carpenter M. Does smoking reduction increase future cessation and decrease disease risk? A qualitative review. Nicotine Tob Res. 2006;8:739–49.CrossRefPubMed
41.
go back to reference Diclemente CC, Prochaska JO, Fairhurst S, Velicer WF, Rossi JS, Velasquez M. The process of smoking cessation: an analysis of precontemplation, contemplation and contemplation/action. J Consult Clin Psychol. 1991;59:295–304.CrossRefPubMed Diclemente CC, Prochaska JO, Fairhurst S, Velicer WF, Rossi JS, Velasquez M. The process of smoking cessation: an analysis of precontemplation, contemplation and contemplation/action. J Consult Clin Psychol. 1991;59:295–304.CrossRefPubMed
42.
go back to reference Miller WR, Rollnick S. Motivational interviewing. 3rd ed. New York: Guilford Press; 2012. Miller WR, Rollnick S. Motivational interviewing. 3rd ed. New York: Guilford Press; 2012.
43.
go back to reference Harris RT, Walters ST, Leahy MM. Readiness to change among a group of heavy-drinking college students: correlates of readiness and a comparison of measures. J Am Coll Health. 2008;57:325–30.CrossRefPubMed Harris RT, Walters ST, Leahy MM. Readiness to change among a group of heavy-drinking college students: correlates of readiness and a comparison of measures. J Am Coll Health. 2008;57:325–30.CrossRefPubMed
44.
go back to reference Collins CE, Burrows TL, Rollo ME, Boggess MM, Watson JF, Guest M, et al. The comparative validity and reproducibility of a diet quality index for adults: the Australian Recommended Food Score. Nutrients. 2015;7:785–98.CrossRefPubMedPubMedCentral Collins CE, Burrows TL, Rollo ME, Boggess MM, Watson JF, Guest M, et al. The comparative validity and reproducibility of a diet quality index for adults: the Australian Recommended Food Score. Nutrients. 2015;7:785–98.CrossRefPubMedPubMedCentral
45.
go back to reference Collins CE, Watson JF, Guest M, Boggess MM, Duncanson K, Pezdirc K, et al. Reproducibility and comparative validity of a food frequency questionnaire for adults. Clin Nutr J. 2014;33:906–14.CrossRef Collins CE, Watson JF, Guest M, Boggess MM, Duncanson K, Pezdirc K, et al. Reproducibility and comparative validity of a food frequency questionnaire for adults. Clin Nutr J. 2014;33:906–14.CrossRef
46.
go back to reference NHMRC. Food for health - dietary guidelines for Australian adults. 2003. p. 1–283. NHMRC. Food for health - dietary guidelines for Australian adults. 2003. p. 1–283.
47.
go back to reference Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, et al. International physical activity questionnaire: 12-Country reliability and validity. Med Sci Sports Exerc. 2003;35:1381–95.CrossRefPubMed Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, et al. International physical activity questionnaire: 12-Country reliability and validity. Med Sci Sports Exerc. 2003;35:1381–95.CrossRefPubMed
48.
go back to reference Stark MJ. Dropping out of substance abuse treatment: a clinically oriented review. Clin Psychol Rev. 1992;12:93–116.CrossRef Stark MJ. Dropping out of substance abuse treatment: a clinically oriented review. Clin Psychol Rev. 1992;12:93–116.CrossRef
Metadata
Title
Study protocol: a stepped wedge cluster randomised controlled trial of a healthy lifestyle intervention for people attending residential substance abuse treatment
Authors
Peter J Kelly
Amanda L Baker
Frank P Deane
Robin Callister
Clare E Collins
Christopher Oldmeadow
John R Attia
Camilla J Townsend
Isabella Ingram
Gerard Byrne
Carol A Keane
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2015
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/s12889-015-1729-y

Other articles of this Issue 1/2015

BMC Public Health 1/2015 Go to the issue