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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12615000165583 |
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Date of registration:
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19/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A stepped wedge cluster randomised controlled trial of a healthy lifestyle intervention for people attending residential substance abuse treatment
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Scientific title:
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A stepped wedge cluster randomised controlled trial of a healthy lifestyle intervention for people attending residential substance abuse treatment |
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Date of first enrolment:
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20/11/2013 |
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Target sample size:
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140 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12615000165583.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Other;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Peter Kelly
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Address:
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School of Psychology, University of Wollongong, Northfields Avenue, Wollongong, NSW, 2500
Australia |
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Telephone:
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+61 2 42392382 |
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Email:
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pkelly@uow.edu.au |
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Affiliation:
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Name:
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Dr Peter Kelly
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Address:
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School of Psychology, University of Wollongong, Northfields Avenue, Wollongong, NSW, 2500
Australia |
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Telephone:
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+61 2 42392382 |
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Email:
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pkelly@uow.edu.au |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Exclusion criteria: (i) people not meeting the eligibility criteria.
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Mental Health - Addiction
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Alcohol and other substance abuse;Mental Health;Cardiovascular disease;Cancer;
Alcohol and other substance abuse
Mental Health
Cardiovascular disease
Cancer
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Cancer - Any cancer
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Cardiovascular - Coronary heart disease
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Intervention(s)
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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.
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Primary Outcome(s)
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Number of cigarettes/day: assessed by the Opiate Treatment Index Tobacco subscale.
[8-weeks, 3-months and 6-months post intervention.]
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Secondary Outcome(s)
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Quality of Life: assessed by the WHO-8 Quality of Life Scale.[6-months post intervention]
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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".[8-weeks, 3-months and 6-months post intervention.]
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Fruit and vegetable consumption: assessed using the fruit subscales taken from the Australian Recommended Food Score (ARFS) index.[8-weeks, 3-months and 6-months post intervention.]
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Level of physical activity and minutes spent walking: assessed by the International Physical Activity Questionnaire.[8-weeks, 3-months and 6-months post intervention.]
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Smoking point prevalent abstinence: 7-day smoking point prevalence abstience self reported by participants.[8-weeks, 3-months and 6-months post intervention.]
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Alcohol and substance use: assessed by the Opiate Treatment Index.[8-weeks, 3-months and 6-months post intervention.]
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Readiness to quit smoking: Smoking Stages of Change (Short Form)[8-weeks, 3-months and 6-months post intervention.]
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Symptom distress: assessed by the Kessler-10.[8-weeks, 3-months and 6-months post intervention.]
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Source(s) of Monetary Support
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Cancer Institute, NSW
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Ethics review
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Status: Approved
Approval date:
Contact:
University of Wollongong Human Research Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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