Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000217303
Ethics application status
Approved
Date submitted
24/11/2016
Date registered
9/02/2017
Date last updated
21/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled study of the Health Intervention “SNAP” in Northern Territory prisons- where smoking is banned- to prevent relapse to smoking
Scientific title
A randomised controlled study of the Health Intervention “SNAP” in Northern Territory prisons- where smoking is banned- to prevent relapse to smoking
Secondary ID [1] 290620 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SNAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco Smoking 301120 0
Nutrition 301121 0
Alcohol Use 301122 0
Physical Activity levels 301123 0
Condition category
Condition code
Public Health 300892 300892 0 0
Health promotion/education
Mental Health 301001 301001 0 0
Addiction
Diet and Nutrition 301002 301002 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants who are randomly allocated to the intervention group will receive one session of 30 to 60 minutes of SNAP brief intervention, which aims to improve participants’ health, specifically through preventing them from returning to Smoking, improving their Nutrition through healthier eating, reducing or ceasing Alcohol consumption and increasing Physical activity.

A Clinical Psychologist Consultant with 25 years' experience designed the SNAP intervention for this trial based on the theoretical model of Motivational Interviewing. Four research assistants who are trained by the Clinical Psychologist Consultant and have passed the qualification assessment will deliver the intervention face-to-face in a prison interview room after the baseline interview, which is within two weeks before the participants' release date. An illustrative SNAP pamphlet will be given to the participants to facilitate the intervention.

The SNAP intervention will focus on Smoking in an attempt to maintain abstinence after prison release. The delivery of the SNAP intervention relies on the 5A’s framework, which is adopted in the SNAP guide by the Royal Australian College of General Practitioners (RACGP):
1. Ask (identify risk factors for smoking and affirm choice not to smoke)
2. Assess (assess the level of motivation and their readiness to change)
3. Advise (provide feedback, advice and motivational interviewing based on readiness level),
4. Assist (develop a strategic and risk management plans and provide support for self-monitoring)
5. Arrange (refer to special services, offer Quitline phone counselling information, arrange follow-up with GP).

Participants identified as having other risk factors will receive advice on how to modify their risk as per below:
1. Poor Nutrition: Give brief advice according to Australian Guide to Healthy Eating and refer to eatforhealth.gov.au website.
2. Hazardous drinking: Referral to drug and alcohol services.
3. Physical inactivity: Give brief advice based on Australian's Physical Activity and Sedentary Behaviour Guidelines.

At the end of the intervention, participants will receive a pre-release bag which contains:
- Australian Guide to Healthy Eating posters
- Australian's Physical Activity and Sedentary Behaviour Guidelines for Adults (18-64 years) posters
- Quitline posters and magnet
- My Quitbuddy App Card
- Follow-up card with 'My Health, My Family, My Pocket.' printed on the back.

Participant engagement underlies the success of the SNAP intervention. Therefore the intervention is designed to be a client-centred conversation that will be tailored to individual participant's interest and motivation during the session. Intervention fidelity will be assessed in a two-weeks pilot where two intervention sessions for each research assistant will be audiotaped. The Clinical Psychologist Consultant will review the audio records and provide feedback. We will maintain intervention adherence by randomly select one session every month for each research assistant to be audio-recorded, and reviewed with feedback by the Consultant.
Intervention code [1] 296495 0
Lifestyle
Intervention code [2] 296982 0
Behaviour
Intervention code [3] 296983 0
Prevention
Comparator / control treatment
The control group will receive Northern Territory prison standard care, which is a pre-release written general health referral to the participant's local health centre.
Control group
Active

Outcomes
Primary outcome [1] 300298 0
The primary outcome is the between-group difference in the proportion of smoking abstinence on Day 90 post-prison release.

Smoking abstinence in this study is defined as self-reported smoking abstinence over the whole follow-up period allowing up to five cigarettes in total, along with biochemical verification using exhaled Breath Carbon Monoxide (eBCO) testing within 7 days after reporting.

Self-reported smoking abstinence will be assessed by face-to-face or phone interview or mailed questionnaire. For those who report smoke-free, eBCO test will be performed according to manufactural protocol at the end of the face-to-face interview or within 7 days after phone interview or receipt of mailed questionnaire at a community health centre appointment.
Timepoint [1] 300298 0
The primary outcome will be measured after 90 days from prison release.
Secondary outcome [1] 329648 0
The number of cigarettes smoked on day 1 and 2 post-release, as well as the total number of cigarettes smoked by day 7, 30 and 90 after release using a modified Timeline Follow-Back method.
Timepoint [1] 329648 0
The number of cigarettes smoked will be measured at the 90-days follow-up interview from prison release. Participants will be asked to recall the number of cigarettes they smoke on day 1, 2, 7, 30 and 90 days post release at the follow-up interview.
Secondary outcome [2] 331465 0
Nutrition: healthy dietary habits

Healthy dietary habits will be assessed by adherence to average daily servings recommended by the Australian Dietary Guidelines 2013. Short questions will be asked to measure participants’ eating from five food groups: fruit, grains, meat/poultry, dairy and vegetables.
Timepoint [2] 331465 0
Secondary outcomes will be measured after 90 days from prison release.
Secondary outcome [3] 331466 0
Alcohol consumption

Alcohol use will be measured using the Alcohol Use Disorder Identification Test –Alcohol Consumption Questions (AUDIT-C) via face-to-face or phone interview.
Timepoint [3] 331466 0
Secondary outcomes will be measured after 90 days from prison release.
Secondary outcome [4] 331467 0
Physical activity

Self-reported physical activity will be measured using the International Physical Activity Questionnaire via face-to-face or phone interview.
Timepoint [4] 331467 0
Secondary outcomes will be measured after 90 days from prison release.
Secondary outcome [5] 331469 0
Quality of life

Quality of life will be measured using the EuroQol five dimensions questionnaire (EQ-5D) via face-to-face or phone interview.
Timepoint [5] 331469 0
Secondary outcomes will be measured after 90 days from prison release.
Secondary outcome [6] 331477 0
Health service utilisation

Pharmaceutical Benefits Scheme (PBS) and Medication Benefits Scheme (MBS) data will be requested from the Department of Human Service.

Hospital admission, emergency department admission and primary health care visit data will be requested from Department of Health.

National Death Index will be requested from Australian Insitute of Health and Welfare.
Timepoint [6] 331477 0
Health service utilisation will be requested from 3 years before baseline to 2 years after.
Secondary outcome [7] 342251 0
Time to first cigarette (TTFC) after release. TTFC will be asked in a multiple-choice question with the following choices: (1) “on the day of release”; (2) “on the second day after release”; (3) “not the first two days but within a week after release”; (4) “not the first week but within a month after release”; (5) “not the first month but within three months after release”; and (6) “I did not smoke after release”.
Timepoint [7] 342251 0
Secondary outcomes will be measured after 90 days from prison release.

Eligibility
Key inclusion criteria
Inclusion criteria are (a) ex-daily smoker before entering a Northern Territory prison (b) to be in a Northern Territory (NT) prison from October 2016 to June 2018; (c) be released from a NT prison from January 2017 to June 2018; (d) want to stay smoking-free after release;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria are (a) current diagnosis of a severe psychiatric disorder or (b) intent to harm self or others or (c) impaired decision making capacity.

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)
Allocation concealment will be achieved using central randomisation by the trial coordinator who will not participate in study interview or assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule, developed by NDARC’s statistician, will equally randomise participants into intervention and usual care groups. Randomisation will occur independently within each of the two participating NTDCS centres.

The method used will be simple randomisation using a randomisation table created by computer software, administered by a senior statistician (i.e. computerised sequence generation)
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
Sample Size Calculation

One previous study in the U.S. reported that a behavioural intervention before prison release significantly increased smoking abstinence in the community at week 3 (25% vs. 7%) and week 12 (12% vs. 2%) compared to a control group (Clark et al., JAMA Intern Med, 2013).

We expect the proportion of sustained smoking abstinence at 90-days post-release to be 8% and 2% (odds ratio = 4.0) in the intervention and control groups, respectively. With 80% power at 0.05 significance level, a sample size of 412 is calculated using two-sample proportions test, with 206 in each group. Taking into account 50% loss to follow-up, we will enrol 824 inmates at baseline. Assume a 70% of inmates interviewed will be eligible and agree to be included in the study, we will need to screen 1,178 inmates.

Statistical Analysis:

The primary analysis will be an intention to treat analysis (ITT), with a p-value of <0.05 considered statistically significant. The absolute difference in point prevalence of smoking abstinence post-release will be compared between the intervention and control groups using analysis of variance (ANOVA).

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
20/02/2017
Actual
3/04/2017
Date of last participant enrolment
Anticipated
1/06/2018
Actual
23/03/2018
Date of last data collection
Anticipated
1/10/2018
Actual
Sample size
Target
824
Accrual to date
Final
557
Recruitment in Australia
Recruitment state(s)
NT

Funding & Sponsors
Funding source category [1] 295055 0
Government body
Name [1] 295055 0
Australian Commonwealth (Department of Health)
Country [1] 295055 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
National Drug and Alcohol Research Centre
University of New South Wales
Sydney NSW 2052, Australia
Country
Australia
Secondary sponsor category [1] 293866 0
None
Name [1] 293866 0
None
Address [1] 293866 0
NA
Country [1] 293866 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296401 0
University of New South Wales Ethics Committee
Ethics committee address [1] 296401 0
University of New South Wales
Sydney NSW 2052, Australia
Ethics committee country [1] 296401 0
Australia
Date submitted for ethics approval [1] 296401 0
28/09/2016
Approval date [1] 296401 0
02/11/2016
Ethics approval number [1] 296401 0
HC16732

Summary
Brief summary
The Northern Territory (NT) prison population comprises 92% Indigenous Australians and 88% smokers. The NT prison smoking ban creates a population-wide abstinence. 864 men will be randomised to receive the Health Intervention SNAP (Smoking, Nutrition, Alcohol and Physical activity), or usual care (control group). Released participants will be followed up to examine relapse to smoking at Day 30 and 90 post-release. An additional outcome will be the comparison of the two groups on Nutrition, Alcohol and Physical activity risk factors post-release. Participant records will also be prospectively linked with PBS, Medicare, AIHW, and PHRN records.
Trial website
https://ndarc.med.unsw.edu.au/project/randomised-controlled-study-health-intervention-snap-northern-territory-prisons
Trial related presentations / publications
Public notes
Attachments [1] 1266 1266 0 0
/AnzctrAttachments/371923-UNSW ethics approval.Pdf (Ethics approval)

Contacts
Principal investigator
Name 70750 0
Prof Kate Dolan
Address 70750 0
NDARC
University of New South Wales
Sydney NSW 2052, Australia
Country 70750 0
Australia
Phone 70750 0
+61 2 9385 0333
Fax 70750 0
Email 70750 0
[email protected]
Contact person for public queries
Name 70751 0
Prof Kate Dolan
Address 70751 0
NDARC
University of New South Wales
Sydney NSW 2052, Australia
Country 70751 0
Australia
Phone 70751 0
+61 2 9385 0333
Fax 70751 0
Email 70751 0
[email protected]
Contact person for scientific queries
Name 70752 0
Prof Kate Dolan
Address 70752 0
NDARC
University of New South Wales
Sydney NSW 2052, Australia
Country 70752 0
Australia
Phone 70752 0
+61 2 9385 0333
Fax 70752 0
Email 70752 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBrief intervention on Smoking, Nutrition, Alcohol and Physical (SNAP) inactivity for smoking relapse prevention after release from smoke-free prisons: A study protocol for a multicentre, investigator-blinded, randomised controlled trial.2018https://dx.doi.org/10.1136/bmjopen-2017-021326
N.B. These documents automatically identified may not have been verified by the study sponsor.