Health BehaviourNCT02567097
Evaluating Specific Plans to Increase Smoking Quit Attempts in Prison
A study testing Self-Incentive in people with Health Behaviour, run by University of Manchester at 1 site in United Kingdom.
Trial summary
Tobacco use is the greatest cause of ill health and early mortality, and smoking is the main contributor to around 75,000 deaths a year in England. The aim of the present research is to test the effect of helping people to reward themselves when they have successfully abstained from smoking and the impact this will… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behaviour
- What is being tested?
- Self-Incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 or over
- Able to understand verbal English
- Competent to provide informed consent
- Attending or previously attended the stop smoking services provided
Who cannot join
- Not aged 18 or over
- Not able to understand verbal English
- Not competent to provide informed consent
- Not attending or previously attended the stop smoking services provided
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Self-Incentives in Smoking Cessation: A Randomised Controlled Trial Within a Local Prison
Tobacco use is the greatest cause of ill health and early mortality, and smoking is the main contributor to around 75,000 deaths a year in England. The aim of the present research is to test the effect of helping people to reward themselves when they have successfully abstained from smoking and the impact this will have on subsequent smoking cessation. Each participant will be randomly allocated to one of four conditions. The trial requires 159 participants to perform an fully powered statistical analysis. The four conditions include: (1) a control condition (asked to form a plan to quit smoking), (2) an implementation intention condition (asked to form a more specific 'if-then' plan), (3) baseline which include: (1) a control condition (asked to form a plan to quit smoking), (2) a volitional help sheet condition (asked to link temptations with appropriate behavioural responses), (3) a weekly self-incentivising condition (asked to reward themselves at the end of each week that they have successfully abstained from smoking), or (4) a monthly self-incentivising condition (asked to reward themselves at the end of each month that they have successfully abstained from smoking). The main outcome measure will be smoking quit status, which will be verified biochemically at the end of the stop smoking programme, and at six-months post quit date.
Read the detailed description
The research aims to test the role of self-incentivising implementation intentions in smoking cessation among prisoners aged 18 and over, enrolling on a stop smoking programme provided by Livewire within Risley Prison. The effectiveness of self-incentives has been successfully seen previously within health behaviour change, but not within smoking cessation (ongoing randomised controlled trial in alongside community stop smoking services, and local workplaces). This research will build on this by testing the effectiveness of self-incentives in prisoners' stop smoking attempts.
This study is a randomised controlled trial with the between participants factor of condition which has four levels:
- Control (plan) 2 Self-generated implementation intention (if-then plan) 3. Weekly self-incentivising implementation intention 4. Monthly self-incentivising implementation intention
The within participants' factor will be time which has three levels:
- Baseline (T1)
- Follow-up (T2) (end of stop smoking programme)
- Follow-up (T3) (six months post quit date)
An ethical concern is that participants in the control condition may struggle more to quit smoking as they will not have the additional benefits of being within an experimental condition which uses self-incentives to aid their quit attempt. A control condition is needed to monitor if quitting smoking is due to the use of self-incentives or another behaviour change technique.
The recruitment process will involve the researcher (Emma Brown) administering study packs to the potential participants. The participant information sheet will be read to each participant and time will be provided to ask any questions. If the participant agrees to take part in the research and complete the questionnaire, then this will be completed with the help of the researcher (Emma Brown) if required. Questionnaires will be placed in a sealed envelope and returned to the University of Manchester by the researcher (Emma Brown).
All participants who are able to provide informed consent and are over the age of 18 years old are eligible to take part in the study. Unfortunately, the study does not cater for people who cannot understand English at the present time, although this will be monitored for amendments in future studies. The study will use a paper format as not to exclude those participants who have limited or no access to the internet.
The participant information sheet included within the study pack alongside the questionnaire includes details about the study, costs and benefits of taking part in the study, and the right to consent and withdraw at any point throughout the study. There are no risks involved in taking part in the study. There is a minimal burden in time taken to complete the baseline questionnaire to take no longer than 15 minutes and the further two follow-up questionnaires to take no longer than 10 minutes.
In terms of confidentiality, participants are asked to form a personal identification code to match baseline and follow-up questionnaires once completed.
There are no conflicts of interest. Results will be fed back to all participating services and participants involved in the study, should they indicate for a summary of the results.
- Conditions
- Health Behaviour
- Being tested
- Self-Incentive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-IncentiveBehavioural
Participants are asked to form plans to quit smoking using various descriptions specified dependent on the arm in which they are randomised.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants read a brief statement designed to encourage them to quit smoking (we would like you to plan to quit smoking). Participants are then asked to form their plan to quit smoking. Receives: Behavioral: Self-Incentive |
| Implementation Intention | Active comparator | Participants read a brief statement designed to encourage them to quit smoking (we would like you to plan to quit smoking). Participants are then asked to form a specific 'if-then' plan using an implementation intention basis. Receives: Behavioral: Self-Incentive |
| Weekly Self-Incentivising | Experimental | Participants read a brief statement designed to encourage them to quit smoking (we would like you to plan to quit smoking). Participants are then asked to specify a self-incentive on which they could implement at the end of each week which they have been successful in not smoking. Receives: Behavioral: Self-Incentive |
| Monthly Self-Incentivising | Experimental | Participants read a brief statement designed to encourage them to quit smoking (we would like you to plan to quit smoking). Participants are then asked to specify a self-incentive on which they could implement at the end of each month which they have been successful in not smoking. Receives: Behavioral: Self-Incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking status
Measured: up to 6-months
Secondary outcomes (8)
Amount of cigarettes smoked at both followup time periods
Measured: up to 6-months
Smoking behaviour (habitual)
Measured: up to 6-months
Intentions to stop smoking
Measured: up to 6-months
Self-regulation strategies used
Measured: up to 6-months
Source of motivation to quit smoking
Measured: up to 6-months
Compliance to self-incentivise
Measured: up to 6-months
Frequency of self-incentivisation
Measured: up to 6-months
Self-incentives used
Measured: up to 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviourStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Armitage, University of Manchester
- Investigators
- Christopher J Armitage, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567097
- Sponsor's protocol ID
- 15428
- Status last verified
- May 2018
- First submitted
- 30 Sep 2015
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Brown EM, Smith DM, Armitage CJ. Preliminary evidence that self-incentives uniquely promote smoking cessation in incarcerated populations: A pilot randomized controlled trial. J Subst Use Addict Treat. 2025 Mar;170:209610. doi: 10.1016/j.josat.2024.209610. Epub 2024 Dec 20.
PubMed 39710360
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Self-Incentives in Smoking Cessation: A Randomised Controlled Trial Within a Local Prison
- ClinicalTrials.gov ID
- NCT02567097
- Acronym / sponsor ID
- 15428
- Conditions
- Health Behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tobacco use is the greatest cause of ill health and early mortality, and smoking is the main contributor to around 75,000 deaths a year in England. The aim of the present research is to test the effect of helping people to reward themselves when they have successfully abstained from smoking and the impact this will have on subsequent smoking cessation. Each participant will be randomly allocated to one of four conditions. The trial requires 159 participants to perform an fully powered statistical analysis. The four conditions include: (1) a control condition (asked to form a plan to quit smoking), (2) an implementation intention condition (asked to form a more specific 'if-then' plan), (3) baseline which include: (1) a control condition (asked to form a plan to quit smoking), (2) a volitional help sheet condition (asked to link temptations with appropriate behavioural responses), (3) a weekly self-incentivising condition (asked to reward themselves at the end of each week that they have successfully abstained from smoking), or (4) a monthly self-incentivising condition (asked to reward themselves at the end of each month that they have successfully abstained from smoking). The main outcome measure will be smoking quit status, which will be verified biochemically at the end of the stop smoking programme, and at six-months post quit date.
Detailed description
The research aims to test the role of self-incentivising implementation intentions in smoking cessation among prisoners aged 18 and over, enrolling on a stop smoking programme provided by Livewire within Risley Prison. The effectiveness of self-incentives has been successfully seen previously within health behaviour change, but not within smoking cessation (ongoing randomised controlled trial in alongside community stop smoking services, and local workplaces). This research will build on this by testing the effectiveness of self-incentives in prisoners' stop smoking attempts.
This study is a randomised controlled trial with the between participants factor of condition which has four levels:
- Control (plan) 2 Self-generated implementation intention (if-then plan) 3. Weekly self-incentivising implementation intention 4. Monthly self-incentivising implementation intention
The within participants' factor will be time which has three levels:
- Baseline (T1)
- Follow-up (T2) (end of stop smoking programme)
- Follow-up (T3) (six months post quit date)
An ethical concern is that participants in the control condition may struggle more to quit smoking as they will not have the additional benefits of being within an experimental condition which uses self-incentives to aid their quit attempt. A control condition is needed to monitor if quitting smoking is due to the use of self-incentives or another behaviour change technique.
The recruitment process will involve the researcher (Emma Brown) administering study packs to the potential participants. The participant information sheet will be read to each participant and time will be provided to ask any questions. If the participant agrees to take part in the research and complete the questionnaire, then this will be completed with the help of the researcher (Emma Brown) if required. Questionnaires will be placed in a sealed envelope and returned to the University of Manchester by the researcher (Emma Brown).
All participants who are able to provide informed consent and are over the age of 18 years old are eligible to take part in the study. Unfortunately, the study does not cater for people who cannot understand English at the present time, although this will be monitored for amendments in future studies. The study will use a paper format as not to exclude those participants who have limited or no access to the internet.
The participant information sheet included within the study pack alongside the questionnaire includes details about the study, costs and benefits of taking part in the study, and the right to consent and withdraw at any point throughout the study. There are no risks involved in taking part in the study. There is a minimal burden in time taken to complete the baseline questionnaire to take no longer than 15 minutes and the further two follow-up questionnaires to take no longer than 10 minutes.
In terms of confidentiality, participants are asked to form a personal identification code to match baseline and follow-up questionnaires once completed.
There are no conflicts of interest. Results will be fed back to all participating services and participants involved in the study, should they indicate for a summary of the results.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Self-IncentiveParticipants read a brief statement designed to encourage them to quit smoking (we would like you to plan to quit smoking). Participants are then asked to form their plan to quit smoking. |
| Implementation Intention | Active comparator | Behavioral: Self-IncentiveParticipants read a brief statement designed to encourage them to quit smoking (we would like you to plan to quit smoking). Participants are then asked to form a specific 'if-then' plan using an implementation intention basis. |
| Weekly Self-Incentivising | Experimental | Behavioral: Self-IncentiveParticipants read a brief statement designed to encourage them to quit smoking (we would like you to plan to quit smoking). Participants are then asked to specify a self-incentive on which they could implement at the end of each week which they have been successful in not smoking. |
| Monthly Self-Incentivising | Experimental | Behavioral: Self-IncentiveParticipants read a brief statement designed to encourage them to quit smoking (we would like you to plan to quit smoking). Participants are then asked to specify a self-incentive on which they could implement at the end of each month which they have been successful in not smoking. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 or over
- Able to understand verbal English
- Competent to provide informed consent
- Attending or previously attended the stop smoking services provided
Key exclusion criteria (4 listed)
- Not aged 18 or over
- Not able to understand verbal English
- Not competent to provide informed consent
- Not attending or previously attended the stop smoking services provided
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-IncentiveParticipants are asked to form plans to quit smoking using various descriptions specified dependent on the arm in which they are randomised. | Behavioural | Control, Implementation Intention, Monthly Self-Incentivising, Weekly Self-Incentivising |
Primary outcome
Smoking status
Time frame: up to 6-months
8 secondary outcomes
Amount of cigarettes smoked at both followup time periods
Time frame: up to 6-months
Smoking behaviour (habitual)
Time frame: up to 6-months
Intentions to stop smoking
Time frame: up to 6-months
Self-regulation strategies used
Time frame: up to 6-months
Source of motivation to quit smoking
Time frame: up to 6-months
Compliance to self-incentivise
Time frame: up to 6-months
Frequency of self-incentivisation
Time frame: up to 6-months
Self-incentives used
Time frame: up to 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Derived from this study: PubMed 39710360Brown EM, Smith DM, Armitage CJ. Preliminary evidence that self-incentives uniquely promote smoking cessation in incarcerated populations: A pilot randomized controlled trial. J Subst Use Addict Treat. 2025 Mar;170:209610. doi: 10.1016/j.josat.2024.209610. Epub 2024 Dec 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher J Armitage principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Incentive in people with Health Behaviour, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking status (time frame: up to 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02567097, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.