Evaluating specific plans to increase smoking quit attempts
| ISRCTN | ISRCTN11610200 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11610200 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | University of Manchester |
| Funder | University of Manchester (UK) |
- Submission date
- 02/10/2014
- Registration date
- 27/11/2014
- Last edited
- 13/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Smoking is the greatest cause of ill health with approximately 18% of deaths in England being associated with smoking. Providing people with incentives (e.g., money, vouchers) seems to be an effective way of helping people to quit smoking, but incentives administered by others may alter underlying motivation to quit and result in people starting up smoking again. Encouraging people to reward themselves (e.g., inviting friends round) could overcome these difficulties, yet people seem reluctant to do this. The aim of this study is to test if such “self-incentives” result in an increase in the number of people already attending community stop smoking services, and workplaces, quitting the habit. The study investigates whether an “if-when” plan (e.g., If I successfully abstain from smoking for a week, then I will reward myself by inviting friends around) can help people to stop smoking, what kind of self-incentives do lead people to stop smoking and the ideal rate of self-incentivising towards successfully quitting smoking.
Who can participate?
Any person aged 18 years or over who has approached one of the participating stop smoking services (or workplaces) and is smoking at the time of enrolment on to the program
What does the study involve?
Participants are randomly allocated into one of four groups. Those in group 1 (active control) are asked to form a plan to help them to quit smoking. Those in group 2 (active control) are asked to link suitable temptations to smoke with an appropriate response (using a list of 20 temptations and 20 responses through a planner known as the volitional help sheet). Those in group 3 (intervention) are asked to complete an 'if-then' plan which includes a self-incentive that can be used for each week that they have successfully quit smoking. Those in group 4 (intervention) are asked to complete an 'if-then' plan which includes a self-incentive that can be used for each month that they have successfully quit smoking. Participants are also asked about their smoking habits, nicotine dependence, thoughts, feelings and motivation towards the smoking quit attempts at the start of the trial, at the end of the trial (12 weeks later), and 6 months after the start of the trial. The repetition and agreement to self-incentivising are measured at the end of the trial and 6 months after the start of the trial.
What are the possible benefits and risks of participating?
Participants who complete an 'if-then' plan which includes a self-incentive may benefit from their participation by the intervention helping them to successfully quit smoking. There are no risks to taking part in the study.
Where is the study run from?
The stop smoking services in which participants are recruited are held in various health and community centres across North West England (UK). The workplaces in which participants are recruited are based in North West England (UK).
When is the study starting and how long is it expected to last?
October 2014 to September 2020
Who is funding the study?
University of Manchester (UK)
Who is the main contact?
Emma Brown
Emma.Brown@uea.ac.uk
Contact information
Scientific
Manchester Centre for Health Psychology
School of Health Sciences
Division of Psychology and Mental Health
University of Manchester
Coupland Street
Oxford Road
Manchester
M13 9PL
United Kingdom
| chris.armitage@manchester.ac.uk |
Public
School of Health Sciences
Faculty of Medicine and Health Sciences
University of East Anglia
Edith Cavell Building
Norwich
NR4 7UL
United Kingdom
 ORCID ID |
0000-0002-4753-3774 |
|---|---|
| Emma.Brown@uea.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-site parallel randomised controlled trial |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | The role of self-incentives in smoking cessation: a randomised controlled trial in community-based stop smoking services |
| Study objectives | The main hypotheses are that: 1. Self-incentives will increase the number of participants who successfully quit smoking at follow-up. 2. Self-incentivising at the end of the week will be more effective at aiding smoking cessation than self-incentivising at the end of the month. 3. Providing smokers with self-incentives will be more effective at aiding smoking cessation than asking smokers to generate their own self-incentives. 4. Specific implementation intentions will be more effective at aiding smoking cessation than general implementation intentions. |
| Ethics approval(s) |
Approved 12/09/2014, North West - Greater Manchester West Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 207 1048007; gmwest.rec@hra.nhs.uk), ref: 14/NW/1262 |
| Health condition(s) or problem(s) studied | A psychological health intervention within a smoking population |
| Intervention | Participants will be randomised to one of four groups: 1. To form a plan to help to quit smoking (active control) 2. To complete the volitional help sheet (active control) 3. To complete an 'if-then' plan which includes a self-incentive that can be used for each week that they have successfully quit smoking (intervention) 4. To complete an 'if-then' plan which includes a self-incentive that can be used for each month that they have successfully quit smoking (intervention) |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Increase in smoking quit status at six-months post baseline (self-reported) |
| Key secondary outcome measure(s) |
1. Increase in smoking quit status at the end of the trial (12 weeks after baseline) |
| Completion date | 30/09/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 477 |
| Total final enrolment | 633 |
| Key inclusion criteria | 1. Aged 18 or over 2. Able to understand written and verbal English 3. Competent to provide informed consent 4. Attending one of the stop smoking services or workplaces currently involved in the trial |
| Key exclusion criteria | 1. Under 18 years of age 2. Unable to understand written and verbal English 3. Not competent to provide informed consent 4. Attending a stop smoking service or workplace which isn't within those listed above |
| Date of first enrolment | 02/12/2014 |
| Date of final enrolment | 30/09/2020 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
M13 9PL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/03/2019 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/07/2023: The total final enrolment was added.
30/07/2018: Publication reference added.
26/10/2017: The target number of participants was changed from 4140 to 477 across the three RCTs.
20/07/2017: The overall trial end date was changed from 30/09/2016 to 30/09/2020.
