NCT02567097

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

1.9 years

First QC Date

September 30, 2015

Last Update Submit

May 1, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Smoking status

    up to 6-months

Secondary Outcomes (8)

  • Amount of cigarettes smoked at both followup time periods

    up to 6-months

  • Smoking behaviour (habitual)

    up to 6-months

  • Intentions to stop smoking

    up to 6-months

  • Self-regulation strategies used

    up to 6-months

  • Source of motivation to quit smoking

    up to 6-months

  • +3 more secondary outcomes

Study Arms (4)

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.

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.

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.

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.

Behavioral: Self-Incentive

Interventions

Self-IncentiveBEHAVIORAL

Participants are asked to form plans to quit smoking using various descriptions specified dependent on the arm in which they are randomised.

ControlImplementation IntentionMonthly Self-IncentivisingWeekly Self-Incentivising

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 or over
  • Able to understand verbal English
  • Competent to provide informed consent
  • Attending or previously attended the stop smoking services provided

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Risley Prison

Warrington, Cheshire, WA3 6BP, United Kingdom

Location

Study Officials

  • Christopher J Armitage

    University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Christopher Armitage

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 2, 2015

Study Start

January 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 4, 2018

Record last verified: 2018-05

Locations