ISRCTN ISRCTN80978588
DOI https://doi.org/10.1186/ISRCTN80978588
Protocol serial number Protocol Version 1; G0601639
Sponsor London School of Hygiene and Tropical Medicine (UK)
Funder Medical Research Council (MRC) (UK) (Grant ref no.: G0601639)
Submission date
17/04/2007
Registration date
12/06/2007
Last edited
07/07/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Caroline Free
Scientific

Nutrition and Public Health Research Interventions Unit
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom

Phone +44 (0)20 7958 8109
Email Caroline.Free@lshtm.ac.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific title
Study acronymTXT2STOP
Study objectivesTXT2STOP is a study for a trial of mobile phone text messaging as an aid to support smoking cessation in people in the UK.

The pilot study for this trial has been assigned to ISRCTN37111532 (see http://www.controlled-trials.com/ISRCTN37111532).
Ethics approval(s)Ethics approval received from the St Thomas' Hospital Research Ethics Committee on the 5th December 2006 (ref: 06/Q0702/169).
Health condition(s) or problem(s) studiedSmoking
InterventionThe intervention group will be encouraged to set a quit date within 14 days of randomisation. Five messages per day will be sent in the first five weeks after randomisation.

The control group will receive fortnightly messages on the most well know health dangers of smoking.
Intervention typeOther
Primary outcome measure(s)

Self reported abstinence at six months post randomisation. Verified by salivary cotinine testing using a cut-off of 7 ng/ml of cotinine.

Key secondary outcome measure(s)

1. At four weeks: point prevalence of smoking (as per National Health Service standard reporting)
2. At six months:
2.1. 28-day continuous abstinence
2.2. Involvement in any vehicle crashes (this is the only rare adverse health effects of using a mobile phone)

Completion date29/03/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit16 Years
SexAll
Target sample size at registration5800
Key inclusion criteria1. Aged 16 years and over
2. Currently smoking cigarettes daily and interested in quitting
3. Owner of a mobile phone and familiar with text messaging capabilities
4. Able to provide informed consent to participate in the study
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment30/03/2007
Date of final enrolment29/03/2010

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Nutrition and Public Health Research Interventions Unit
London
WC1E 7HT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2010 Yes No
Results article n results 02/07/2011 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Study website Study website 11/11/2025 11/11/2025 No Yes