Contact information
Type
Scientific
Primary contact
Dr Caroline Free
ORCID ID
Contact details
Nutrition and Public Health Research Interventions Unit
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7958 8109
Caroline.Free@lshtm.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol Version 1; G0601639
Study information
Scientific title
Acronym
TXT2STOP
Study hypothesis
TXT2STOP 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
Ethics approval received from the St Thomas' Hospital Research Ethics Committee on the 5th December 2006 (ref: 06/Q0702/169).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Participant information on https://www.txt2stop.org/participant_info.html
Condition
Smoking
Intervention
The 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 type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Self reported abstinence at six months post randomisation. Verified by salivary cotinine testing using a cut-off of 7 ng/ml of cotinine.
Secondary outcome measures
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)
Overall trial start date
30/03/2007
Overall trial end date
29/03/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
5800 - closed to recruitment
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
30/03/2007
Recruitment end date
29/03/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Nutrition and Public Health Research Interventions Unit
London
WC1E 7HT
United Kingdom
Sponsor information
Organisation
London School of Hygiene and Tropical Medicine (UK)
Sponsor details
c/o Penny Ireland
Keppel Street
London
WCIE 7HT
United Kingdom
+44 (0)20 7927 2678
Penny.Ireland@lshtm.ac.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK) (Grant ref no.: G0601639)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20484492
2. 2011n results in http://www.ncbi.nlm.nih.gov/pubmed/21722952
Publication citations
-
Results
Free C, Hoile E, Robertson S, Knight R, Three controlled trials of interventions to increase recruitment to a randomized controlled trial of mobile phone based smoking cessation support., Clin Trials, 2010, 7, 3, 265-273, doi: 10.1177/1740774510367687.
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Free C, Knight R, Robertson S, Whittaker R, Edwards P, Zhou W, Rodgers A, Cairns J, Kenward MG, Roberts I, Smoking cessation support delivered via mobile phone text messaging (txt2stop): a single-blind, randomised trial., Lancet, 2011, 378, 9785, 49-55, doi: 10.1016/S0140-6736(11)60701-0.