Pilot study to evaluate a tailored text message intervention for pregnant smokers (MiQuit): study protocol for a randomised controlled trial

Table 1 Participant assessments at each time point

Participants Assessments	Pre-screen	Visit 1: Baseline	Randomisation	Visit 2: 4 week Follow-up	Visit 3: Late Pregnancy/Postnatal Follow-up	Visit 4: Validation of smoking status
Trial Unit (PS)	X
Acute Unit (PS)	X
Consent^a,b	X					X
Visit Dates^c		X		X	X	X
Demographics/Education		X
Smoking Behaviour 1		X
Smoking Behaviour 2		X
Smoking Behaviour 3						X
Smoking Beliefs		X			X
Pregnancy		X
Relationship Status		X
Eligibility Criteria Check		X
EQ-5D-3 L^d		X		X	X
Allocation - MiQuit/Control			X
Abstinence Check				X
Stop Smoking Strategy/Quit attempts					X
Attitude to Intervention (MiQuit only)^e					X
Assessment of Tobacco Exposure^f						X

^aTelephone and written consent will be performed at Pre-screening.
^bWritten consent for cotinine sample collection will be performed at V4 for those who provided telephone consent at pre-screening.
^cTelephone/face to face visit will be performed at V1 (only) and face to face/postal visit will be performed at V4 (only). Visits 2 and 3 will be telephone, with questionnaires sent to any who cannot be contacted.
^dEQ-5D-3 L - European Quality of life Five Dimension, Three Levels questionnaire to be completed by the participant.
^eA small number of those who are allocated to the MiQuit group and consent at baseline will be contacted for a qualitative telephone interview to provide feedback on their experience of the study and intervention.
^fMeasured with saliva cotinine and/or exhaled CO levels.

ISSN: 1745-6215