Pollak 2013.

Methods	This 2‐armed randomised controlled trial aimed to determine the acceptability of a SMS text based Scheduled gradual reduction (SGR) intervention plus support messages to promote cessation during pregnancy. This study was conducted in the USA with women recruited from 4 clinics, including a county health department that provides care for uninsured and underinsured patients as well as a U.S. Army medical center.
Participants	Inclusion criteria: > 18 years of age, English‐speaking, have smoked at least 100 cigarettes in their lifetime, smoked 5 or more cigarettes per day in the prior 7 days, are willing to try quit smoking, are between 10 and 30 weeks pregnant, and have a cell phone with unlimited texting. Exclusion criteria: Women were excluded if they could not properly provide consent. Recruitment: 31/64 = 48% participation rate (C = 15 I = 16) Study staff obtained written consent from women. Baseline characteristics: Mean Age (C = 27 I = 29) Mean number of cigarettes per day (C = 10 I = 10) Partner smokes (C = 87% I = 56%) Further than high school (C = 53% I = 38%). Progress + coding: None.
Interventions	Control: SMS support messages, women were asked to choose a quit date within the next 2‐3 weeks and then texted them that quit date. Staff explained that women would receive up to 5 messages per day for 5 weeks. Each week there was a new theme for a subset of messages, such as reasons for quitting, getting ready for quit date, partner smoking and handling slips. Intervention: Support messages plus a scheduled gradual reduction (SGR) Staff told women randomised to support messages plus SGR that they would receive support messages for 5 weeks as described in Support Messages Alone section. Instead of setting a quit date within 2–3 weeks, they received “alert messages”that were designed to help them gradually cut down to zero cigarettes by the end of the 4th week. Study staff explained that the purpose of the SGR program was to break the connection between cues and smoking. Staff explained that it works when women follow the schedule closely, smoking only when they receive alerts. Main Intervention strategy: Health Education (single) v alternative Intervention Intensity: Frequency (C = 6, I = 6) Duration (C = 4, I = 4). Technological intervention: unclear if efficacy or effectiveness.
Outcomes	Biochemically validated 7‐day point prevalence of smoking cessation at end of pregnancy*. Many outcomes were based around the feasibility, acceptability and efficacy of the intervention and study itself.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Study staff randomised women, stratified by number of cigarettes smoked and partner smoking status.
Allocation concealment (selection bias)	Unclear risk	Not reported.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Those who were lost to follow‐up were counted as smokers.
Selective reporting (reporting bias)	Low risk	As this is a pilot study, efficacy, validity and feasibility were all reported.
Other bias	Low risk	No other bias detected.
Biochemical validation of smoking abstinence (detection bias)	Low risk	Smoking was biochemically validated, saliva samples were analysed for the presence of cotinine using radioimmunoassay. A cut point of 10 ng/mL for saliva cotinine with pregnant women was used to discriminate abstainers and smokers.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Participants and personnel likely to have been aware of group allocation, although not explicitly stated.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Unclear as to whether the research staff were blinded to the outcome assessment.
Incomplete implementation	Low risk	Of the 31 women enrolled, 86% of women in both arms reported reading “all or most” of the support messages. Women in the SGR arm responded to 68% of alert texts within 60 min.
Equal baseline characteristics in study arms	Unclear risk	Women in the control arm were more likely to be partnered with a smoker. Women in the intervention arm were heavier smokers, were less likely to have reduced their smoking during the pregnancy, and were less likely to have attempted to quit.
Contamination of control group	Low risk	Intervention was provided directly to participants via their mobile phone, so low risk of contamination.