BABY STEPS II: SMS Scheduled Gradual Reduction Text Messages to Help Pregnant Smokers Quit

Background and Significance:

Smoking during pregnancy is associated with a plethora of negative effects on the fetus,
including preterm birth, low birth weight, fetal growth restriction, placental abruption,
fetal/neonatal death, sudden infant death syndrome, learning disabilities and attention
deficit disorder. Quitting smoking improves the health of the fetus, and if the cessation is
maintained, the health of the mother and other family members living in the household. Yet
despite the commonly known evidence of the harms, as much as half of women who smoke continue
to do so when becoming pregnant.

Cognitive-behavioral cessation interventions for pregnant smokers have had modest success
with quit rates that range from 10 to 30%. Interventions have included face-to-face
counseling or telephone counseling, neither of which is easily disseminable in the health
care setting. Using SMS (Short Message Service) text messaging to deliver counseling has the
potential for efficacy and widespread dissemination. The only trial that used text messaging
to target cessation during pregnancy found null results. Thus, a counseling intervention via
SMS texting might not be potent enough to promote cessation; pregnant smokers might need more
assistance. Scheduled gradual reduction (SGR) might be an effective strategy to supplement
counseling. SGR first assesses smokers' patterns, then over the course of three or four
weeks, gradually reduces the number of cigarettes smoked by lengthening the time interval
between cigarettes. Thus, smokers might be prompted to smoke at a time when they do not want
to smoke and might not be prompted to smoke at a time when they want to smoke. The smoking
becomes unlinked from the cues (psychological and behavioral), and smokers must work through
their times of craving (physiological). Therefore, when cigarettes get fewer and fewer in the
last two weeks, smokers should have an easier time giving them up completely.

Knowing whether an SMS text-messaging intervention plus a SMS text-based counseling
intervention helps pregnant smokers quit could significantly improve the maternal and fetal
health of any pregnant woman with a cell phone with texting ability. Most previous
efficacious interventions that have helped pregnant smokers quit are not easily disseminated.
A texting intervention could impact many pregnant women's health given the reach and
disseminability.

Design:

The two-arm randomized controlled trial compares Arm 1, SGR via SMS text messaging plus SMS
Support Messages to Arm 2, SMS Support Messages alone. The study team will conduct three
face-to-face surveys, one at baseline (between 10 and 28 weeks of pregnancy), one in the late
third trimester, and another at 3 months postpartum. The study team will biochemically
validate smoking abstinence and reduction via saliva. Women randomized to Arm 1 will start to
receive SGR messages one week after they enroll. They will receive these messages for 3-5
weeks depending on the amount of cigarettes they smoke at time of enrollment. Women
randomized to both arms will receive Support messages from the time of enrollment through 35
weeks gestation.

Inclusion Criteria:

Women who:

- are between 10 and 28 weeks pregnant,

- have smoked at least 100 cigarettes in their lifetime,

- smoke 3 or more cigarettes per day in the prior 7 days,

- are current smokers,

- are willing to try to quit smoking,

- are enrolled in prenatal care at the clinics from which the study team is recruiting
and plan to receive care there throughout their pregnancy,

- are age 18 or older,

- speak English

Exclusion Criteria:

- evidence of unstable cognitive or mental health problems who cannot properly provide
consent.