ClinicalTrials.gg
CompletedNCT01995097Updated Feb 8, 2019

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

An interventional study of Scheduled Gradual Reduction Text Messages and Support Text Messages in Smoking and Pregnancy, sponsored by Duke University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-08.

Sponsored by Duke University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
331
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

Primary Aim: To test the efficacy of a SMS text-based scheduled gradual reduction (SGR) and counseling intervention to promote smoking cessation in the late third trimester.

Hypothesis: The rate of smoking cessation in the late third trimester among women in the SGR Support Messages arm will be higher than among women in the Support Messages arm.

Secondary Aim 1: To assess the effect of the SGR intervention on biochemically validated prolonged abstinence and smoking reduction during pregnancy.

Secondary Aim 2: To assess the effect of the SGR intervention on smoking abstinence at three months postpartum.

Secondary Aim 3: To assess the effect of the SGR intervention on the rate of preterm birth.

Read the detailed description

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.

02

Conditions studied

  • Smoking
  • Pregnancy

Keywords

  • smoking cessation
  • smoking reduction
  • scheduled gradual reduction
  • pregnancy
  • text message intervention
03

In context

Smoking

325 studies on the registry are indexed under Smoking; 141 are open to participants now.

This study's enrollment of 331 is above the median of 117 across 250 interventional studies indexed under Smoking.

Browse Smoking studies →

Lead sponsor

Duke University is the lead sponsor of 2,058 studies on the registry; 274 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 165 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
331 participants (actual)

Study arms

  • Experimental
    SGR + Support Messages

    scheduled gradual reduction text messages for first 3-5 weeks of participation; support text messages through 35th week of pregnancy

    Behavioral: Scheduled Gradual Reduction Text Messages · Behavioral: Support Text Messages

  • Active comparator
    Support Messages Only

    support text messages through 35th week of pregnancy

    Behavioral: Support Text Messages

Interventions

  • BehavioralScheduled Gradual Reduction Text Messages
  • BehavioralSupport Text Messages
06

What researchers measure

Primary outcomes

  1. biochemically validated seven-day point prevalence smoking abstinence

    Time frame: late third trimester (35 weeks)

Secondary outcomes

  1. prolonged smoking abstinence

    Time frame: late third trimester (35 weeks gestation)

  2. biochemically validated smoking reduction

    Time frame: late third trimester (35 weeks gestation)

  3. biochemically validated postpartum smoking abstinence

    Time frame: 3 months postpartum

  4. preterm birth

    Time frame: delivery

07

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27705, United States
08

References and documents

Publications

  • Kennedy DL, Lyna P, Gao X, Noonan D, Bejarano Hernandez S, Fish LJ, Swamy GK, Pollak KI. Effects of Smoking Reduction and Cessation on Birth Outcomes in a Scheduled Gradual Reduction Cessation Trial. Matern Child Health J. 2022 May;26(5):963-969. doi: 10.1007/s10995-022-03386-6. Epub 2022 Mar 2. PubMed 35235142 ↗
  • Noonan D, Lyna P, Kennedy DL, Gao X, Bejarano Hernandez S, Fish LJ, Pollak KI. Trajectories of Situational Temptations in Pregnant Smokers participating in a Scheduled Gradual Reduction Cessation Trial. Matern Child Health J. 2022 Jan;26(1):24-30. doi: 10.1007/s10995-021-03321-1. Epub 2021 Dec 3. PubMed 34860350 ↗
  • Pollak KI, Lyna P, Gao X, Noonan D, Hernandez SB, Subudhi S, Kennedy D, Farrell D, Swamy GK, Fish LJ. Pilot Test of Connecting Pregnant Women who Smoke to Short Message Service (SMS) Support Texts for Cessation. Matern Child Health J. 2020 Apr;24(4):419-422. doi: 10.1007/s10995-020-02893-8. PubMed 32026323 ↗
  • Pollak KI, Lyna P, Gao X, Noonan D, Bejarano Hernandez S, Subudhi S, Swamy GK, Fish LJ. Efficacy of a Texting Program to Promote Cessation Among Pregnant Smokers: A Randomized Control Trial. Nicotine Tob Res. 2020 Jun 12;22(7):1187-1194. doi: 10.1093/ntr/ntz174. PubMed 31647564 ↗

Study documents

  • Protocol and informed consent form · Mar 24, 2017

Documents are hosted by the registry — open the source record to download them.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2014, a primary completion of Dec 2017 and a completion of Feb 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 20, 2013
First posted
Nov 26, 2013
Start
Mar 2014
Primary completionActual
Dec 13, 2017
CompletionActual
Feb 20, 2018
Last update
Feb 8, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01995097
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Nov 26, 2013
Start date
Mar 2014
Primary completion
Dec 13, 2017
Completion
Feb 20, 2018
Last update
Feb 8, 2019

Study contacts

Kathryn Pollak, PhD
principal investigator · Duke University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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