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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Duke University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01995097
First received: November 20, 2013
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Smoking
Pregnancy
Behavioral: Scheduled Gradual Reduction Text Messages
Behavioral: Support Text Messages

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: SMS Scheduled Gradual Reduction Text Messages to Help Pregnant Smokers Quit

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • biochemically validated seven-day point prevalence smoking abstinence [ Time Frame: late third trimester (35 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • prolonged smoking abstinence [ Time Frame: late third trimester (35 weeks gestation) ] [ Designated as safety issue: No ]
  • biochemically validated smoking reduction [ Time Frame: late third trimester (35 weeks gestation) ] [ Designated as safety issue: No ]
  • biochemically validated postpartum smoking abstinence [ Time Frame: 3 months postpartum ] [ Designated as safety issue: No ]
  • preterm birth [ Time Frame: delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 522
Study Start Date: March 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01995097

Contacts
Contact: Alicia Bilheimer, MPH 919-681-4558 alicia.bilheimer@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Alicia Bilheimer, MPH    919-681-4558    alicia.bilheimer@duke.edu   
Principal Investigator: Kathryn Pollak, PhD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Kathryn Pollak, PhD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01995097     History of Changes
Other Study ID Numbers: Pro00044933, R01CA166149
Study First Received: November 20, 2013
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
smoking cessation
smoking reduction
scheduled gradual reduction
pregnancy
text message intervention

ClinicalTrials.gov processed this record on September 18, 2014