SmokingNCT01995097
BABY STEPS II: SMS Scheduled Gradual Reduction Text Messages to Help Pregnant Smokers Quit
A study testing Scheduled Gradual Reduction Text Messages and Support Text Messages in people with Smoking and Pregnancy, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Scheduled Gradual Reduction Text Messages and Support Text Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 20 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- 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
Who cannot join
- evidence of unstable cognitive or mental health problems who cannot properly provide consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: SMS Scheduled Gradual Reduction Text Messages to Help Pregnant Smokers Quit
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.
- Being tested
- Scheduled Gradual Reduction Text Messages, Support Text Messages
- Keywords
- smoking cessation, smoking reduction, scheduled gradual reduction, pregnancy, text message intervention
- Medical subject headings
- Smoking, Smoking Cessation, Smoking Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scheduled Gradual Reduction Text MessagesBehavioural
Support Text MessagesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| SGR + Support Messages | Experimental | scheduled gradual reduction text messages for first 3-5 weeks of participation; support text messages through 35th week of pregnancy Receives: Behavioral: Scheduled Gradual Reduction Text Messages; Behavioral: Support Text Messages |
| Support Messages Only | Active comparator | support text messages through 35th week of pregnancy Receives: Behavioral: Support Text Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
biochemically validated seven-day point prevalence smoking abstinence
Measured: late third trimester (35 weeks)
Secondary outcomes (4)
prolonged smoking abstinence
Measured: late third trimester (35 weeks gestation)
biochemically validated smoking reduction
Measured: late third trimester (35 weeks gestation)
biochemically validated postpartum smoking abstinence
Measured: 3 months postpartum
preterm birth
Measured: delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startMar 2014
- Primary completion13 Dec 2017
- Study completion20 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathryn Pollak, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995097
- Sponsor's protocol ID
- Pro00044933
- Other IDs
- R01CA166149
- Status last verified
- Dec 2017
- First submitted
- 20 Nov 2013
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
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 35235142Noonan 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 34860350Pollak 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 32026323Pollak 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 at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMS Scheduled Gradual Reduction Text Messages to Help Pregnant Smokers Quit
- ClinicalTrials.gov ID
- NCT01995097
- Acronym / sponsor ID
- Pro00044933
- Keywords
- smoking cessation, smoking reduction, scheduled gradual reduction, pregnancy, text message intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2014
- Primary completion
- 13 Dec 2017 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 26 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGR + Support Messages | Experimental | Behavioral: Scheduled Gradual Reduction Text Messages, Behavioral: Support Text Messagesscheduled gradual reduction text messages for first 3-5 weeks of participation; support text messages through 35th week of pregnancy |
| Support Messages Only | Active comparator | Behavioral: Support Text Messagessupport text messages through 35th week of pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (1 listed)
- evidence of unstable cognitive or mental health problems who cannot properly provide consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scheduled Gradual Reduction Text Messages | Behavioural | SGR + Support Messages |
| Support Text Messages | Behavioural | SGR + Support Messages, Support Messages Only |
Primary outcome
biochemically validated seven-day point prevalence smoking abstinence
Time frame: late third trimester (35 weeks)
4 secondary outcomes
prolonged smoking abstinence
Time frame: late third trimester (35 weeks gestation)
biochemically validated smoking reduction
Time frame: late third trimester (35 weeks gestation)
biochemically validated postpartum smoking abstinence
Time frame: 3 months postpartum
preterm birth
Time frame: delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Derived from this study: PubMed 35235142Kennedy 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.
- Derived from this study: PubMed 34860350Noonan 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.
- Derived from this study: PubMed 32026323Pollak 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.
- Derived from this study: PubMed 31647564Pollak 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Pollak, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scheduled Gradual Reduction Text Messages and Support Text Messages in people with Smoking and Pregnancy, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biochemically validated seven-day point prevalence smoking abstinence (time frame: late third trimester (35 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01995097, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.