Smoking CessationNCT04985903
Baby Steps III: Testing a Clinician and Patient Intervention to Promote Smoking Cessation Among Pregnant Women
A study testing Clinician Communication Intervention and 5A's lecture in people with Smoking Cessation and Pregnancy, run by Duke University at 1 site in United States.
Trial summary
The investigators propose to conduct a combined intervention that pairs SMS smoking cessation messages for patients with individualized training for OB clinicians to improve quit rates among pregnant smoking. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Pregnancy, Communication Research
- What is being tested?
- Clinician Communication Intervention and 5A's lecture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2022to 8 May 2026
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years old
- Receiving prenatal care from an enrolled OB clinician
- Self-report smoking tobacco at their first OB visit
- Access to a cell phone with texting capabilities
Who cannot join
- Unable to speak and read English
Trial locations and contacts
1 site in 1 country.
About this study
The investigators propose to conduct a combined intervention that pairs SMS smoking cessation messages for patients with individualized training for OB clinicians to improve quit rates among pregnant smoking. The aim is to determine the effect of the intervention versus control on smoking cessation outcomes on patient smoking cessation. The investigators will recruit patients at their first OB visit who report smoking at Duke and Pitt. Patients in both the control and intervention arm will receive smoking cessation support messages throughout their pregnancy. OB clinicians in the intervention arm will receive tailored smoking cessation counseling training. Clinicians in both arms will receive a one-time 5 A lecture. The investigators will analyze smoking cessation outcomes and audio recordings. This is a minimal risk study.
Read the detailed description
The investigators propose a two-arm cluster randomized controlled design, in which the unit of randomization is the OB clinician. 70 OB clinicians will be randomly assigned to either the intervention or control condition. Although the unit of randomization is the clinician, the unit of evaluation is the patient: range of 6-13 patients per clinician (1-3 Pre-intervention and 5-10 Post-intervention) who receive prenatal care from enrolled OB clinicians at Duke and UPitt. The investigators will collect 3 Pre-Intervention audio-recorded initial OB visit encounters to assess pre-intervention levels of clinician communication skills and also to tailor the clinician training program. After the Pre-Intervention Phase, the investigators will randomize OB clinicians to either the intervention or control arm (see details of cluster randomization below). All OB clinicians will attend a lecture about the consequences of smoking during pregnancy and the elements of the 5 A's. Only OB clinicians randomized to the intervention arm will receive an individually-tailored, user-friendly, web-based program that teaches the 5 A's. In the Post-Intervention Phase, the investigators will assess the effect of the communication program by audio recording initial OB visits for between 5-10 pregnant women who smoke for each OB clinician in both arms (n=542 total). The investigators will provide all patients the SMS text-delivered intervention. Additionally, the investigators will survey these patients before their visit, immediately after their visit, at the end-of-pregnancy, and 6-weeks postpartum. Due to anticipated study attrition, the investigators will recruit up 80 clinicians and 700 patients at both sites until the investigators reach a complete data set for our desired sample size. Biochemically validated smoking cessation at end-of-pregnancy is the primary outcome (Aim 1). To assess Aim 2, investigators will code for clinician use of the 5 A's in the audio-recorded encounters and analyze patient perceptions of the communication from post-encounter data and the post-study survey for clinicians. To assess Aim 3, investigators will collect smoking status at 6 weeks postpartum.
- Conditions
- Smoking Cessation, Pregnancy, Communication Research
- Being tested
- Clinician Communication Intervention, 5A's lecture
- Keywords
- Pregnant smokers
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinician Communication InterventionBehavioural
The focus of the communication program is to help clinicians increase their use of the 5 A's by improving knowledge, self-efficacy, outcome expectations, and communication skills. Training modules include didactic information with video clips of sample conversations showing specific communication skills, feedback on clinician's usage of the 5A's, and audio clips from their Pre-Intervention recorded conversations.
5A's lectureOther
a lecture on general information about smoking cessation for pregnant patients and smoking cessation counseling.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Clinicians in the intervention arm will receive a tailored communication training on smoking cessation skills and a general lecture on smoking cessation. Receives: Behavioral: Clinician Communication Intervention; Other: 5A's lecture |
| Control | Active comparator | Clinicians in the control arm will be asked to attend a lecture on general information about smoking cessation for pregnant patients and smoking cessation counseling. Receives: Other: 5A's lecture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients in the Post-Intervention Phase With Validated Cessation
Biochemically validated (urine cotinine) 7-day point prevalent as defined by urine cotinine levels below 50ng/ML.
Measured: End-of-pregnancy, up to 45 minutes
Secondary outcomes (2)
Number of A's performed in the Post-Intervention Phase for each Clinician
Obtained by coding 11 recordings of patient encounters in the Post-Intervention Phase. We will follow a codebook to assess the number of A's performed in the Post-Intervention visits for each clinician. Coders will also assess whether each Advice segment is clear, strong, or personalized. We will assign advice a score of 0-3 with a score of 3 indicating highest quality of advice.
Measured: Post-intervention recordings (all recording will happen prior to giving birth), up to 12 weeks
Mean rated autonomy support for each Post-intervention patient
6-item Health care climate questionnaire
Measured: Baseline, up to 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start25 Mar 2022
- Primary completion8 May 2026
- Study completion8 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh
- Responsible party
- Sponsor
- Investigators
- Kathryn I Pollak, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985903
- Sponsor's protocol ID
- Pro00106131
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2021
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baby Steps III: Testing a Clinician and Patient Intervention to Promote Smoking Cessation Among Pregnant Women
- ClinicalTrials.gov ID
- NCT04985903
- Acronym / sponsor ID
- Pro00106131
- Conditions
- Smoking Cessation, Pregnancy, Communication Research
- Keywords
- Pregnant smokers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of Pittsburgh
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 8 May 2026 (actual)
- Study completion
- 8 May 2026 (actual)
- First posted
- 2 Aug 2021 (actual)
- 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.
The investigators propose to conduct a combined intervention that pairs SMS smoking cessation messages for patients with individualized training for OB clinicians to improve quit rates among pregnant smoking. The aim is to determine the effect of the intervention versus control on smoking cessation outcomes on patient smoking cessation. The investigators will recruit patients at their first OB visit who report smoking at Duke and Pitt. Patients in both the control and intervention arm will receive smoking cessation support messages throughout their pregnancy. OB clinicians in the intervention arm will receive tailored smoking cessation counseling training. Clinicians in both arms will receive a one-time 5 A lecture. The investigators will analyze smoking cessation outcomes and audio recordings. This is a minimal risk study.
Detailed description
The investigators propose a two-arm cluster randomized controlled design, in which the unit of randomization is the OB clinician. 70 OB clinicians will be randomly assigned to either the intervention or control condition. Although the unit of randomization is the clinician, the unit of evaluation is the patient: range of 6-13 patients per clinician (1-3 Pre-intervention and 5-10 Post-intervention) who receive prenatal care from enrolled OB clinicians at Duke and UPitt. The investigators will collect 3 Pre-Intervention audio-recorded initial OB visit encounters to assess pre-intervention levels of clinician communication skills and also to tailor the clinician training program. After the Pre-Intervention Phase, the investigators will randomize OB clinicians to either the intervention or control arm (see details of cluster randomization below). All OB clinicians will attend a lecture about the consequences of smoking during pregnancy and the elements of the 5 A's. Only OB clinicians randomized to the intervention arm will receive an individually-tailored, user-friendly, web-based program that teaches the 5 A's. In the Post-Intervention Phase, the investigators will assess the effect of the communication program by audio recording initial OB visits for between 5-10 pregnant women who smoke for each OB clinician in both arms (n=542 total). The investigators will provide all patients the SMS text-delivered intervention. Additionally, the investigators will survey these patients before their visit, immediately after their visit, at the end-of-pregnancy, and 6-weeks postpartum. Due to anticipated study attrition, the investigators will recruit up 80 clinicians and 700 patients at both sites until the investigators reach a complete data set for our desired sample size. Biochemically validated smoking cessation at end-of-pregnancy is the primary outcome (Aim 1). To assess Aim 2, investigators will code for clinician use of the 5 A's in the audio-recorded encounters and analyze patient perceptions of the communication from post-encounter data and the post-study survey for clinicians. To assess Aim 3, investigators will collect smoking status at 6 weeks postpartum.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Clinician Communication Intervention, Other: 5A's lectureClinicians in the intervention arm will receive a tailored communication training on smoking cessation skills and a general lecture on smoking cessation. |
| Control | Active comparator | Other: 5A's lectureClinicians in the control arm will be asked to attend a lecture on general information about smoking cessation for pregnant patients and smoking cessation counseling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years old
- Receiving prenatal care from an enrolled OB clinician
- Self-report smoking tobacco at their first OB visit
- Access to a cell phone with texting capabilities
Key exclusion criteria (1 listed)
- Unable to speak and read English
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 |
|---|---|---|
| Clinician Communication InterventionThe focus of the communication program is to help clinicians increase their use of the 5 A's by improving knowledge, self-efficacy, outcome expectations, and communication skills. Training modules include didactic information with video clips of sample conversations showing specific communication skills, feedback on clinician's usage of the 5A's, and audio clips from their Pre-Intervention recorded conversations. | Behavioural | Intervention |
| 5A's lecturea lecture on general information about smoking cessation for pregnant patients and smoking cessation counseling. | Other | Control, Intervention |
Primary outcome
Number of Patients in the Post-Intervention Phase With Validated Cessation
Time frame: End-of-pregnancy, up to 45 minutes
Biochemically validated (urine cotinine) 7-day point prevalent as defined by urine cotinine levels below 50ng/ML.
2 secondary outcomes
Number of A's performed in the Post-Intervention Phase for each Clinician
Time frame: Post-intervention recordings (all recording will happen prior to giving birth), up to 12 weeks
Mean rated autonomy support for each Post-intervention patient
Time frame: Baseline, up to 15 minutes
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 15 Oct 2026.
- Individual participant dataSharing planned: No
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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 I 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 Clinician Communication Intervention and 5A's lecture in people with Smoking Cessation 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 4 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 15 Oct 2026. 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?
Number of Patients in the Post-Intervention Phase With Validated Cessation (time frame: End-of-pregnancy, up to 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.