Baby Steps III: Testing a Clinician and Patient Intervention to Promote Smoking Cessation Among Pregnant Women

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Trial completed Show 5 more changesShow less
    • Final enrollment: 414 participants (planned 840)
    • Study completion date changed from estimate of Jul 15, 2026 to May 8, 2026
    • Interventions: 5A's lecture (Other), Clinician Communication Intervention (Behavioral) to 5A's lecture (Other), Clinician Communication Intervention (Behavioral)
    • Secondary endpoints: details revised at 1 of 2 entries
    • Eligibility criteria expanded, about 5 words
  2. Study completion pushed from May 31, 2026 to Jul 15, 2026
    • Primary completion date changed from estimate of May 31, 2026 to May 8, 2026
    v14
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Feb 27, 2026 to May 31, 2026
    • Site details revised
    v13
  4. Primary and study completion dates: Aug 1, 2025 to Feb 27, 2026v12
  5. Primary and study completion dates: Jun 1, 2025 to Aug 1, 2025v11
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  1. 2 versions Re-verified since May 22, 2024, no change to tracked fieldsv9-v10
  2. Study description expanded, about 3 wordsv8
  3. Enrollment target: 800 to 840
    • Study description revised
    v7
  4. Re-verified, no change to tracked fieldsv6
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of May 1, 2022 to Mar 25, 2022
    v5
  6. Start date: Feb 1, 2022 to May 1, 2022v4
  7. Start date: Jan 1, 2022 to Feb 1, 2022v3
  8. Eligibility criteria shortened, about 24 wordsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Duke University
457 trials monitored
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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.
Trial Details
NCT Number NCT04985903
Lead Sponsor Duke University
Collaborators: University of Pittsburgh
Conditions
(from sponsor)		 Smoking Cessation, Pregnancy, Communication Research
Related terms Smoking Cessation
Enrollment 414 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov