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

NCT04985903 | Active Not Recruiting

• 1 other identifier: Pro00106131
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Smoking Cessation; Pregnancy; Communication Research

Keywords

Pregnant smokers

Outcome Measures

Primary Outcomes (1)

• 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.

  End-of-pregnancy, up to 45 minutes

Secondary Outcomes (2)

• Number of A's performed in the Post-Intervention Phase for each Clinician

  Post-intervention recordings (all recording will happen prior to giving birth), up to 12 weeks

• Mean rated autonomy support for each Post-intervention patient

  Baseline, up to 15 minutes

Study Arms (2)

Intervention

EXPERIMENTAL

Clinicians in the intervention arm will receive a tailored communication training on smoking cessation skills and a general lecture on smoking cessation.

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.

Other: 5A's lecture

Interventions

Clinician Communication Intervention BEHAVIORAL

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.

Intervention

5A's lecture OTHER

a lecture on general information about smoking cessation for pregnant patients and smoking cessation counseling.

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• Unable to speak and read English

Sponsors & Collaborators

• Duke University: lead
• University of Pittsburgh: collaborator

Study Sites (1)

Durham OB

Durham, North Carolina, 27704, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Kathryn I Pollak, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: We will mask the intervention arms during the coding process.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 2, 2021
• Study Start: March 25, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)