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Prevention of Postpartum Smoking Relapse and Related Health Consequences by Breastfeeding Promotion

NCT07661550 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2026-06-22

No results posted yet for this study

Summary

The objective of this randomized controlled trial is to examine the efficacy of a new intervention to prevent postpartum smoking relapse and related health consequences through breastfeeding promotion. After the pre-test, ex-smokers who are still abstinent from smoking will be randomized into either the breastfeeding intervention or the attention placebo control group. The outcomes are postpartum smoking relapse, breastfeeding practices, and maternal and child health.

Conditions

  • Smoking ( Cigarette)
  • Breastfeeding

Interventions

BEHAVIORAL

Breastfeeding promotion

The intervention group will receive a multicomponent intervention promoting breastfeeding, including education, lactation counseling, social support, breastfeeding-contingent financial incentives, and early limited formula milk via syringe feeding (optional for at-risk infants).

BEHAVIORAL

Attention placebo control

The control group will receive instructions on general pregnancy and infant care from this project

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • State University of New York at Buffalo

    lead OTHER

Principal Investigators

  • Xiaozhong Wen · State University of New York at Buffalo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2030-07-31
Completion
2031-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07661550 on ClinicalTrials.gov