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

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.

Study Overview

• Status: Recruiting
• Conditions: Breastfeeding; Smoking ( Cigarette)
• Intervention / Treatment: Behavioral: Breastfeeding promotion; Behavioral: Attention placebo control

Detailed Description

We propose a randomized controlled trial to reduce postpartum smoking relapse by breastfeeding promotion from late pregnancy to 12 months postpartum. We will enroll 280 pregnant mothers who successfully quit smoking during this pregnancy (≤28 weeks). After the pre-test, participants who are still smoking abstinent will be randomized into either the breastfeeding intervention group (N=140) or the attention control group (N=140). The intervention group will receive a multicomponent intervention consisting of breastfeeding education, lactation counseling, social support, contingent financial incentives, and early limited formula milk via syringe feeding (optional for at-risk infants). The control group will receive counseling and support focusing on general infant care, with attention and monetary earnings similar to the intervention group. Both groups will receive usual care (i.e., information, education, and Quitline) for postpartum smoking relapse. The outcomes are postpartum smoking relapse, breastfeeding practices, and maternal and child health.

Aim 1 is to examine the efficacy of breastfeeding promotion intervention on postpartum smoking relapse. Aim 2 is to examine potential mediating mechanisms: reductions in stress and negative affect, enhancing mother-infant bonding and maternal sensitivity, and maternal weight retention. Aim 3 is to assess the effects of breastfeeding promotion intervention on maternal and infant health among ex-smoking mothers. This innovative study can yield promising data to support a new intervention to prevent postpartum smoking relapse. It has the potential to reduce smoking-related harms to both the mother and the infant, maximize the protective effects of breastfeeding on infant health and development, and narrow health disparities.

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaozhong Wen; Phone Number: 716-829-6811; Email: xiaozhon@buffalo.edu

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14214
      • Recruiting
      • Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo
      • Contact: Xiaozhong Wen; Phone Number: 716-829-6811; Email: xiaozhon@buffalo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Be pregnant
• Be 18 years or older
• Have quit smoking cigarettes during this pregnancy
• Be willing to receive infant care and breastfeeding education
• Be able to read, listen, and talk in English

Exclusion Criteria:

• Medical conditions contraindicating breastfeeding, such as HIV infection, active tuberculosis, and breast removal
• Current heavy drinking (≥4 standard drinks on any day or ≥8 standard drinks per week)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Attention placebo control group; General infant care counseling and support	Behavioral: Attention placebo control; The control group will receive instructions on general pregnancy and infant care from this project
Experimental: Breastfeeding intervention grou; A multicomponent behavioral intervention to promote breastfeeding	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants reporting to smoke	12 months postpartum

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants reporting to breastfeed	12months postpartum
Systolic blood pressure level	12 months postpartum
Diastolic blood pressure level	12 months postpartum
Infant weight-for-length z-score	12 months of age
Infant length-for-age z-score	12 months of age
Infant head circumference	12 months of age
Infant arm circumference	12 months of age
Number of infants with bronchiolitis	12 months of age

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Xiaozhong Wen, State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): July 31, 2031

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy; Postpartum; Relapse
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Behavior; Smoking; Feeding Behavior; Tobacco Smoking; Tobacco Use; Recurrence; Breast Feeding; Cigarette Smoking
• Other Study ID Numbers: STUDY00002632; R01HD117113 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No