Postpartum Smoking Relapse Prevention by Breastfeeding Promotion

Not Applicable

Completed

• Conditions: Breastfeeding; Smoking, Cigarette
• Interventions: Behavioral: Breastfeeding promotion; Behavioral: Attention placebo control

• Registration Number: NCT04670822
• Lead Sponsor: State University of New York at Buffalo

Brief Summary

This is a randomized controlled trial to prevent postpartum smoking relapse by breastfeeding promotion. The intervention group (N=30) will receive multicomponent breastfeeding intervention from late pregnancy to 6 months postpartum, while the attention placebo control group (N=30) will receive general infant care counseling and support. The key outcome is the rate of postpartum smoking relapse.

Detailed Description

The investigators propose the first randomized controlled trial to reduce postpartum smoking relapse by breastfeeding promotion from late pregnancy to 6 months postpartum. The investigators will enroll 60 pregnant women who successfully quit smoking within 3 months before or during this pregnancy (\<28 weeks). All participants will receive breastfeeding education during late pregnancy. Right after delivery, participants who are still smoking abstinent will be randomized into either the breastfeeding intervention group (N=30) or the attention placebo control group (N=30). The intervention group will receive multicomponent interventions consisting of postnatal lactation counseling, family/peer/employer support, contingent financial incentives, and early limited formula milk via syringe (optional for at-risk infants). The control group will receive counseling and support focusing on general infant care with attention and compensation similar to the intervention group. The primary outcomes are rates of postpartum smoking relapse verified by urine cotinine test.

Specific Aim 1 is to examine the efficacy of breastfeeding promotion intervention on postpartum smoking relapse. Specific Aim 2 is to collect preliminary data regarding potential mediating mechanisms: increases in lactation hormones (plasma oxytocin and prolactin), reductions in stress and negative affect, and enhancing mother-infant bonding and maternal motivation to protect the infant from secondhand smoke exposure. This innovative and feasible pilot study can yield promising preliminary data to strongly support our future application of a NIH R01 grant proposal that has the potential to reduce smoking-related harms to both the mother and the infant, and maximize the protective effects of breastfeeding on infant health and development.

Study Timeline

• Study Start: 2018-07-31
• Study First Submitted: 2020-12-10
• Study First Submitted QC: 2020-12-10
• Study First Posted: 2020-12-17
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Results First Submitted: 2025-04-28
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Results First Posted: 2025-05-15
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Be pregnant or in the first 1 month postpartum
• Be 18 years or older
• Have quit smoking cigarettes during or before 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 (more than 2 drinks a day)
• Current use of illicit substances
• Being strongly against breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breastfeeding intervention group	Breastfeeding promotion	A multicomponent behavioral intervention to promote breastfeeding
Attention placebo control group	Attention placebo control	General infant care counseling and support

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting to Breastfeed	9 months postpartum	During postpartum, mothers report their breastfeeding status (exclusive, mixed with formula, non-breastfeeding) every month until 9 months postpartum. Any breastfeeding is defined as exclusive breastfeeding or mixed-feeding breast milk and formula.

Trial Locations

Locations (1)

Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo; 🇺🇸 Buffalo, New York, United States