Postpartum Smoking Relapse Prevention by Breastfeeding Promotion

NCT ID: NCT04670822

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-31
• Study Completion Date: 2023-12-31

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.

Conditions

Smoking, Cigarette; Breastfeeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Breastfeeding intervention group

A multicomponent behavioral intervention to promote breastfeeding

Group Type: EXPERIMENTAL

Breastfeeding promotion

Intervention Type: BEHAVIORAL

The intervention group will receive multicomponent interventions consisting of 7 half-hour postnatal visits for lactation counseling, family/peer/employer support, contingent financial incentives, and early limited formula milk via syringe (optional for at-risk infants).

Attention placebo control group

General infant care counseling and support

Group Type: PLACEBO_COMPARATOR

Attention placebo control

Intervention Type: BEHAVIORAL

The attention placebo control group will complete the same frequency and duration of study visits as the intervention group but focus on general infant care counseling and support.

Interventions

Breastfeeding promotion

The intervention group will receive multicomponent interventions consisting of 7 half-hour postnatal visits for lactation counseling, family/peer/employer support, contingent financial incentives, and early limited formula milk via syringe (optional for at-risk infants).

Intervention Type: BEHAVIORAL

Attention placebo control

The attention placebo control group will complete the same frequency and duration of study visits as the intervention group but focus on general infant care counseling and support.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

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

NIH

Sponsor Role: collaborator

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Xiaozhong Wen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaozhong Wen

Role: PRINCIPAL_INVESTIGATOR

State University of New York at Buffalo

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R21HD091515

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MODCR00004712

Identifier Type: -

Identifier Source: org_study_id