Postpartum Smoking Relapse Prevention by Breastfeeding Promotion

NCT04670822 | Completed Results

• 2 other identifiers: MODCR00004712R21HD091515
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking, Cigarette; Breastfeeding

Keywords

Postpartum; Relapse

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reporting to Breastfeed

  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.

  9 months postpartum

Study Arms (2)

Breastfeeding intervention group

EXPERIMENTAL

A multicomponent behavioral intervention to promote breastfeeding

Behavioral: Breastfeeding promotion

Attention placebo control group

PLACEBO COMPARATOR

General infant care counseling and support

Behavioral: Attention placebo control

Interventions

Breastfeeding promotion 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).

Breastfeeding intervention group

Attention placebo control 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.

Attention placebo control group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (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, 14214, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Breast Feeding; Recurrence

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Feeding Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Xiaozhong Wen
• Organization: State University of New York at Buffalo

xiaozhon@buffalo.edu

7168296811

Study Officials

• Xiaozhong Wen

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 17, 2020
• Study Start: July 31, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 15, 2025
• Results First Posted: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)