Postpartum Smoking Relapse Prevention by Breastfeeding Promotion

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.

Study Overview

• Status: Completed
• Conditions: Breastfeeding; Smoking, Cigarette
• Intervention / Treatment: Behavioral: Breastfeeding promotion; Behavioral: Attention placebo control

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaozhong Wen; Phone Number: 17168296811; Email: xiaozhon@buffalo.edu

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14214
      • Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 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
Experimental: Breastfeeding intervention group; A multicomponent behavioral intervention to promote breastfeeding	Behavioral: 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).
Placebo Comparator: Attention placebo control group; General infant care counseling and support	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of smoking relapse	The date of postpartum relapse will be defined as the first day after delivery on which an ex-smoker has smoked for 7 consecutive days. Reported smoking abstinence will be verified by urine cotinine test.	6 months postpartum (post-test)
Rates of smoking relapse	The date of postpartum relapse will be defined as the first day after delivery on which an ex-smoker has smoked for 7 consecutive days. Reported smoking abstinence will be verified by urine cotinine test.	9 months postpartum (follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breastfeeding duration	Postpartum mothers will report their current feeding method, frequency, and duration of breastfeeding and/or formula use. Breastfeeding status will be visually verified by a female research staff, looking for one of the following indicators of successful breastfeeding in the infant - audible swallowing, a regular suck/swallow/breath pattern, or visible milk in the infant's mouth after they are not latched anymore.	Up to 9 months postpartum

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2018
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Postpartum; Relapse
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: MODCR00004712; R21HD091515 (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