Lung and Breast Cancer Prevention by an Integrated Intervention of Maternal Smoking Cessation and Breastfeeding

NCT05123118 | Completed Results

• 2 other identifiers: STUDY00003067UL1TR001412
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial aims to integrate maternal smoking cessation and breastfeeding interventions to enhance both cancer prevention behaviors. The investigators will recruit 40 daily smoking women in their early pregnancy and randomize them into the integrated intervention or control group. Main outcomes include smoking abstinence and breastfeeding rates at 6 months postpartum.

Conditions

Smoking, Cigarette; Breastfeeding

Keywords

Pregnancy; Postpartum; Smoking abstinence; Breastfeeding intention; Breastfeeding duration

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Smoking Abstinence

  Based on their recorded daily numbers of cigarettes and cigars smoked after enrollment, the investigators will classify smoking abstinence status in the past 7 days (7-day point-prevalence). The self-reported smoking abstinence will be biochemically confirmed by urine cotinine tests (\<50 ng/mL).

  6 months postpartum

• Number of Participants With Reported Intent to Breastfeed

  During pregnancy, participants will report breastfeeding intention using questionnaires modified from the Infant Feeding Practices Study II. The question is, "What method do you plan to use to feed your new baby in the first few weeks?" with 4 response options: 1) breastfeeding only (baby will not be given formula), 2) formula feed only, 3) both breastfeed and formula feed, or 4) unsure. We create a binary variable to indicate breastfeeding intentions (option 1 or 3) or other feeding intentions (option 2 or 4).

  35 weeks of pregnancy (the end of pregnancy)

• Number of Participants Reporting to Breastfeed

  During postpartum, mothers report their breastfeeding status (exclusive, mixed with formula, non-breastfeeding) every month until 6 months postpartum. Any breastfeeding is defined as exclusive breastfeeding or mixed-feeding breast milk and formula.

  6 months postpartum

Study Arms (2)

Integrated intervention

EXPERIMENTAL

Integrated intervention of smoking cessation and breastfeeding

Behavioral: Integrated intervention of smoking cessation and breastfeeding

Attention placebo control group

ACTIVE COMPARATOR

Instructions on general pregnancy and infant care

Behavioral: Attention placebo control

Interventions

Integrated intervention of smoking cessation and breastfeeding BEHAVIORAL

The intervention group will receive an integrated intervention of smoking cessation and breastfeeding: education and counseling, monitoring and feedback, and contingent financial incentives.

Integrated intervention

Attention placebo control BEHAVIORAL

Participants in the control group will receive usual prenatal care from physicians, nurses, or social workers. They will receive best standard care on smoking cessation and breastfeeding, including referral to the New York State Smokers' Quitline and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).

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 18 years or older
• At ≤28 weeks of pregnancy
• Daily smoking cigarettes and/or cigars in the past 7 days
• Be able to read, listen, and talk in English

You may not qualify if:

• Being diagnosed with cancer
• Current heavy drinking (more than 2 drinks a day)
• Current use of illicit substances
• Medical conditions contraindicating breastfeeding such as HIV infection, active tuberculosis, and breast removal

Sponsors & Collaborators

• Xiaozhong Wen: lead
• National Center for Advancing Translational Sciences (NCATS): 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

Interventions

Lactation

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Feeding Behavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Results Point of Contact

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

xiaozhon@buffalo.edu

7168296811

Study Officials

• Xiaozhong Wen, MD, PhD

  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
• Masking Details: Research staff who collect and analyze outcome data will be blinded to participants' group assignments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: The 40 eligible participants will be randomized into either the intervention (N=20) or control group (N=20). A sequence of random numbers in blocks of 2 will be used to ensure equal numbers of participants for each group over time.

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 17, 2021
• Study Start: January 1, 2021
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: April 17, 2025
• Results First Posted: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)