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

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.

Study Overview

• Status: Completed
• Conditions: Breastfeeding; Smoking, Cigarette
• Intervention / Treatment: Behavioral: Integrated intervention of smoking cessation and breastfeeding; Behavioral: Attention placebo control

Detailed Description

The investigators are proposing the first randomized controlled trial to integrate maternal smoking cessation and breastfeeding interventions to enhance both cancer prevention behaviors. The investigators will recruit 40 daily smoking women in their 1st or 2nd trimester of pregnancy (≤28 weeks) from local obstetric clinics, communities, and social media. They will be randomized into either the intervention (N=20) or control group (N=20). The two groups will complete the same number of sessions (6 during pregnancy and 3 postpartum), but focus on different topics. Specifically, the control group will receive instructions on general pregnancy and infant care. The intervention group will receive instructions on general pregnancy and infant care, plus an integrated multicomponent intervention that promotes both smoking cessation and breastfeeding (i.e., education and counseling, monitoring and feedback, and contingent financial incentives). Two female Certified Lactation Counselors (interventionists) will be trained to run study sessions during home visits. Interventionists will provide additional support via phone and text messaging until 6 months postpartum. Main outcomes include smoking abstinence and breastfeeding rates at 6 months postpartum within the duration of this award.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

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 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

Exclusion Criteria:

• 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

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: Integrated intervention; Integrated intervention of smoking cessation and breastfeeding	Behavioral: Integrated intervention of smoking cessation and breastfeeding; The intervention group will receive an integrated intervention of smoking cessation and breastfeeding: education and counseling, monitoring and feedback, and contingent financial incentives.
Active Comparator: Attention placebo control group; Instructions on general pregnancy and infant care	Behavioral: Attention placebo control; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).60,61 The self-reported smoking abstinence will be biochemically confirmed by urine cotinine tests (<50 ng/mL).	6 months postpartum
Breastfeeding intention	During pregnancy, participants will report breastfeeding intention using questionnaires modified from the Infant Feeding Practices Study II.	35 weeks of pregnancy (the end of pregnancy)
Breastfeeding status	During postpartum, mothers will report breastfeeding status (exclusive, mixed with formula, non-breastfeeding) every month until 6 months postpartum.	6 months postpartum
Breastfeeding frequency	During postpartum, mothers will report breastfeeding frequency (times per day) every month until 6 months postpartum.	6 months postpartum
Breastfeeding duration	During postpartum, mothers will update breastfeeding duration (weeks) every month until 6 months postpartum.	6 months postpartum
Formula duration	During postpartum, mothers will update formula duration (weeks) every month until 6 months postpartum.	6 months postpartum

Collaborators and Investigators

• Sponsor: Xiaozhong Wen
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Xiaozhong Wen, MD, PhD, State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: November 4, 2021
• First Posted (Actual): November 17, 2021

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Pregnancy; Postpartum; Smoking abstinence; Breastfeeding duration; Breastfeeding intention
• Other Study ID Numbers: STUDY00003067; UL1TR001412 (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