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

NCT ID: NCT05123118

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-10-30

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.

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.

Conditions

Smoking, Cigarette; Breastfeeding

Study Design

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

Study Groups

Integrated intervention

Integrated intervention of smoking cessation and breastfeeding

Group Type: EXPERIMENTAL

Integrated intervention of smoking cessation and breastfeeding

Intervention Type: BEHAVIORAL

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

Attention placebo control group

Instructions on general pregnancy and infant care

Group Type: ACTIVE_COMPARATOR

Attention placebo control

Intervention Type: 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).

Interventions

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.

Intervention Type: 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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Xiaozhong Wen

OTHER

Sponsor Role: lead

Responsible Party

Xiaozhong Wen

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xiaozhong Wen, MD, PhD

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

UL1TR001412

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00003067

Identifier Type: -

Identifier Source: org_study_id