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

Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05123118
• Other study ID #: STUDY00003067
• Secondary ID: UL1TR001412
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: October 30, 2023

Study information

• Verified date: November 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding
• Smoking, Cigarette

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Xiaozhong Wen	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	Breastfeeding status	During postpartum, mothers will report breastfeeding status (exclusive, mixed with formula, non-breastfeeding) every month until 6 months postpartum.	6 months postpartum
Primary	Breastfeeding frequency	During postpartum, mothers will report breastfeeding frequency (times per day) every month until 6 months postpartum.	6 months postpartum
Primary	Breastfeeding duration	During postpartum, mothers will update breastfeeding duration (weeks) every month until 6 months postpartum.	6 months postpartum
Primary	Formula duration	During postpartum, mothers will update formula duration (weeks) every month until 6 months postpartum.	6 months postpartum