An interventional study of Breastfeeding promotion and Attention placebo control in Smoking ( Cigarette) and Breastfeeding, sponsored by State University of New York at Buffalo. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Prevention
The objective of this randomized controlled trial is to examine the efficacy of a new intervention to prevent postpartum smoking relapse and related health consequences through breastfeeding promotion. After the pre-test, ex-smokers who are still abstinent from smoking will be randomized into either the breastfeeding intervention or the attention placebo control group. The outcomes are postpartum smoking relapse, breastfeeding practices, and maternal and child health.
We propose a randomized controlled trial to reduce postpartum smoking relapse by breastfeeding promotion from late pregnancy to 12 months postpartum. We will enroll 280 pregnant mothers who successfully quit smoking during this pregnancy (≤28 weeks). After the pre-test, participants who are still smoking abstinent will be randomized into either the breastfeeding intervention group (N=140) or the attention control group (N=140). The intervention group will receive a multicomponent intervention consisting of breastfeeding education, lactation counseling, social support, contingent financial incentives, and early limited formula milk via syringe feeding (optional for at-risk infants). The control group will receive counseling and support focusing on general infant care, with attention and monetary earnings similar to the intervention group. Both groups will receive usual care (i.e., information, education, and Quitline) for postpartum smoking relapse. The outcomes are postpartum smoking relapse, breastfeeding practices, and maternal and child health.
Aim 1 is to examine the efficacy of breastfeeding promotion intervention on postpartum smoking relapse. Aim 2 is to examine potential mediating mechanisms: reductions in stress and negative affect, enhancing mother-infant bonding and maternal sensitivity, and maternal weight retention. Aim 3 is to assess the effects of breastfeeding promotion intervention on maternal and infant health among ex-smoking mothers. This innovative study can yield promising data to support a new intervention to prevent postpartum smoking relapse. It has the potential to reduce smoking-related harms to both the mother and the infant, maximize the protective effects of breastfeeding on infant health and development, and narrow health disparities.
114 studies on the registry are indexed under Cigarette Smoking; 59 are open to participants now.
This study's planned enrollment of 280 is above the median of 100 across 101 interventional studies indexed under Cigarette Smoking.
Browse Cigarette Smoking studies →State University of New York at Buffalo is the lead sponsor of 287 studies on the registry; 65 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
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Exclusion Criteria:
A multicomponent behavioral intervention to promote breastfeeding
Behavioral: Breastfeeding promotion
General infant care counseling and support
Behavioral: Attention placebo control
The intervention group will receive a multicomponent intervention promoting breastfeeding, including education, lactation counseling, social support, breastfeeding-contingent financial incentives, and early limited formula milk via syringe feeding (optional for at-risk infants).
The control group will receive instructions on general pregnancy and infant care from this project
Number of participants reporting to smoke
Time frame: 12 months postpartum
Number of participants reporting to breastfeed
Time frame: 12months postpartum
Systolic blood pressure level
Time frame: 12 months postpartum
Diastolic blood pressure level
Time frame: 12 months postpartum
Infant weight-for-length z-score
Time frame: 12 months of age
Infant length-for-age z-score
Time frame: 12 months of age
Infant head circumference
Time frame: 12 months of age
Infant arm circumference
Time frame: 12 months of age
Number of infants with bronchiolitis
Time frame: 12 months of age
Plan to share: No
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State University of New York at Buffalo