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NCT Number: NCT07661550

Prevention of Postpartum Smoking Relapse and Related Health Consequences by Breastfeeding Promotion

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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 status: Recruiting

Location contact

Xiaozhong Wen

CONTACT

[email protected]

716-829-6811

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be pregnant
  • Be 18 years or older
  • Have quit smoking cigarettes during this pregnancy
  • Be willing to receive infant care and breastfeeding education
  • Be able to read, listen, and talk in English

Exclusion criteria

  • Medical conditions contraindicating breastfeeding, such as HIV infection, active tuberculosis, and breast removal
  • Current heavy drinking (≥4 standard drinks on any day or ≥8 standard drinks per week)

Treatment and study plan

Breastfeeding promotion

Behavioral

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).

Attention placebo control

Behavioral

The control group will receive instructions on general pregnancy and infant care from this project

Primary outcomes

  1. Number of participants reporting to smoke

    Time frame: 12 months postpartum

Secondary outcomes

  1. Number of participants reporting to breastfeed

    Time frame: 12months postpartum

  2. Systolic blood pressure level

    Time frame: 12 months postpartum

  3. Diastolic blood pressure level

    Time frame: 12 months postpartum

  4. Infant weight-for-length z-score

    Time frame: 12 months of age

  5. Infant length-for-age z-score

    Time frame: 12 months of age

  6. Infant head circumference

    Time frame: 12 months of age

  7. Infant arm circumference

    Time frame: 12 months of age

  8. Number of infants with bronchiolitis

    Time frame: 12 months of age

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaozhong Wen

CONTACT

[email protected]

716-829-6811

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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