Recruiting

Breastfeeding Intervention

Sponsor:

State University of New York at Buffalo

Code:

NCT07661550

Conditions

Smoking ( Cigarette)

Breastfeeding

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Breastfeeding promotion

Attention placebo control

Study Details

Brief summary:

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.

Conditions

Smoking ( Cigarette)

Breastfeeding

Study ID

NCT07661550

Start date

Jan 1, 2026

Status verified date

Jun, 2026

Completion date

Jul 31, 2031

Anticipated

Primary completion date

Jul 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

280 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Breastfeeding intervention grou

A multicomponent behavioral intervention to promote breastfeeding

placebo comparator: Attention placebo control group

General infant care counseling and support

Interventions

Breastfeeding promotion

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

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

Primary outcome measure

  • Number of participants reporting to smoke [ Time Frame: 12 months postpartum ]

Central Contacts and Locations

Central contacts

Xiaozhong Wen

716-829-6811xiaozhon@buffalo.edu

Locations

Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo

Recruiting

Buffalo, New York, United States, 14214

Contacts

Xiaozhong Wen

716-829-6811xiaozhon@buffalo.edu

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • Pregnancy
  • Postpartum
  • Relapse

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-06-22.