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

Part of paid clinical trials in Buffalo, New York.

Sponsor
State University of New York at Buffalo
Study ID
NCT07661550
Status
Recruiting
Apply to this trial

Conditions

  • Breastfeeding
  • Smoking ( Cigarette)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Jan 1, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2030
Completion
Jul 31, 2031

Study Design

Enrollment
280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Breastfeeding intervention grou
    A multicomponent behavioral intervention to promote breastfeeding
  • Placebo Comparator: Attention placebo control group
    General infant care counseling and support

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at BuffaloBuffaloNew York14214
Xiaozhong Wen
[email protected]
716-829-6811

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By research site
Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo· Buffalo, NY

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