Health TrialsbyHealthPanel

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

ConditionsSmoking ( Cigarette)Breastfeeding
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorState University of New York at Buffalo

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Be pregnant

Be 18 years or older

Have quit smoking cigarettes during this pregnancy

Be willing to receive infant care and breastfeeding education

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: Breastfeeding intervention grouExperimental treatment 1 intervention
Group B: Attention placebo control groupPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

State University of New York at Buffalo

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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