Smoking ( Cigarette)NCT07661550
Prevention of Postpartum Smoking Relapse and Related Health Consequences by Breastfeeding Promotion
A study testing Breastfeeding promotion in people with Smoking ( Cigarette) and Breastfeeding, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking ( Cigarette), Breastfeeding
- What is being tested?
- Breastfeeding promotion
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 31 Jul 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
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
Xiaozhong Wen, 716-829-6811, xiaozhon@buffalo.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Smoking ( Cigarette), Breastfeeding
- Being tested
- Breastfeeding promotion, Attention placebo control
- Keywords
- Pregnancy, Postpartum, Relapse
- Medical subject headings
- Cigarette Smoking, Breast Feeding, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding promotionBehavioural
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 controlBehavioural
The control group will receive instructions on general pregnancy and infant care from this project
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding intervention grou | Experimental | A multicomponent behavioral intervention to promote breastfeeding Receives: Behavioral: Breastfeeding promotion |
| Attention placebo control group | Placebo comparator | General infant care counseling and support Receives: Behavioral: Attention placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants reporting to smoke
Measured: 12 months postpartum
Secondary outcomes (8)
Number of participants reporting to breastfeed
Measured: 12months postpartum
Systolic blood pressure level
Measured: 12 months postpartum
Diastolic blood pressure level
Measured: 12 months postpartum
Infant weight-for-length z-score
Measured: 12 months of age
Infant length-for-age z-score
Measured: 12 months of age
Infant head circumference
Measured: 12 months of age
Infant arm circumference
Measured: 12 months of age
Number of infants with bronchiolitis
Measured: 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Jan 2026
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking ( Cigarette)Studies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Xiaozhong Wen, State University of New York at Buffalo
- Investigators
- Xiaozhong Wen, Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661550
- Sponsor's protocol ID
- STUDY00002632
- Other IDs
- R01HD117113
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Postpartum Smoking Relapse and Related Health Consequences by Breastfeeding Promotion
- ClinicalTrials.gov ID
- NCT07661550
- Acronym / sponsor ID
- STUDY00002632
- Conditions
- Smoking ( Cigarette), Breastfeeding
- Keywords
- Pregnancy, Postpartum, Relapse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Jul 2031 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding intervention grou | Experimental | Behavioral: Breastfeeding promotionA multicomponent behavioral intervention to promote breastfeeding |
| Attention placebo control group | Placebo comparator | Behavioral: Attention placebo controlGeneral infant care counseling and support |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breastfeeding promotionThe 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). | Behavioural | Breastfeeding intervention grou |
| Attention placebo controlThe control group will receive instructions on general pregnancy and infant care from this project | Behavioural | Attention placebo control group |
Primary outcome
Number of participants reporting to smoke
Time frame: 12 months postpartum
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaozhong Wen principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding promotion in people with Smoking ( Cigarette) and Breastfeeding, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaozhong Wen (716-829-6811, xiaozhon@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants reporting to smoke (time frame: 12 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.