Smoking, CigaretteNCT04670822
Postpartum Smoking Relapse Prevention 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
This is a randomized controlled trial to prevent postpartum smoking relapse by breastfeeding promotion. The intervention group (N=30) will receive multicomponent breastfeeding intervention from late pregnancy to 6 months postpartum, while the attention placebo control group (N=30) will receive general infant care… 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
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 or in the first 1 month postpartum
- Be 18 years or older
- Have quit smoking cigarettes during or before 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 (more than 2 drinks a day)
- Current use of illicit substances
- Being strongly against breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
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
About this study
This is a randomized controlled trial to prevent postpartum smoking relapse by breastfeeding promotion. The intervention group (N=30) will receive multicomponent breastfeeding intervention from late pregnancy to 6 months postpartum, while the attention placebo control group (N=30) will receive general infant care counseling and support. The key outcome is the rate of postpartum smoking relapse.
Read the detailed description
The investigators propose the first randomized controlled trial to reduce postpartum smoking relapse by breastfeeding promotion from late pregnancy to 6 months postpartum. The investigators will enroll 60 pregnant women who successfully quit smoking within 3 months before or during this pregnancy (<28 weeks). All participants will receive breastfeeding education during late pregnancy. Right after delivery, participants who are still smoking abstinent will be randomized into either the breastfeeding intervention group (N=30) or the attention placebo control group (N=30). The intervention group will receive multicomponent interventions consisting of postnatal lactation counseling, family/peer/employer support, contingent financial incentives, and early limited formula milk via syringe (optional for at-risk infants). The control group will receive counseling and support focusing on general infant care with attention and compensation similar to the intervention group. The primary outcomes are rates of postpartum smoking relapse verified by urine cotinine test.
Specific Aim 1 is to examine the efficacy of breastfeeding promotion intervention on postpartum smoking relapse. Specific Aim 2 is to collect preliminary data regarding potential mediating mechanisms: increases in lactation hormones (plasma oxytocin and prolactin), reductions in stress and negative affect, and enhancing mother-infant bonding and maternal motivation to protect the infant from secondhand smoke exposure. This innovative and feasible pilot study can yield promising preliminary data to strongly support our future application of a NIH R01 grant proposal that has the potential to reduce smoking-related harms to both the mother and the infant, and maximize the protective effects of breastfeeding on infant health and development.
- Conditions
- Smoking, Cigarette, Breastfeeding
- Being tested
- Breastfeeding promotion, Attention placebo control
- Keywords
- 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 multicomponent interventions consisting of 7 half-hour postnatal visits for lactation counseling, family/peer/employer support, contingent financial incentives, and early limited formula milk via syringe (optional for at-risk infants).
Attention placebo controlBehavioural
The attention placebo control group will complete the same frequency and duration of study visits as the intervention group but focus on general infant care counseling and support.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding intervention group | 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 Breastfeed
During postpartum, mothers report their breastfeeding status (exclusive, mixed with formula, non-breastfeeding) every month until 9 months postpartum. Any breastfeeding is defined as exclusive breastfeeding or mixed-feeding breast milk and formula.
Measured: 9 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start31 Jul 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking, CigaretteStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), 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
- NCT04670822
- Sponsor's protocol ID
- MODCR00004712
- Other IDs
- R21HD091515
- Status last verified
- May 2025
- First submitted
- 10 Dec 2020
- Last updated
- 15 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Smoking Relapse Prevention by Breastfeeding Promotion
- ClinicalTrials.gov ID
- NCT04670822
- Acronym / sponsor ID
- MODCR00004712
- Conditions
- Smoking, Cigarette, Breastfeeding
- Keywords
- Postpartum, Relapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Posted 15 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial to prevent postpartum smoking relapse by breastfeeding promotion. The intervention group (N=30) will receive multicomponent breastfeeding intervention from late pregnancy to 6 months postpartum, while the attention placebo control group (N=30) will receive general infant care counseling and support. The key outcome is the rate of postpartum smoking relapse.
Detailed description
The investigators propose the first randomized controlled trial to reduce postpartum smoking relapse by breastfeeding promotion from late pregnancy to 6 months postpartum. The investigators will enroll 60 pregnant women who successfully quit smoking within 3 months before or during this pregnancy (<28 weeks). All participants will receive breastfeeding education during late pregnancy. Right after delivery, participants who are still smoking abstinent will be randomized into either the breastfeeding intervention group (N=30) or the attention placebo control group (N=30). The intervention group will receive multicomponent interventions consisting of postnatal lactation counseling, family/peer/employer support, contingent financial incentives, and early limited formula milk via syringe (optional for at-risk infants). The control group will receive counseling and support focusing on general infant care with attention and compensation similar to the intervention group. The primary outcomes are rates of postpartum smoking relapse verified by urine cotinine test.
Specific Aim 1 is to examine the efficacy of breastfeeding promotion intervention on postpartum smoking relapse. Specific Aim 2 is to collect preliminary data regarding potential mediating mechanisms: increases in lactation hormones (plasma oxytocin and prolactin), reductions in stress and negative affect, and enhancing mother-infant bonding and maternal motivation to protect the infant from secondhand smoke exposure. This innovative and feasible pilot study can yield promising preliminary data to strongly support our future application of a NIH R01 grant proposal that has the potential to reduce smoking-related harms to both the mother and the infant, and maximize the protective effects of breastfeeding on infant health and development.
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 group | 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 or in the first 1 month postpartum
- Be 18 years or older
- Have quit smoking cigarettes during or before this pregnancy
- Be willing to receive infant care and breastfeeding education
- Be able to read, listen, and talk in English
Key exclusion criteria (4 listed)
- Medical conditions contraindicating breastfeeding such as HIV infection, active tuberculosis, and breast removal
- Current heavy drinking (more than 2 drinks a day)
- Current use of illicit substances
- Being strongly against breastfeeding
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 multicomponent interventions consisting of 7 half-hour postnatal visits for lactation counseling, family/peer/employer support, contingent financial incentives, and early limited formula milk via syringe (optional for at-risk infants). | Behavioural | Breastfeeding intervention group |
| Attention placebo controlThe attention placebo control group will complete the same frequency and duration of study visits as the intervention group but focus on general infant care counseling and support. | Behavioural | Attention placebo control group |
Primary outcome
Number of Participants Reporting to Breastfeed
Time frame: 9 months postpartum
During postpartum, mothers report their breastfeeding status (exclusive, mixed with formula, non-breastfeeding) every month until 9 months postpartum. Any breastfeeding is defined as exclusive breastfeeding or mixed-feeding breast milk and formula.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
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 4 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: finished, as of the sponsor's last update on 15 May 2025. 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?
Yes. Results are posted in the registry (first posted 15 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting to Breastfeed (time frame: 9 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 15 May 2025.