Pregnancy RelatedNCT04601987
Healthy Moms: Prenatal Counseling for Postpartum Health
A study testing Breastfeeding and Smokefree Homes in people with Pregnancy Related and Breastfeeding, run by University of California, Davis at 1 site in United States.
Trial summary
See https://studypages.com/s/healthy-moms-study-765273 This individual-level randomized trial involves pregnant women followed for at least 6 months after delivery, to compare the effects of providing two "attention-control" counseling interventions designed to increase pregnant women's awareness of either: 1. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Breastfeeding, Maternal Care Patterns
- What is being tested?
- Breastfeeding and Smokefree Homes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 451 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 3 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nulliparous women who are carrying a singleton pregnancy between 27-37 weeks gestation
- Born in the United States
- Aged 18-40 years
- Able to read English
- Have reliable access to a telephone that is able to send and receive text messages
- Have reliable access to a smart phone, tablet, computer, or other device with access to the internet
Who cannot join
- Women carrying multiple gestations
- Diagnosed with HIV or are advised by a clinician not to breastfeed for any other reason
- Have undergone mastectomy or breast reduction surgery
- Unable to speak English, or who do not have a telephone or respond to text messages
- Carrying a surrogate pregnancy or are not planning to parent after giving birth
- Became pregnant through use of assisted reproductive technology such as in vitro fertilization (IVF)
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Center for Healthcare Policy and Research
Sacramento, California, 95817
About this study
See https://studypages.com/s/healthy-moms-study-765273
This individual-level randomized trial involves pregnant women followed for at least 6 months after delivery, to compare the effects of providing two "attention-control" counseling interventions designed to increase pregnant women's awareness of either:
- the maternal health benefits of breastfeeding, or
- the health benefits of smoke-free homes
Read the detailed description
The investigators will conduct an individual-level randomized trial involving pregnant women to compare the effects on infant feeding practices of providing pregnant women information about the maternal health benefits of breastfeeding to usual prenatal counseling focused on the infant health benefits of breastfeeding. Participants will be randomly allocated to one of two equal sized groups by research assistants using a web-based random number generator that conceals allocation. Participants will be recruited online via UC Davis' StudyPages website. Screening will occur online at the participant's convenience. When screening criteria have been met, the research coordinator will be notified, and initiate contact with the participant by text and/or phone call to schedule a time to deliver the intervention. Due to social distancing measures that have been put into place as a result of the COVID-19 pandemic, informed consent will be collected digitally using the Qualtrics platform after potential participants complete a secondary screening survey. Consenting participants will use Qualtrics to complete a baseline/enrollment survey and be randomized and then scheduled for a time to receive their allocated counseling intervention using the Zoom platform. Follow-up surveys will be distributed to participants at 1, 3, 6, 9 and 12 months postpartum.
Comparators:
Participants randomized to the "intervention group" will receive information about the maternal health benefits of breastfeeding from a research assistant who also will provide information on resources designed to support prenatal and postpartum health, including breastfeeding support groups. Participants will be presented with a series of images to look at while listening to the scripted counseling, including an image developed in 2002 by the Ad Council designed to convey a link between bottle-feeding and insulin use, as well as images developed specifically for use when counseling women about the maternal benefits of breastfeeding.
The "attention control" group will receive "usual care" from their prenatal care provider that focuses on the infant health benefits of breastfeeding. To control for the potential effects of receiving additional attention from a counselor, pregnant women enrolled in the control arm of this study will receive information from a peer counselor on the health benefits of "smoke- and weed-free homes".
The investigators will thoroughly train all research staff on the critical importance of delivering only the allocated counseling intervention to each study participant. The investigators will monitor intervention delivery by audio-recording staff interactions with study participants, and providing prompt feedback to research staff, if needed.
Intervention Delivery: These scripted counseling interventions were designed to be understood by those with no more than a fifth-grade education and to take less than 5 minutes to deliver. All research staff will be trained by the PI to ensure they understand the importance of maintaining the integrity of study group allocation and delivering only the assigned scripted counseling. After receiving their allocated counseling, participants will be emailed the images and script and encouraged to share this information with the people they anticipate receiving postpartum support from.
- Conditions
- Pregnancy Related, Breastfeeding, Maternal Care Patterns
- Being tested
- Breastfeeding, Smokefree Homes
- Keywords
- Pregnant, breastfeeding, smokefree
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreastfeedingBehavioural
Counseling about the maternal health benefits of lactation.
Smokefree HomesBehavioural
Counseling about the importance of smoke-free homes.
| Study group | Role | What they receive |
|---|---|---|
| Counseling about the Maternal Benefits of Breastfeeding | Active comparator | Participants will review a slide deck while receiving scripted counseling designed to increase understanding of the maternal health benefits of breastfeeding. Receives: Behavioral: Breastfeeding |
| Counseling about the benefits of Smoke-free Homes | Active comparator | Participants will review a slide deck while receiving scripted counseling designed to increase understanding of the health benefits of smoke free homes. Receives: Behavioral: Smokefree Homes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of breastfeeding
Total number of weeks of breastfeeding
Measured: at 6 months postpartum
Secondary outcomes (4)
Knowledge of the maternal health benefits of lactation
Change in participant knowledge before and after receipt of this counseling intervention will be assessed by asking participants to respond (true, false, don't know) whether they believe Breastfeeding will…
- lower my risk of breast cancer.
- lower my risk of ovarian cancer.
- lower my risk of developing diabetes.
- increase my risk of a breast infection.
- increase my risk of depression [reverse coded]
- make it harder to "get my body back" after my baby is born. [reverse coded]
- protect my hands from arthritis.
- lower my blood pressure and risk of heart disease.
- lower my libido/sex drive.
- delay my menstrual period after my baby is born.
- save my family money."
Measured: 1 month postpartum
Smoke-free home policy
Investigators will compare the proportion of individuals who have a "smoke-free" policy for their homes as assessed by responding with option "d" when presented with the following options "Which of the following statements best describes the rules about smoking inside your home now, even if no one who lives in your home is a smoker? Select ONE answer
- Smoking is permitted anywhere inside my home
- Smoking is permitted inside my home by an open window
- Smoking is allowed in some rooms or at some times
- No one is allowed to smoke anywhere inside my home
Measured: 6 months postpartum
Smoke-free home policy
Investigators will compare the proportion of individuals who have a "smoke-free" policy for their homes as assessed by responding with option "d" when presented with the following options "Which of the following statements best describes the rules about smoking inside your home now, even if no one who lives in your home is a smoker? Select ONE answer
- Smoking is permitted anywhere inside my home
- Smoking is permitted inside my home by an open window
- Smoking is allowed in some rooms or at some times
- No one is allowed to smoke anywhere inside my home
Measured: 1 month postpartum
Duration of any breastfeeding or pumping at 24 months postpartum
Investigators will compare the duration of any breastfeeding or pumping reported through 24 months
Measured: 24 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start1 Feb 2021
- Primary completion1 Dec 2022
- Study completion3 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Sponsor
- Investigators
- Eleanor Bimla Schwarz, MD, MS, Principal investigator, UC Davis Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601987
- Sponsor's protocol ID
- 1623168
- Status last verified
- Jan 2025
- First submitted
- 18 Aug 2020
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schwarz EB, Hoyt-Austin A, Fix M, Kair LR, Iwuagwu C, Chen MJ. Prenatal Counseling on the Maternal Health Benefits of Lactation: A Randomized Trial. Breastfeed Med. 2024 Jan;19(1):52-58. doi: 10.1089/bfm.2023.0219. Epub 2024 Jan 8.
PubMed 38190278Iwuagwu C, Chen MJ, Hoyt-Austin AE, Kair L, Fix M, Schwarz EB. Awareness of the Maternal Health Benefits of Lactation Among U.S. Pregnant Individuals. Womens Health Issues. 2024 May-Jun;34(3):283-290. doi: 10.1016/j.whi.2023.12.004. Epub 2024 Feb 1.
PubMed 38302344Hoyt-Austin A, Chen MJ, Iwuagwu C, Brown SD, Fix M, Kair LR, Schwarz EB. Understanding of Lactational Amenorrhea As a Contraceptive Method Among U.S. Pregnant Women. Breastfeed Med. 2023 Aug;18(8):621-625. doi: 10.1089/bfm.2023.0105. Epub 2023 Aug 7.
PubMed 37578450Cameron NA, Begna H, Schwarz EB. Blood Pressure Monitoring and Knowledge in the First Year after a Hypertensive Disorder of Pregnancy. J Womens Health (Larchmt). 2025 Apr;34(4):485-490. doi: 10.1089/jwh.2024.0798. Epub 2024 Dec 9.
PubMed 39648739
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Moms: Prenatal Counseling for Postpartum Health
- ClinicalTrials.gov ID
- NCT04601987
- Acronym / sponsor ID
- 1623168
- Conditions
- Pregnancy Related, Breastfeeding, Maternal Care Patterns
- Keywords
- Pregnant, breastfeeding, smokefree
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 3 Jun 2023 (actual)
- First posted
- 26 Oct 2020 (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.
See https://studypages.com/s/healthy-moms-study-765273
This individual-level randomized trial involves pregnant women followed for at least 6 months after delivery, to compare the effects of providing two "attention-control" counseling interventions designed to increase pregnant women's awareness of either:
- the maternal health benefits of breastfeeding, or
- the health benefits of smoke-free homes
Detailed description
The investigators will conduct an individual-level randomized trial involving pregnant women to compare the effects on infant feeding practices of providing pregnant women information about the maternal health benefits of breastfeeding to usual prenatal counseling focused on the infant health benefits of breastfeeding. Participants will be randomly allocated to one of two equal sized groups by research assistants using a web-based random number generator that conceals allocation. Participants will be recruited online via UC Davis' StudyPages website. Screening will occur online at the participant's convenience. When screening criteria have been met, the research coordinator will be notified, and initiate contact with the participant by text and/or phone call to schedule a time to deliver the intervention. Due to social distancing measures that have been put into place as a result of the COVID-19 pandemic, informed consent will be collected digitally using the Qualtrics platform after potential participants complete a secondary screening survey. Consenting participants will use Qualtrics to complete a baseline/enrollment survey and be randomized and then scheduled for a time to receive their allocated counseling intervention using the Zoom platform. Follow-up surveys will be distributed to participants at 1, 3, 6, 9 and 12 months postpartum.
Comparators:
Participants randomized to the "intervention group" will receive information about the maternal health benefits of breastfeeding from a research assistant who also will provide information on resources designed to support prenatal and postpartum health, including breastfeeding support groups. Participants will be presented with a series of images to look at while listening to the scripted counseling, including an image developed in 2002 by the Ad Council designed to convey a link between bottle-feeding and insulin use, as well as images developed specifically for use when counseling women about the maternal benefits of breastfeeding.
The "attention control" group will receive "usual care" from their prenatal care provider that focuses on the infant health benefits of breastfeeding. To control for the potential effects of receiving additional attention from a counselor, pregnant women enrolled in the control arm of this study will receive information from a peer counselor on the health benefits of "smoke- and weed-free homes".
The investigators will thoroughly train all research staff on the critical importance of delivering only the allocated counseling intervention to each study participant. The investigators will monitor intervention delivery by audio-recording staff interactions with study participants, and providing prompt feedback to research staff, if needed.
Intervention Delivery: These scripted counseling interventions were designed to be understood by those with no more than a fifth-grade education and to take less than 5 minutes to deliver. All research staff will be trained by the PI to ensure they understand the importance of maintaining the integrity of study group allocation and delivering only the assigned scripted counseling. After receiving their allocated counseling, participants will be emailed the images and script and encouraged to share this information with the people they anticipate receiving postpartum support from.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counseling about the Maternal Benefits of Breastfeeding | Active comparator | Behavioral: BreastfeedingParticipants will review a slide deck while receiving scripted counseling designed to increase understanding of the maternal health benefits of breastfeeding. |
| Counseling about the benefits of Smoke-free Homes | Active comparator | Behavioral: Smokefree HomesParticipants will review a slide deck while receiving scripted counseling designed to increase understanding of the health benefits of smoke free homes. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Nulliparous women who are carrying a singleton pregnancy between 27-37 weeks gestation
- Born in the United States
- Aged 18-40 years
- Able to read English
- Have reliable access to a telephone that is able to send and receive text messages
Key exclusion criteria (6 listed)
- Women carrying multiple gestations
- Diagnosed with HIV or are advised by a clinician not to breastfeed for any other reason
- Have undergone mastectomy or breast reduction surgery
- Unable to speak English, or who do not have a telephone or respond to text messages
- Carrying a surrogate pregnancy or are not planning to parent after giving birth
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 |
|---|---|---|
| BreastfeedingCounseling about the maternal health benefits of lactation. | Behavioural | Counseling about the Maternal Benefits of Breastfeeding |
| Smokefree HomesCounseling about the importance of smoke-free homes. | Behavioural | Counseling about the benefits of Smoke-free Homes |
Primary outcome
Duration of breastfeeding
Time frame: at 6 months postpartum
Total number of weeks of breastfeeding
4 secondary outcomes
Knowledge of the maternal health benefits of lactation
Time frame: 1 month postpartum
Smoke-free home policy
Time frame: 6 months postpartum
Smoke-free home policy
Time frame: 1 month postpartum
Duration of any breastfeeding or pumping at 24 months postpartum
Time frame: 24 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Results publication: PubMed 38190278Schwarz EB, Hoyt-Austin A, Fix M, Kair LR, Iwuagwu C, Chen MJ. Prenatal Counseling on the Maternal Health Benefits of Lactation: A Randomized Trial. Breastfeed Med. 2024 Jan;19(1):52-58. doi: 10.1089/bfm.2023.0219. Epub 2024 Jan 8.
- Results publication: PubMed 38302344Iwuagwu C, Chen MJ, Hoyt-Austin AE, Kair L, Fix M, Schwarz EB. Awareness of the Maternal Health Benefits of Lactation Among U.S. Pregnant Individuals. Womens Health Issues. 2024 May-Jun;34(3):283-290. doi: 10.1016/j.whi.2023.12.004. Epub 2024 Feb 1.
- Results publication: PubMed 37578450Hoyt-Austin A, Chen MJ, Iwuagwu C, Brown SD, Fix M, Kair LR, Schwarz EB. Understanding of Lactational Amenorrhea As a Contraceptive Method Among U.S. Pregnant Women. Breastfeed Med. 2023 Aug;18(8):621-625. doi: 10.1089/bfm.2023.0105. Epub 2023 Aug 7.
- Results publication: PubMed 39648739Cameron NA, Begna H, Schwarz EB. Blood Pressure Monitoring and Knowledge in the First Year after a Hypertensive Disorder of Pregnancy. J Womens Health (Larchmt). 2025 Apr;34(4):485-490. doi: 10.1089/jwh.2024.0798. Epub 2024 Dec 9.
- Learn more or sign up for the study here!Link provided by the sponsor.
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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.
Eleanor Bimla Schwarz, MD, MS principal investigator
UC Davis Health
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 and Smokefree Homes in people with Pregnancy Related and Breastfeeding, run by University of California, Davis 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 6 inclusion and 6 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 17 Jan 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Duration of breastfeeding (time frame: at 6 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04601987, which also lists 4 linked publications.
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 17 Jan 2025.