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Healthy Moms: Prenatal Counseling for Postpartum Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04601987
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : December 3, 2020
Sponsor:
Collaborator:
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:

The study investigators will conduct an individual-level randomized trial involving 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. the maternal health benefits of breastfeeding, or
  2. the health benefits of smoke-free homes

Condition or disease Intervention/treatment Phase
Pregnancy Related Breastfeeding Maternal Care Patterns Behavioral: Breastfeeding Behavioral: Smokefree Homes Not Applicable

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 walk through installation of the Daily Connect/Baby Connect phone application which participants will be able to use infant feeding data. 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 then 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Healthy Moms: Prenatal Counseling for Postpartum Health
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 15, 2022
Estimated Study Completion Date : June 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Active Comparator: Counseling about the Maternal Benefits of Breastfeeding
Participants will review a slide deck while receiving scripted counseling designed to increase understanding of the maternal health benefits of breastfeeding.
Behavioral: Breastfeeding
Counseling about the maternal health benefits of lactation.

Active Comparator: Counseling about the benefits of Smoke-free Homes
Participants will review a slide deck while receiving scripted counseling designed to increase understanding of the health benefits of smoke free homes.
Behavioral: Smokefree Homes
Counseling about the importance of smoke-free homes.




Primary Outcome Measures :
  1. Duration of breastfeeding [ Time Frame: at 6 months postpartum ]
    Total number of weeks of breastfeeding


Secondary Outcome Measures :
  1. Knowledge of the maternal health benefits of lactation [ Time Frame: 1 month postpartum ]

    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…

    1. lower my risk of breast cancer.
    2. lower my risk of ovarian cancer.
    3. lower my risk of developing diabetes.
    4. increase my risk of a breast infection.
    5. increase my risk of depression [reverse coded]
    6. make it harder to "get my body back" after my baby is born. [reverse coded]
    7. protect my hands from arthritis.
    8. lower my blood pressure and risk of heart disease.
    9. lower my libido/sex drive.
    10. delay my menstrual period after my baby is born.
    11. save my family money."

  2. Smoke-free home policy [ Time Frame: 6 months postpartum ]

    We 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

    1. Smoking is permitted anywhere inside my home
    2. Smoking is permitted inside my home by an open window
    3. Smoking is allowed in some rooms or at some times
    4. No one is allowed to smoke anywhere inside my home

  3. Smoke-free home policy [ Time Frame: 1 month postpartum ]

    We 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

    1. Smoking is permitted anywhere inside my home
    2. Smoking is permitted inside my home by an open window
    3. Smoking is allowed in some rooms or at some times
    4. No one is allowed to smoke anywhere inside my home



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Nulliparous women
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04601987


Contacts
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Contact: Iesha Miller, MHA 916-734-3269 itmiller@ucdavis.edu
Contact: Marykate Miller, MS 916-734-2877 hs-healthymomsstudy@ucdavis.edu

Locations
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United States, California
UC Davis Center for Healthcare Policy and Research Recruiting
Sacramento, California, United States, 95817
Contact: Eleanor B Schwarz, MD    916-734-5453    ebschwarz@ucdavis.edu   
Contact: Marykate Miller, MS    916-734-2877    mkemiller@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Health Resources and Services Administration (HRSA)
Investigators
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Principal Investigator: Eleanor Bimla Schwarz, MD, MS UC Davis Health
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04601987    
Other Study ID Numbers: 1623168
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, Davis:
Pregnant, breastfeeding, smokefree