NCT04601987

Brief 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. 1.the maternal health benefits of breastfeeding, or
  2. 2.the health benefits of smoke-free homes

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
451

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 26, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2023

Completed
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

1.8 years

First QC Date

August 18, 2020

Last Update Submit

January 15, 2025

Conditions

Pregnancy RelatedBreastfeedingMaternal Care Patterns

Keywords

Pregnant, breastfeeding, smokefree

Outcome Measures

Primary Outcomes (1)

  • Duration of breastfeeding

    Total number of weeks of breastfeeding

    at 6 months postpartum

Secondary Outcomes (4)

  • Knowledge of the maternal health benefits of lactation

    1 month postpartum

  • Smoke-free home policy

    6 months postpartum

  • Smoke-free home policy

    1 month postpartum

  • Duration of any breastfeeding or pumping at 24 months postpartum

    24 months postpartum

Study Arms (2)

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.

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.

Behavioral: Smokefree Homes

Interventions

BreastfeedingBEHAVIORAL

Counseling about the maternal health benefits of lactation.

Counseling about the Maternal Benefits of Breastfeeding
Smokefree HomesBEHAVIORAL

Counseling about the importance of smoke-free homes.

Counseling about the benefits of Smoke-free Homes

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsNulliparous women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Center for Healthcare Policy and Research

Sacramento, California, 95817, United States

Location

Related Publications (4)

  • 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.

    PMID: 38190278RESULT

  • Iwuagwu 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.

    PMID: 38302344RESULT

  • Hoyt-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.

    PMID: 37578450RESULT

  • Cameron 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.

    PMID: 39648739RESULT

Related Links

MeSH Terms

Conditions

Breast Feeding

Interventions

Lactation

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaPostpartum Period

Study Officials

  • Eleanor Bimla Schwarz, MD, MS

    UC Davis Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2020

First Posted

October 26, 2020

Study Start

February 1, 2021

Primary Completion

December 1, 2022

Study Completion

June 3, 2023

Last Updated

January 17, 2025

Record last verified: 2025-01

Locations

US(1)