Healthy Moms: Prenatal Counseling for Postpartum Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

451 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2023-06-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Postpartum Smoking Relapse Prevention by Breastfeeding Promotion

NCT04670822

Smoking, Cigarette Breastfeeding

COMPLETED NA

SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers

NCT06030830

Smartphone Addiction Breastfeeding Infant Behavior +1 more

RECRUITING NA

Prenatal Intervention of Maternal Stress - Breastfeeding & Infant Neurodevelopment

NCT06876051

Stress Relaxation Breastfeeding +2 more

COMPLETED NA

Prenatal Lactation-Focused Motivational Interviewing

NCT03033459

Breast Feeding Lactation Puerperal Increased Infant Behavior +1 more

COMPLETED NA

The Effect of Antenatal Education Based on the Breastfeeding Self-Efficacy Theory and Postpartum Follow-Up Counseling on Breastfeeding Self-Efficacy and Attitudes in Adolescent Pregnant Women

NCT07025265

Adolescent Pregnancy Breastfeeding Self-Efficacy

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Related Breastfeeding Maternal Care Patterns

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Breastfeeding

Intervention Type BEHAVIORAL

Counseling about the maternal health benefits of lactation.

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.

Group Type ACTIVE_COMPARATOR

Smokefree Homes

Intervention Type BEHAVIORAL

Counseling about the importance of smoke-free homes.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Breastfeeding

Counseling about the maternal health benefits of lactation.

Intervention Type BEHAVIORAL

Smokefree Homes

Counseling about the importance of smoke-free homes.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes