Pre-Pregnancy Counseling for Preconception Health

(Project IMPACT Trial)

Overseen By Adenike McDonald, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Morehouse School of Medicine

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

850 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new approach to improving heart health before pregnancy through pre-pregnancy counseling. The trial implements the SBIRT intervention, a structured program that helps identify and reduce health risks, in community settings. Participants will receive either standard follow-up with informational flyers and text messages or enhanced follow-up with additional phone messages. It is designed for Black or African-American individuals who speak English, are not pregnant, and receive services at specific community sites. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the SBIRT (Screening, Brief Intervention, and Referral to Treatment) method is generally safe for people. Studies have found it effective in spotting and reducing alcohol use during pregnancy, indicating it is well-tolerated. No reports of serious side effects have been linked to SBIRT.

SBIRT is widely used with women to address substance use. It helps identify risks and encourages positive changes without causing harm. This approach focuses on guidance and support rather than medical or drug treatments, often resulting in fewer side effects.

Since this trial is in a later phase, earlier studies found the treatment safe enough to test with more people. Overall, current evidence suggests that the SBIRT method is a safe option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on improving preconception health through a unique approach called SBIRT (Screening, Brief Intervention, and Referral to Treatment). Unlike typical pre-pregnancy care that might focus mainly on medical check-ups, this method integrates behavioral health strategies to address cardiovascular risks before pregnancy. The trial includes two experimental follow-up methods: one with standard follow-up using flyers and text messaging, and another with enhanced follow-up involving more personalized text or phone messages. By employing community organization staff for delivery, the trial aims to make pre-pregnancy counseling more accessible and tailored to individual needs, potentially leading to better health outcomes for future pregnancies.

What evidence suggests that this trial's treatments could be effective for preconception health?

Research has shown that the SBIRT approach, which stands for Screening, Brief Intervention, and Referral to Treatment, effectively reduces alcohol use during pregnancy. One study found that 83% of women who used substances stopped using at least one substance during pregnancy after participating in SBIRT. This method identifies women at risk and reduces the likelihood of continued drinking. SBIRT involves a conversation that raises awareness of the risks of substance use and encourages positive changes. In this trial, all participants will receive the SBIRT intervention, with some receiving additional support through either Standard Structured Follow-Up or Enhanced Structured Follow-Up. Overall, SBIRT is a promising way to improve health before pregnancy. ^{2 4 6 7 8}

Who Is on the Research Team?

Natalie D. Hernandez, PhD

Principal Investigator

Associate Professor

Cheryl Franklin, MD

Principal Investigator

AssociateProfessor

Oluyemi Farinu, PhD

Principal Investigator

Project Director

Are You a Good Fit for This Trial?

This trial is for Black/African-American individuals who speak English fluently, are not currently pregnant, own a phone, and receive services at the community-based site involved in the study. It aims to improve preconception health.

Inclusion Criteria

Self-identify as Black/African-American

Fluent English-Speaker

Not pregnant at the time of enrollment

Timeline for a Trial Participant

Exploration

Initial phase to identify and engage with community partners and settings for preconception counseling interventions.

6 months

Preparation

Tailoring of implementation strategy packages and Project IMPACT intervention to the context of 10 sites across 4 states.

6 months

Implementation

Testing of Enhanced vs. Standard implementation strategy package of structured follow-up on pre-conception counseling visits.

6 months

Multiple visits (in-person and virtual)

Sustainment

Co-development of an implementation and sustainment guide for the most effective strategy bundle.

6 months

Follow-up

Participants are monitored for effectiveness and readiness to change for key cardiovascular risk factors.

3.5 years

Surveys at baseline, 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• SBIRT Intervention

Trial Overview The study tests how well Pre-Pregnancy Counseling can be implemented in community settings to enhance maternal health before conception using an intervention known as SBIRT (Screening, Brief Intervention, and Referral to Treatment).

How Is the Trial Designed?

Group I: Standard Structured Follow-Up Experimental Treatment 1 Intervention

Emailed informational flyer(s) on prioritized cardiovascular risks and text messaging for logistical reasons. These will be in addition to the SBIRT intervention delivered by Healthy Start and other similar community organization staff that all participants will receive.

Group II: Enhanced Structured Follow-Up Experimental Treatment 1 Intervention

Text or phone message(s) focused on the same prioritized risks + emailed informational flyer(s). These will be in addition to the SBIRT intervention delivered by Healthy Start and other similar community organization staff that all participants will receive.

Who Is Running the Clinical Trial?

Morehouse School of Medicine

Lead Sponsor

Trials

22

Recruited

16,300+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Women at higher risk for complications during pregnancy, such as older age or a history of pregnancy loss, can significantly benefit from preconception counseling to minimize risks to both mother and baby.

Preconception counseling helps inform these women about potential risks and available options, which can only be effectively utilized if discussed before conception, highlighting the physician's role in facilitating this process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preconceptional counseling. Taysi, K.[2007]

Interventions by obstetric caregivers, such as brief interventions and motivational interviewing, have been shown to effectively reduce alcohol consumption among women, even those who drink heavily, before, during, and after pregnancy.

Implementing a stepped-care approach allows healthcare providers to deliver these interventions efficiently, helping to prevent drinking during pregnancy while managing costs and clinic resources effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interventions in prenatal clinics. Handmaker, NS., Wilbourne, P.[2023]

The implementation of the SBIRT (Screening, Brief Intervention, and Referral to Treatment) tool into electronic health records (EHR) at three prenatal clinics showed varying performance rates, with the generalist practice achieving an 85% screening rate, indicating effective integration into prenatal care.

Out of 2,619 encounters, only 5.1% of women in the resident clinic reported substance use, highlighting the importance of universal screening in identifying and addressing substance use during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Screening, Brief Intervention and Referral to Treatment (SBIRT) for Substance Use into Prenatal Care. Hostage, JC., Brock, J., Craig, W., et al.[2022]

Implementing Screening, Brief Intervention, and Referral to Treatment (SBIRT) for pregnant women is crucial to identify those at risk of alcohol consumption, which can harm both maternal and child health.

The study proposes new performance measures to track the screening and intervention rates for alcohol use in prenatal care, aiming to improve the implementation of SBIRT and support pregnant women in reducing alcohol consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance measurement: a proposal to increase use of SBIRT and decrease alcohol consumption during pregnancy. O'Brien, PL.[2021]

A new bilingual computerized Screening and Brief Intervention (SBI) program for alcohol and sugar-sweetened beverage use was tested with 290 pregnant women, showing high feasibility and acceptability, with 87% completing the program.

The program identified prenatal alcohol use in 21% of participants, significantly higher than the 13% identified through traditional in-person screening, indicating its effectiveness in detecting alcohol use during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a novel, computerized screening and brief intervention (SBI) for alcohol and sweetened beverage use in pregnancy. Nayak, MB., Korcha, RA., Kaskutas, LA., et al.[2019]

Citations

1. amchp.org amchp.org/wp-content/uploads/2022/01/AMCHP-NASADAD-SBIRT-Issue-Brief-October-2020.pdf

Screening, Brief Intervention, and Referral to Treatment ( ... One study indicates that while 83 percent of women who use substances achieve abstinence from at least one substance during pregnancy, by three months.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3711957/

Performance Measurement: A Proposal to Increase Use of ... ... SBIRT are key steps towards effective intervention and reduction of alcohol consumption during pregnancy. ... Healthcare Effectiveness Data and Information ...

3. withpower.com withpower.com/trial/pre-pregnancy-counseling-for-preconception-health-a9a9c

Pre-Pregnancy Counseling for Preconception Health Research shows that SBIRT, when used during pregnancy, helps identify women at risk of alcohol consumption and reduces the likelihood of continued drinking, ...

4. cpeip.fsu.edu cpeip.fsu.edu/mma/documents/ECHO%20ObGyn%20Brief%207%20-%20SUD%20In%20Pregnancy%20SBIRT.pdf

Screening, Brief Intervention, Referral and Treatment (SBIRT) Brief interventions consist of a dialogue with the patient that provides awareness of the consequences of substance use during pregnancy and provides motivation.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05910580

Improving Alcohol and Substance Use Care Access ... The goal of this clinical trial is to test the effectiveness of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adult ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7413672/

Screening, Brief Intervention, and Referral to Treatment for ... The purpose of the study was to determine current practices, barriers to implementation, and education needs of healthcare providers utilizing SBIRT to address ...

7. womensmentalhealth.org womensmentalhealth.org/posts/essential-reads-sbirt-for-women-with-alcohol-and-drug-use-during-pregnancy/

Essential Reads: SBIRT for Women with Alcohol and Drug ... Screening, Brief Intervention and Referral to Treatment or SBIRT has been shown to be a quick and effective means of identifying and intervening with patients ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10692260/

Early Insights into Implementation of Universal Screening ... Universal screening, brief intervention, and referral to treatment (SBIRT) is one systems-level approach to addressing perinatal substance use.