Recruiting
Phase 2

Pre-Pregnancy Counseling

Sponsor:

Morehouse School of Medicine

Code:

NCT05987059

Conditions

Preconception Health

Eligibility Criteria

Sex: All

Age: 18 - 44

Healthy Volunteers: Accepted

Interventions

SBIRT Intervention

Study Details

Brief summary:

With support from the National Heart, Lung, and Blood Institute, The Center for Maternal Health Equity at Morehouse School of Medicine is conducting a research study to test the implementation of Pre-Pregnancy Counseling in community-based settings.

Conditions

Preconception Health

Study ID

NCT05987059

Start date

Jan 1, 2024

Status verified date

Nov, 2024

Completion date

Dec, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 44

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Self-identify as Black/ African-American
  • Fluent English-Speaker
  • Not pregnant at the time of enrollment
  • Own a phone
  • Receive services at the community-based site

Exclusion Criteria:

\-

Study Design

Enrollment

850 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Standard Structured Follow-Up

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.

experimental: Enhanced Structured Follow-Up

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.

Interventions

SBIRT Intervention

Project IMPACT intervention will follow a Screening, Brief Intervention, and Referral to Treatment (SBIRT) Model. In the proposed study, staff at community sites will deliver a tailored SBIRT model for people seeking to get pregnant as our "Project IMPACT intervention". SBIRT was originally developed as a public health model designed to provide universal screening, secondary prevention (detecting risky or hazardous substance use before the onset of abuse or dependence), early intervention, and treatment for people who have problematic or hazardous alcohol problems within primary care and other health care settings. Morehouse School of Medicine (MSM) has adapted this SBIRT model for people who are seeking to get pregnant to assess their risks and provide early intervention to at-risk people of reproductive age who want to get pregnant. Brief preconception counseling interventions addressing multiple behavioral risk factors have been found to be effective in prior studies.

Primary outcome measure

  • Implementation [ Time Frame: 6 months ]
  • Effectiveness [ Time Frame: baseline, 3 months, 6 months ]
  • Effectiveness [ Time Frame: baseline, 3 months, 6 months ]

Central Contacts and Locations

Central contacts

Madison Haiman, PhD

470-670-7071mhaiman@msm.edu

Adenike McDonald, MPH

470-670-6397projectimpactteam@msm.edu

Locations

Morehouse School of Medicine

Recruiting

Atlanta, Georgia, United States, 30310

More Information

Sponsor

Morehouse School of Medicine

Last update posted

Jun 15, 2025

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Morehouse School of Medicine on 2025-06-15.