Recruiting

BETTER

Sponsor:

Ohio State University

Code:

NCT06261398

Conditions

Pregnancy

Maternal Anemia

Pre-Term Birth

Hypertensive Disorders

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BETTER: motivational interviewing and text messaging

Standard of care

Study Details

Brief summary:

This is a pragmatic randomized control trial to evaluate the BETTER intervention compared to standard obstetrical care (control) to determine whether it helps to reduce maternal anemia and other adverse pregnancy outcomes. The BETTER intervention includes one motivational interviewing session and bi-weekly text messages to encourage patients to connect with resources that address their social needs, including housing, food, and transportation. Quantitative data will be used to study participant outcomes, including surveys, and electronic health record data.

Conditions

Pregnancy

Maternal Anemia

Pre-Term Birth

Hypertensive Disorders

Study ID

NCT06261398

Start date

Feb 26, 2024

Status verified date

Jun, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Less than 20 weeks and 6 days pregnant upon enrollment
  • At least 18 years of age
  • Receiving obstetric care at OSU McCampbell Hall or OSU Outpatient Care East
  • Singleton pregnancy and fetus with a heartbeat
  • English speaking
  • Able to receive text messages

Exclusion Criteria

  • Has a significant medical condition (eg sickle cell disease) that is a cause of anemia
  • Has a plan for transfusion during pregnancy

Study Design

Enrollment

550 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: BETTER Intervention

Patients in the intervention group will receive one motivational interviewing session immediately after randomization and biweekly text messages until delivery to encourage them to connect to resources to address their social needs.

active comparator: Standard of care

No motivational interviewing or text messages will be provided.

Interventions

BETTER: motivational interviewing and text messaging

Motivational interviewing to encourage individuals to address their social needs and engage with text messages that allow individuals to connect to their care team, a local organization that can help them address their social needs, and/or a resource that enables them to find help to address their needs based on their zip code.

Standard of care

No motivational interviewing or text messages will be provided.

Primary outcome measure

  • Incidence of maternal anemia [ Time Frame: At delivery ]

Central Contacts and Locations

Central contacts

Ann McAlearney, ScD, MS

614-293-3716Ann.McAlearney@osumc.edu

Nicole Thomas, PhD

614-247-6228Nicole.Thomas3@osumc.edu

Locations

The Ohio State University Outpatient Care East

Recruiting

Columbus, Ohio, United States, 43203

Contacts

William Grobman, MD, MBA

(614) 293-4929William.Grobman@osumc.edu

Anna Bartholomew, BSN, RN, MPH

614-685-3229Anna.Bartholomew@osumc.edu

McCampbell Hall

Recruiting

Columbus, Ohio, United States, 43210

Contacts

William Grobman, MD, MBA

614-293-4929William.Grobman@osumc.edu

Anna Bartholomew, BSN, RN, MPH

614-685-3229Anna.Bartholomew@osumc.edu

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Recruiting

Columbus, Ohio, United States, 43210

Contacts

William Grobman, MD, MBA

(614) 293-4929William.Grobman@osumc.edu

Anna Bartholomew, BSN, RN, MPH

614-685-3229Anna.Bartholomew@osumc.edu

More Information

Sponsor

Ohio State University

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

  • Social Determinants of Health (SDoH)
  • Pregnancy
  • Patient portals
  • Patient engagement
  • Disparities

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-06-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.