Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women

Summary

The overall purpose of this application is to evaluate the efficacy of an intervention designed to decrease health disparities in pregnant, emotionally distressed, minority women. This randomized controlled trial will test a six session (spaced over 18 weeks) cognitive behavioral skills building (CBSB) prenatal care intervention (specifically designed and based on prior research for pregnant minority women experiencing emotional distress) at three sites (Jacobi Medical Center, New York City and The Ohio State University Total Health and Wellness Clinic, and The Ohio State University Wexner Medical Center OB/GYN Columbus, Ohio.

Conditions

• Emotional Disturbances
• Depression
• Pregnancy Late
• Post-Partum Depression
• Anxiety
• Nutritional Deficiency

Interventions

BEHAVIORAL

COPE-P

Session 1 ABCs (A=Antecedent or Activator event, B=Belief that follows the event, C=Consequence: how you feel and how you behave). Session 2 self-esteem and positive self-talk, including ways to build self-esteem and the group provides examples of how to change unhealthy habits into healthy ones. Session 3 stress/coping during pregnancy. Physical and emotional responses to stress are discussed along with healthy snacking and healthy ways to cope with typical stresses. Session 4 planning, goal setting and the 4-step problem solving process. Session 5 dealing with emotions in healthy ways through positive thinking and effective communication. Session 6 coping with stressful situations encountered during pregnancy while continuing to reinforce the thinking-feeling-behaving triangle.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• New York University

  collaborator OTHER

• Jacobi Medical Center

  collaborator OTHER

• Boston College

  collaborator OTHER

• University of Arizona

  collaborator OTHER

• Drexel University

  collaborator OTHER

• National Institute on Minority Health and Health Disparities (NIMHD)

  collaborator NIH

• University of South Florida

  collaborator OTHER

• Ohio State University

  lead OTHER

Principal Investigators

• Bernadette Melnyk, PhD · Ohio State University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-03-05

Primary Completion

2023-04-20

Completion

2023-04-20

Countries

• United States

Study Locations