NCT03416010

Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women

Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women: A-RCT

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 299 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

A randomized controlled trial will test a cognitive behavioral skills building intervention (COPE-P) in Black and Hispanic women experiencing emotional distress in two sites (New York and Ohio) to determine if the intervention leads to better health behaviors, better psychosocial health (anxiety, stress, and depressive symptoms), and improved birth and post-natal outcomes in women experiencing emotional distress. Developing scalable prenatal interventions designed to improve birth outcomes as well as maternal physical and psychosocial health is essential to decrease health disparities in pregnant minority women.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-03-05
• Primary completion: 2023-04-20
• Completion: 2023-04-20
• First posted: 2018-01-30
• Last updated: 2025-03-18
• Results posted: 2025-03-18

Locations

3 sites across 1 country: United States