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

The Ohio State University

Status: Active, not recruiting

Conditions: Emotional Disturbances; Post-Partum Depression; Nutritional Deficiency; Depression; Anxiety; Pregnancy Late

Treatments: Behavioral: COPE-P

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03416010

2017B0425

1R01MD012770-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 299 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant women between the ages of 18-40 years old
• Pregnant women experiencing an uncomplicated singleton pregnancy of less than 19 weeks
• Self-identified as either Black or Hispanic
• Able to read and speak English.
• The child participants born to the participants will have their record accessed for data collection.

Exclusion criteria

• Women with chronic medical conditions (e.g., hypertension, or diabetes), are currently receiving treatment or therapy for a psychiatric diagnosis, or have participated in this study with a prior pregnancy.
• Women with obstetrical complications, such as preeclampsia, gestational diabetes, or fetal abnormalities.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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299 participants in 2 patient groups

Control

No Intervention group

Description:

In addition to standard prenatal care the PregnancyPlus attention control group for 6 weeks will receive 1.5 hours of ACOG-designed patient education pamphlets. Material will include prenatal and post-partum education.. Dr. Gennaro will conduct the training of the attention control group midwives. The same protocol for assessing fidelity for COPE-P also will be used for assessing fidelity to the attention control intervention

Intervention

Active Comparator group

Description:

In addition to standard prenatal care the COPE-P intervention group will also receive 1.5 hours each week for 6 weeks the cognitive-behavior skills building program driven by CBT as the theoretical framework by health care providers trained in COPE-P by Dr. Melnyk. The content of the COPE program is driven by the literature review, the theoretical framework, previous studies of COPE interventions with mothers of preterm infants and prior work with pregnant minority women by our team.

Treatment:

Behavioral: COPE-P