Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women

Not Applicable

Active, not recruiting

• Conditions: Anxiety; Depression; Pregnancy Late; Post-Partum Depression; Nutritional Deficiency; Emotional Disturbances
• Interventions: Behavioral: COPE-P

• Registration Number: NCT03416010
• Lead Sponsor: Ohio State University

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-30
• Study Start: 2018-03-05
• Primary Completion: 2023-04-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-22
• Study Completion: 2025-04-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 299

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	COPE-P	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.

Primary Outcome Measures

Name	Time	Method
Change is being assessed for an increase or decrease in self-reported healthy lifestyle beliefs	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit	Healthy Lifestyle Beliefs Scale survey will be administered at each of the in-person meetings. This scale taps beliefs about various facets of maintaining a healthy lifestyle. This 16-item is scored on a five point Likert-type scale that ranging from 1 strongly disagree to 5 strongly agree. The higher the score the higher the beliefs of maintaining a healthy lifestyle.
Change is being assessed for an increase or decrease in self-reported Anxiety level	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit	The Generalized Anxiety Scale (GAD-7) is a 7-item survey which measures anxiety will be administered at each of the in-person meetings. The GAD-7 is a 7-item, 4-point Likert-type scale ranging from (0) Not at all to (3). Scores range from 0 to 21, with higher scores indicating greater functional impairment related to the patient's experience of anxiety. A score greater than or equal to 10 indicates moderate and higher anxiety and will be used in this study,
Change is being assessed for an increase or decrease in self-reported stress	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit	The Perceived Stress Scale (PSS) is a scale measuring stress will be administered at each of the in-person meetings. This scale is a standardized measure of global stress designed to elicit the degree to which respondents find their lives unpredictable, uncontrollable, and overloading (three central components of stress). A score of 20 or greater is the high stress cut-off and will be used in this study.
Change is being assessed for an Increase or decrease in self-reported healthy lifestyle behaviors	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit	The Healthy Lifestyle Behaviors Scale survey will be administered at each of the in-person meetings. Participants respond to each of the 15 items (e.g., I exercised regularly; I talked about my worries) on a 5-point Likert-type scale that ranges from 1 strongly disagree to 5 strongly agree. The higher the score the higher the healthy lifestyle behaviors are practiced.
Change is being assessed for an increase or decrease in self-reported depressive symptoms	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit	The Edinburgh Postnatal Depression Scale (EPDS) is a scale measuring depressive symptoms will be administered at each of the in-person meetings. The Edinburgh Postnatal Depression Scale is a 10 item self-report perinatal depression questionnaire. The scale asks participants to describe how they have felt in the previous week. Unlike other depression screening tools, the EPDS excludes questions regarding somatic symptoms of pregnancy and has been found to be equivalent to a structured interview in determining prevalence of depression. Scores range from 0-30 with higher scores signifying higher severity of depressive symptoms. A cut-off score of 10 on the EPDS will be used in this study to indicate moderate depressive symptoms.

Secondary Outcome Measures

Name	Time	Method
Breastfeeding initiation time	T2= 6-8 week postpartum visit and T3 = at 6 month well baby visit	DPI Form: survey administered at meeting 3 and meeting 4
Mode of Delivery	T2= 6-8 week postpartum visit	(C/S, Vaginal, Forceps/Vacuum)
Nutritional intake	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit	24 Hour Nutrition Log/Food Processor: survey will be administered at each of the in-person meetings
Level of Exercise	T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit	Fitbit Flex 2 Accelerometer report data: data from Fitbit Flex 2 report will be collected at each of the in-person meetings
Program Evaluation	T1=31 gestational weeks; T3=6 month well-baby visit	Separate forms for intervention and attention control that address qualitative data regarding participant experience in study program as well as delivery method, virtually or in-person
Participant Body Mass Index (BMI)	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit	derived calculation from weight and height values reported at each of the in person meetings
birth weight	T2= 6-8 week postpartum visit	record of birth weight as recorded in patient's medical file
COPE-P Acceptability	T1 = 31 gestational weeks, T2= 6-8 week postpartum visit	Index (COPE-P group): Survey administered at meeting 2 and meeting 3
Gestational age at birth	T2= 6-8 week postpartum visit	Gestational age at birth will be collected as reported on patient's medical chart
Participant height	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit	height in feet and inches will be recorded at each of the in person meetings
Group Prenatal Care Acceptability	T1=31 gestational weeks	Survey addressing participant responses to prenatal care in a group setting
Mode of Delivery: C-section, forceps/vacuum, vaginal	T2= 6-8 week postpartum visit	record of mode of delivery as recorded in patient's medical file
breastfeeding duration	T2= 6-8 week postpartum visit and T3 = at 6 month well baby visit	DPI Form: survey administered at meeting 3 and meeting 4
Participant weight	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit	weight in pounds will be collected and reported at each of the in person meetings

Trial Locations

Locations (3)

OSU Total Health and Wellness; 🇺🇸 Columbus, Ohio, United States

OSUWMC OB/GYN Clinic; 🇺🇸 Columbus, Ohio, United States

Jacobi Medical Center; 🇺🇸 Bronx, New York, United States