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

Primary Purpose

Emotional Disturbances, Depression, Pregnancy Late

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COPE-P
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Emotional Disturbances focused on measuring emotional distress pregnancy disparities minority depression

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts 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.

Sites / Locations

  • Jacobi Medical Center
  • OSU Total Health and Wellness
  • OSUWMC OB/GYN Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Intervention

Arm 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

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.

Outcomes

Primary Outcome Measures

Change is being assessed for an increase or decrease in self-reported healthy lifestyle beliefs
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
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
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
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
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

birth weight
record of birth weight as recorded in patient's medical file
Mode of Delivery: C-section, forceps/vacuum, vaginal
record of mode of delivery as recorded in patient's medical file
Breastfeeding initiation time
DPI Form: survey administered at meeting 3 and meeting 4
breastfeeding duration
DPI Form: survey administered at meeting 3 and meeting 4
Mode of Delivery
(C/S, Vaginal, Forceps/Vacuum)
COPE-P Acceptability
Index (COPE-P group): Survey administered at meeting 2 and meeting 3
Nutritional intake
24 Hour Nutrition Log/Food Processor: survey will be administered at each of the in-person meetings
Level of Exercise
Fitbit Flex 2 Accelerometer report data: data from Fitbit Flex 2 report will be collected at each of the in-person meetings
Gestational age at birth
Gestational age at birth will be collected as reported on patient's medical chart
Participant weight
weight in pounds will be collected and reported at each of the in person meetings
Participant Body Mass Index (BMI)
derived calculation from weight and height values reported at each of the in person meetings
Participant height
height in feet and inches will be recorded at each of the in person meetings
Group Prenatal Care Acceptability
Survey addressing participant responses to prenatal care in a group setting
Program Evaluation
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

Full Information

First Posted
November 14, 2017
Last Updated
August 2, 2023
Sponsor
Ohio State University
Collaborators
National Institutes of Health (NIH), New York University, Jacobi Medical Center, Boston College, University of Arizona, Drexel University, National Institute on Minority Health and Health Disparities (NIMHD), University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT03416010
Brief Title
Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women
Acronym
A-RCT
Official Title
Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women: A-RCT
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
April 20, 2023 (Actual)
Study Completion Date
April 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
National Institutes of Health (NIH), New York University, Jacobi Medical Center, Boston College, University of Arizona, Drexel University, National Institute on Minority Health and Health Disparities (NIMHD), University of South Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Disturbances, Depression, Pregnancy Late, Post-Partum Depression, Anxiety, Nutritional Deficiency
Keywords
emotional distress pregnancy disparities minority depression

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
longitudinal, randomized block RCT with repeated measures
Masking
None (Open Label)
Allocation
Randomized
Enrollment
299 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm 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
Arm Title
Intervention
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
COPE-P
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change is being assessed for an increase or decrease in self-reported healthy lifestyle beliefs
Description
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.
Time Frame
Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Title
Change is being assessed for an increase or decrease in self-reported Anxiety level
Description
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,
Time Frame
Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Title
Change is being assessed for an increase or decrease in self-reported stress
Description
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.
Time Frame
Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Title
Change is being assessed for an Increase or decrease in self-reported healthy lifestyle behaviors
Description
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.
Time Frame
Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Title
Change is being assessed for an increase or decrease in self-reported depressive symptoms
Description
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.
Time Frame
Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Secondary Outcome Measure Information:
Title
birth weight
Description
record of birth weight as recorded in patient's medical file
Time Frame
T2= 6-8 week postpartum visit
Title
Mode of Delivery: C-section, forceps/vacuum, vaginal
Description
record of mode of delivery as recorded in patient's medical file
Time Frame
T2= 6-8 week postpartum visit
Title
Breastfeeding initiation time
Description
DPI Form: survey administered at meeting 3 and meeting 4
Time Frame
T2= 6-8 week postpartum visit and T3 = at 6 month well baby visit
Title
breastfeeding duration
Description
DPI Form: survey administered at meeting 3 and meeting 4
Time Frame
T2= 6-8 week postpartum visit and T3 = at 6 month well baby visit
Title
Mode of Delivery
Description
(C/S, Vaginal, Forceps/Vacuum)
Time Frame
T2= 6-8 week postpartum visit
Title
COPE-P Acceptability
Description
Index (COPE-P group): Survey administered at meeting 2 and meeting 3
Time Frame
T1 = 31 gestational weeks, T2= 6-8 week postpartum visit
Title
Nutritional intake
Description
24 Hour Nutrition Log/Food Processor: survey will be administered at each of the in-person meetings
Time Frame
Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Title
Level of Exercise
Description
Fitbit Flex 2 Accelerometer report data: data from Fitbit Flex 2 report will be collected at each of the in-person meetings
Time Frame
T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Title
Gestational age at birth
Description
Gestational age at birth will be collected as reported on patient's medical chart
Time Frame
T2= 6-8 week postpartum visit
Title
Participant weight
Description
weight in pounds will be collected and reported at each of the in person meetings
Time Frame
Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Title
Participant Body Mass Index (BMI)
Description
derived calculation from weight and height values reported at each of the in person meetings
Time Frame
Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Title
Participant height
Description
height in feet and inches will be recorded at each of the in person meetings
Time Frame
Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Title
Group Prenatal Care Acceptability
Description
Survey addressing participant responses to prenatal care in a group setting
Time Frame
T1=31 gestational weeks
Title
Program Evaluation
Description
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
Time Frame
T1=31 gestational weeks; T3=6 month well-baby visit

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnancy is only experienced by women so only women are included as study participants.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernadette Melnyk, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
OSU Total Health and Wellness
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
OSUWMC OB/GYN Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women

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