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

Sponsor

Ohio State University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03416010

Collaborator

National Institutes of Health (NIH) (NIH), New York University (Other), Jacobi Medical Center (Other), Boston College (Other), University of Arizona (Other), Drexel University (Other), National Institute on Minority Health and Health Disparities (NIMHD) (NIH), University of South Florida (Other)

300

Enrollment

Locations

Arms

62.9

Anticipated Duration (Months)

100

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Emotional Disturbances Depression Pregnancy Late Post-Partum Depression Anxiety Nutritional Deficiency	Behavioral: COPE-P	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

longitudinal, randomized block RCT with repeated measureslongitudinal, randomized block RCT with repeated measures

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Mar 5, 2018

Anticipated Primary Completion Date :

May 31, 2022

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control 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
Active Comparator: 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.	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.

Arm

Intervention/Treatment

No Intervention: Control

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

Active Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

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

birth weight [T2= 6-8 week postpartum visit]
record of birth weight as recorded in patient's medical file
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 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
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
Mode of Delivery [T2= 6-8 week postpartum visit]
(C/S, Vaginal, Forceps/Vacuum)
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
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
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 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
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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jacobi Medical Center	Bronx	New York	United States	10461
2	OSU Total Health and Wellness	Columbus	Ohio	United States	43210
3	OSUWMC OB/GYN Clinic	Columbus	Ohio	United States	43210

Sponsors and Collaborators

Ohio State University
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

Investigators

Principal Investigator: Bernadette Melnyk, PhD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bernadette Melnyk, Dean and Professor, College of Nursing Vice President of Health Promotion, Professor of Pediatrics and Psychiatry, College of Medicine, Ohio State University

ClinicalTrials.gov Identifier:

NCT03416010

Other Study ID Numbers:

2017B0425
1R01MD012770-01A1

First Posted:

Jan 30, 2018

Last Update Posted:

May 3, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bernadette Melnyk, Dean and Professor, College of Nursing Vice President of Health Promotion, Professor of Pediatrics and Psychiatry, College of Medicine, Ohio State University

emotional distress pregnancy disparities minority depression

Additional relevant MeSH terms:

Depression, Postpartum

Study Results

No Results Posted as of May 3, 2022