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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Anxiety; Emotional Disturbances; Nutritional Deficiency; Pregnancy Late; Post-Partum Depression
• Intervention / Treatment: Behavioral: COPE-P

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 Type: Interventional
• Enrollment (Actual): 299
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Jacobi Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • OSU Total Health and Wellness
    • Columbus, Ohio, United States, 43210
      • OSUWMC OB/GYN Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
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,	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
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.	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
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.	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
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.	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
birth weight	record of birth weight as recorded in patient's medical file	T2= 6-8 week postpartum visit
Mode of Delivery: C-section, forceps/vacuum, vaginal	record of mode of delivery as recorded in patient's medical file	T2= 6-8 week postpartum visit
Breastfeeding initiation time	DPI Form: survey administered at meeting 3 and meeting 4	T2= 6-8 week postpartum visit and T3 = at 6 month well baby visit
breastfeeding duration	DPI Form: survey administered at meeting 3 and meeting 4	T2= 6-8 week postpartum visit and T3 = at 6 month well baby visit
Mode of Delivery	(C/S, Vaginal, Forceps/Vacuum)	T2= 6-8 week postpartum visit
COPE-P Acceptability	Index (COPE-P group): Survey administered at meeting 2 and meeting 3	T1 = 31 gestational weeks, T2= 6-8 week postpartum visit
Nutritional intake	24 Hour Nutrition Log/Food Processor: survey will be administered at each of the in-person meetings	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
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	T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Gestational age at birth	Gestational age at birth will be collected as reported on patient's medical chart	T2= 6-8 week postpartum visit
Participant weight	weight in pounds will be collected and reported at each of the in person meetings	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Participant Body Mass Index (BMI)	derived calculation from weight and height values reported at each of the in person meetings	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Participant height	height in feet and inches will be recorded at each of the in person meetings	Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Group Prenatal Care Acceptability	Survey addressing participant responses to prenatal care in a group setting	T1=31 gestational weeks
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	T1=31 gestational weeks; T3=6 month well-baby visit

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: University of South Florida; New York University; National Institute on Minority Health and Health Disparities (NIMHD); National Institutes of Health (NIH); University of Arizona; Jacobi Medical Center; Drexel University; Boston College
• Investigators: Principal Investigator: Bernadette Melnyk, PhD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2018
• Primary Completion (Actual): April 20, 2023
• Study Completion (Estimated): April 20, 2024

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 30, 2018

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: emotional distress pregnancy disparities minority depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Nutrition Disorders; Pregnancy Complications; Puerperal Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depression; Depressive Disorder; Depression, Postpartum; Malnutrition; Affective Symptoms
• Other Study ID Numbers: 2017B0425; 1R01MD012770-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No