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

March 2, 2025 updated by: Bernadette Melnyk, Ohio State University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
299

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3
Time Frame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child 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 minimum score is 16 and the maximum score is 80. The higher the score the higher the beliefs of maintaining a healthy lifestyle.
Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
Change in Self-reported Anxiety Level From Timepoint 0 to Timepoint 3
Time Frame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child 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,
Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
Change in Self-reported Healthy Lifestyle Behaviors From Timepoint 0 to Timepoint 3
Time Frame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child 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 minimum score is 15 and the maximum score is 75. The higher the score the higher the healthy lifestyle behaviors are practiced.
Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
Change in Self-reported Depressive Symptoms From Timepoint 0 to Timepoint 3
Time Frame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child 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.
Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
Change Self-reported Stress at Timepoint 0 to Timepoint 3
Time Frame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child 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). The minimum score is 0 and the maximum score is 40. A higher score is correlated with a higher amount of stress. A score of 20 or greater is the high stress cut-off and will be used in this study.
Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mode of Delivery
Time Frame: T2= 6-8 week postpartum visit
(C/S, Vaginal, Forceps/Vacuum)
T2= 6-8 week postpartum visit
Level of Exercise
Time Frame: 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
T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Participant Body Mass Index (BMI)
Time Frame: 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
Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Birth Weight
Time Frame: T2= 6-8 week postpartum visit
record of birth weight as recorded in patient's medical file
T2= 6-8 week postpartum visit
Breastfeeding Initiation
Time Frame: T2= 6-8 week postpartum visit
Initiation of breastfeeding according to self-report at Timepoint 2: "Did you ever breastfeed or try to breastfeed your baby?". Responses below indicated number of participants that responded "yes" to this question.
T2= 6-8 week postpartum visit
Breastfeeding Duration
Time Frame: T3 = at 6 month well baby visit
Self-reported maintenance of breastfeeding at approximately 6 months postpartum, inclusive of participants that responded both breastfeeding only and combined breast and bottle feeding (formula vs breastmilk not specified in question to participants).
T3 = at 6 month well baby visit
Nutritional Intake
Time Frame: Timepoint 0 (<19 weeks gestation), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Nutrition behaviors as reflected in response to likert scale-type question "I eat fresh fruits and vegetable snacks". Reponses included Strongly Disagree (1), Disagree (2), Neither Agree Nor Disagree (3), Agree (4), Strongly Agree (5).
Timepoint 0 (<19 weeks gestation), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Gestational Age at Birth
Time Frame: T2= 6-8 week postpartum visit
Gestational age at birth will be collected as reported on patient's medical chart
T2= 6-8 week postpartum visit
Weight
Time Frame: Timepoint 0 (<19 weeks gestation)
weight in pounds
Timepoint 0 (<19 weeks gestation)
Participant Height
Time Frame: Timepoint 0 (Baseline at screening)
height in feet and inches will be recorded at each of the in person meetings
Timepoint 0 (Baseline at screening)
Group Prenatal Care Acceptability
Time Frame: T1=31 gestational weeks

Survey addressing participant responses to prenatal care in a group setting with 12 Likert scale-type responses: strongly disagree, disagree, neutral, agree, and strongly agree. Participants were also provided a free text box.

Reported are responses to the question "I would recommend group prenatal care to a friend".
T1=31 gestational weeks
Program Evaluation: Delivery Method
Time Frame: Timepoint 3, approximately 6 months postpartum
Separate forms for intervention and attention control that collected data regarding participant experience in study program as well as delivery method, virtually or in-person. Delivery method was ranked by participants 1-4 for preference: 1:1 in person, 1:1 by telehealth, in small group in person, in small group by telehealth.
Timepoint 3, approximately 6 months postpartum
COPE-P Acceptability
Time Frame: Timepoint 2 (6 to 8 weeks postpartum)
Survey administered with likert-style scale exploring participant satisfaction with different aspects of COPE-P. Participant score range 1 (Strongly Disagree) - 5 (Strongly Agree). Minimum score of 21, maximum of 105. High scores indicate higher satisfaction with the COPE-P program and its elements.
Timepoint 2 (6 to 8 weeks postpartum)
Program Evaluation
Time Frame: Timepoint 3, approximately 6 months postpartum
Separate forms for intervention and attention control that collected data regarding participant experience in study program as well as delivery method, virtually or in-person. Delivery method was ranked by participants 1-4 for preference: 1:1 in person, 1:1 by telehealth, in small group in person, in small group by telehealth.
Timepoint 3, approximately 6 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bernadette Melnyk, PhD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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