Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women

NCT03416010 | Completed Results DMC

• 2 other identifiers: 2017B04251R01MD012770-01A1
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 3

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.

Conditions

Emotional Disturbances; Depression; Pregnancy Late; Post-Partum Depression; Anxiety; Nutritional Deficiency

Keywords

emotional distress pregnancy disparities minority depression

Outcome Measures

Primary Outcomes (5)

• Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3

  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

  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

  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

  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

  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 Outcomes (14)

• Birth Weight

  T2= 6-8 week postpartum visit

• Breastfeeding Initiation

  T2= 6-8 week postpartum visit

• Breastfeeding Duration

  T3 = at 6 month well baby visit

• Mode of Delivery

  T2= 6-8 week postpartum visit

• Nutritional Intake

  Timepoint 0 (<19 weeks gestation), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit

Study Arms (2)

Control

NO INTERVENTION

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

Intervention

ACTIVE COMPARATOR

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

Interventions

COPE-P BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnancy is only experienced by women so only women are included as study participants.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead
• National Institutes of Health (NIH): collaborator
• New York University: collaborator
• Jacobi Medical Center: collaborator
• Boston College: collaborator
• University of Arizona: collaborator
• Drexel University: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• University of South Florida: collaborator

Study Sites (3)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

OSU Total Health and Wellness

Columbus, Ohio, 43210, United States

Location

OSUWMC OB/GYN Clinic

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Gennaro S, Melnyk BM, Szalacha LA, Gibeau AM, Hoying J, O'Connor CM, Cooper AR, Aviles MM. Effects of Two Group Prenatal Care Interventions on Mental Health: An RCT. Am J Prev Med. 2024 May;66(5):797-808. doi: 10.1016/j.amepre.2024.01.005. Epub 2024 Feb 5.

  PMID: 38323949 DERIVED

MeSH Terms

Conditions

Affective Symptoms; Depression; Depression, Postpartum; Anxiety Disorders; Malnutrition

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Nutrition Disorders; Nutritional and Metabolic Diseases

Limitations and Caveats

The COVID-19 pandemic impacted delivery of care requiring changes to methodology and impacting recruitment. Virtual sessions and timepoints were utilized, limiting data collection (e.g. measured weight vs participant report), the efficacy of Fitbit use (less frequent clinic visits resulted in less reminders to charge devices and lack of syncing at in-person sessions). Recruitment target was not met and attrition exceeded expectations leading to fewer participants analyzed than expected.

Results Point of Contact

• Title: Dr. Bernadette Melnyk
• Organization: The Ohio State University

melnyk.15@osu.edu

6142924844

Study Officials

• Bernadette Melnyk, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean and Professor, College of Nursing Vice President of Health Promotion, Professor of Pediatrics and Psychiatry, College of Medicine

Model Details: longitudinal, randomized block RCT with repeated measures

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: January 30, 2018
• Study Start: March 5, 2018
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: March 18, 2025
• Results First Posted: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)