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Completed

NCT Number: NCT03416010

Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women

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.

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Key information

Conditions

Emotional Disturbances Affective Symptoms Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Malnutrition Mental Disorders Mood Disorders Nutrition Disorders Nutritional Deficiency Nutritional and Metabolic Diseases Post-partum Depression Pregnancy Complications Pregnancy Late Puerperal Disorders Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jacobi Medical Center, The Bronx, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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,

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Birth Weight

    Time frame: T2= 6-8 week postpartum visit

    record of birth weight as recorded in patient's medical file

  2. 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.

  3. 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).

  4. Mode of Delivery

    Time frame: T2= 6-8 week postpartum visit

    (C/S, Vaginal, Forceps/Vacuum)

  5. 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).

  6. 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

  7. 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

  8. Weight

    Time frame: Timepoint 0 (<19 weeks gestation)

    weight in pounds

  9. 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

  10. Participant Height

    Time frame: Timepoint 0 (Baseline at screening)

    height in feet and inches will be recorded at each of the in person meetings

  11. 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".

  12. 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.

  13. 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.

  14. 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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: A-RCT

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jan 30, 2018
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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