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.
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
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
299
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.
Jacobi Medical Center
The Bronx, New York, United States
OSU Total Health and Wellness
Columbus, Ohio, United States
OSUWMC OB/GYN Clinic
Columbus, Ohio, United States
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.
Time frame: 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,
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
Birth Weight
record of birth weight as recorded in patient's medical file
Time frame: T2= 6-8 week postpartum visit
Breastfeeding Initiation
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.
Time frame: T2= 6-8 week postpartum visit
Breastfeeding Duration
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).
Time frame: T3 = at 6 month well baby visit
Mode of Delivery
(C/S, Vaginal, Forceps/Vacuum)
Time frame: T2= 6-8 week postpartum visit
Nutritional Intake
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).
Time frame: Timepoint 0 (<19 weeks gestation), 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
Time frame: 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
Time frame: T2= 6-8 week postpartum visit
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Weight
weight in pounds
Time frame: Timepoint 0 (<19 weeks gestation)
Participant Body Mass Index (BMI)
derived calculation from weight and height values reported at each of the in person meetings
Time frame: 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
Time frame: Timepoint 0 (Baseline at screening)
Group Prenatal Care Acceptability
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".
Time frame: T1=31 gestational weeks
Program Evaluation: Delivery Method
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.
Time frame: Timepoint 3, approximately 6 months postpartum
COPE-P Acceptability
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.
Time frame: Timepoint 2 (6 to 8 weeks postpartum)
Program Evaluation
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.
Time frame: Timepoint 3, approximately 6 months postpartum