Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Depression, Anxiety, Emotional Disturbances, Pregnancy Late, Post-Partum Depression, Nutritional Deficiency

Intervention / Treatment
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* Behavioral: COPE-P


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: longitudinal, randomized block RCT with repeated measures
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emotional distress pregnancy disparities minority depression