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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MD012770-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| New York University | OTHER |
| Jacobi Medical Center | OTHER |
| Boston College |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Birth Weight | record of birth weight as recorded in patient's medical file | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy is only experienced by women so only women are included as study participants.
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| Name | Affiliation | Role |
|---|---|---|
| Bernadette Melnyk, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacobi Medical Center | The Bronx | New York | 10461 | United States | ||
| OSU Total Health and Wellness |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42338028 | Derived | Melnyk BM, Gennaro S, Szalacha LA, Gibeau AM, Hoying J, O'Connor CM, Cooper A, Aviles MM. Improving Postpartum Mental Health and Healthy Lifestyle Behaviors in Women of Color Who Are Pregnant and Experiencing Depression, Anxiety, and Stress Through Group Prenatal Care: A Randomized Controlled Trial. J Midwifery Womens Health. 2026 Jun 23. doi: 10.1111/jmwh.70154. Online ahead of print. | |
| 38323949 | Derived | 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. |
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8,335 participant records were prescreened for eligibility. 6,842 did not meet inclusion criteria. 771 declined to participate. 423 participants consented to participate in the study but were ineligible after completing screening questionnaires (GAD-7, PSS, and EPDS).
Participant recruitment was initiated March 5, 2018, at two medical clinic sites in urban clinics in two states. A third medical clinic site was added to support recruitment in 2019. Recruitment closed April 11, 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Timepoint 0 (<19 Weeks Gestation) |
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| Timepoint 1 (31 Gestational Weeks) |
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| Timepoint 2 (6 Weeks Postpartum) |
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| Timepoint 3 (6 Months Postpartum) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants who completed data collection at respective timepoints. | Posted | Mean | Standard Error | units on a scale | Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit) |
|
From baseline (<19 weeks gestation) to collection of Timepoint 3, approximately 6 months postpartum.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide Attempt | Psychiatric disorders | Systematic Assessment | Any attempt at self-harm by a participant |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Preterm Birth | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Delivery prior to 37 weeks gestation |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bernadette Melnyk | The Ohio State University | 6142924844 | melnyk.15@osu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Ohio Study Protocol | Nov 2, 2021 | Jan 6, 2025 | Prot_SAP_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: New York Study Protocol | Sep 29, 2021 | Jan 6, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Ohio Informed Consent Form | Nov 2, 2021 | Jan 6, 2025 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: New York Informed Consent Form | Sep 29, 2021 | Jan 6, 2025 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D000342 | Affective Symptoms |
| D003863 | Depression |
| D019052 | Depression, Postpartum |
| D001008 | Anxiety Disorders |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
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| OTHER |
| University of Arizona | OTHER |
| Drexel University | OTHER |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
| University of South Florida | OTHER |
longitudinal, randomized block RCT with repeated measures
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|
| 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) |
| 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). | T3 = at 6 month well baby visit |
| Mode of Delivery | (C/S, Vaginal, Forceps/Vacuum) | 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). | 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 | 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 |
| Weight | weight in pounds | 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 | 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) |
| 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". | 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. | 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. | 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. | Timepoint 3, approximately 6 months postpartum |
| Columbus |
| Ohio |
| 43210 |
| United States |
| OSUWMC OB/GYN Clinic | Columbus | Ohio | 43210 | United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Enrolled in School | Count of Participants | Participants |
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| OG001 | 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. 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. |
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| Primary | 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, | All participants who completed respective timepoints. | Posted | Mean | Standard Error | units on a scale | Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit) |
|
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|
|
| Primary | 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. | All participants who completed data collection at respective timepoints. | Posted | Mean | Standard Error | units on a scale | Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit) |
|
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|
|
| Primary | 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. | All participants completing data collection at respective timepoints. | Posted | Mean | Standard Error | units on a scale | Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit) |
|
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|
|
| Primary | 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. | All participants completing data collection at respective timepoints. | Posted | Mean | Standard Error | units on a scale | Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit) |
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| Secondary | Birth Weight | record of birth weight as recorded in patient's medical file | Infant weight was not available for all participants who completed timepoint (i.e. delivered at outside institution) | Posted | Mean | Standard Deviation | grams | T2= 6-8 week postpartum visit |
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| Secondary | 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. | Number of participants that completed Timepoint 2 | Posted | Count of Participants | Participants | T2= 6-8 week postpartum visit |
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| Secondary | 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). | Number of participants who completed Timepoint 3 | Posted | Count of Participants | Participants | T3 = at 6 month well baby visit |
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| Secondary | Mode of Delivery | (C/S, Vaginal, Forceps/Vacuum) | Delivery mode not available for all participants who completed timepoint (i.e. delivered at outside institution) | Posted | Count of Participants | Participants | T2= 6-8 week postpartum visit |
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| Secondary | 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). | Each row represents a study timepoint. Number analyzed in the number of participants who completed the respective timepoint. | Posted | Mean | Standard Error | units on a scale | Timepoint 0 (<19 weeks gestation), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit |
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| Secondary | 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 | Fitbit data was not analyzed. Prior to COVID-19, participant adherence to Fitbit use was low (reported difficulty with charging, losing Fitbit, not bringing to study sessions). With the onset of the COVID-19 pandemic, participants were not able to bring Fitbits to in-person appointments to complete syncing. | Posted | T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit |
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| Secondary | Gestational Age at Birth | Gestational age at birth will be collected as reported on patient's medical chart | Gestational age was not available for all participants who completed timepoint (i.e. delivered at outside institution) | Posted | Mean | Standard Deviation | weeks | T2= 6-8 week postpartum visit |
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| Secondary | Weight | weight in pounds | Posted | Mean | Standard Deviation | pounds | Timepoint 0 (<19 weeks gestation) |
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| Secondary | Participant Body Mass Index (BMI) | derived calculation from weight and height values reported at each of the in person meetings | Number analyzed in each row reflects the number completed at respective timepoints. This data is missing due to remote data collection lacking weight measurement devices (COVID-19). | Posted | Mean | Standard Deviation | kg/m^2 | Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit |
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| Secondary | Participant Height | height in feet and inches will be recorded at each of the in person meetings | Posted | Mean | Standard Deviation | inches | Timepoint 0 (Baseline at screening) |
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| Secondary | 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". | Number analyzed in the number that completed the group prenatal care acceptability form. This form was added 10/16/2019, after data collection had started. | Posted | Count of Participants | Participants | T1=31 gestational weeks |
|
|
|
| Secondary | 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. | Participants who completed Timepoint 3 after June, 2021, when form was added. 1 participant in the control arm did not complete the question ranking prenatal care delivery. | Posted | Count of Participants | Participants | Timepoint 3, approximately 6 months postpartum |
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| Secondary | 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. | Intervention participants who completed COPE-P acceptability at Timepoint 2 | Posted | Mean | Standard Deviation | score on a scale | Timepoint 2 (6 to 8 weeks postpartum) |
|
|
|
| Secondary | 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. | Participants who completed Timepoint 3 after June, 2021, when form was added. | Posted | Count of Participants | Participants | Timepoint 3, approximately 6 months postpartum |
|
|
|
| 0 |
| 122 |
| 0 |
| 122 |
| 6 |
| 122 |
| EG001 | 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. 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. | 0 | 177 | 3 | 177 | 6 | 177 |
|
| Fetal Demise | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Death of the fetus prior to delivery and after 20 weeks gestation |
|
|
Not provided
Not provided
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| Timepoint 1 |
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| Timepoint 2 |
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| Timepoint 3 |
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| two-way ANOVA |
| <0.001 |
| Other |
| Null hypothesis: There was no statistically significant interaction between the intervention group and time. | two-way ANOVA | <0.001 | Other |
| Timepoint 1 |
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| Timepoint 2 |
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| Timepoint 3 |
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| <0.001 |
| Other |
| Null Hypothesis: There was no statistically significant interaction between the intervention group and time. | two-way ANOVA | <0.001 | Other |
| Timepoint 1 |
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| Timepoint 2 |
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| Timepoint 3 |
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| two-way ANOVA |
| <0.001 |
| Other |
| Null hypothesis: There was no statistically significant interaction between the intervention group and time. | two-way ANOVA | <0.001 | Other |
| Timepoint 1 |
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| Timepoint 2 |
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| Timepoint 3 |
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| two-way ANOVA |
| <0.001 |
| Other |
| Null hypothesis: There was no statistically significant interaction between the intervention group and time. | two-way ANOVA | <0.001 | Other |
| Cesarean Delivery |
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| Timepoint 1 |
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| Timepoint 2 |
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| Timepoint 3 |
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| Timepoint 1 |
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| Timepoint 2 |
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| Timepoint 3 |
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| Neutral |
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| Agree |
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| Strongly Agree |
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| First choice in small group in person |
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| First choice in small group by telehealth |
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| Missing data |
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