Trial Outcomes & Findings for Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women (NCT NCT03416010)

NCT ID: NCT03416010

Last Updated: 2025-03-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 299 participants
• Primary outcome timeframe: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
• Results posted on: 2025-03-18

Participant Flow

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.

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 milestones

Measure	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.	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.
Timepoint 0 (<19 Weeks Gestation) STARTED	122	177
Timepoint 0 (<19 Weeks Gestation) COMPLETED	111	145
Timepoint 0 (<19 Weeks Gestation) NOT COMPLETED	11	32
Timepoint 1 (31 Gestational Weeks) STARTED	111	145
Timepoint 1 (31 Gestational Weeks) COMPLETED	73	95
Timepoint 1 (31 Gestational Weeks) NOT COMPLETED	38	50
Timepoint 2 (6 Weeks Postpartum) STARTED	73	95
Timepoint 2 (6 Weeks Postpartum) COMPLETED	71	92
Timepoint 2 (6 Weeks Postpartum) NOT COMPLETED	2	3
Timepoint 3 (6 Months Postpartum) STARTED	71	92
Timepoint 3 (6 Months Postpartum) COMPLETED	68	86
Timepoint 3 (6 Months Postpartum) NOT COMPLETED	3	6

Reasons for withdrawal

Measure	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.	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.
Timepoint 0 (<19 Weeks Gestation) medically excluded or aged out prior to initiating intervention	11	32
Timepoint 1 (31 Gestational Weeks) Withdrawal by Subject	27	38
Timepoint 1 (31 Gestational Weeks) Lost to Follow-up	11	12
Timepoint 2 (6 Weeks Postpartum) Withdrawal by Subject	1	0
Timepoint 2 (6 Weeks Postpartum) Lost to Follow-up	1	3
Timepoint 3 (6 Months Postpartum) Lost to Follow-up	1	3
Timepoint 3 (6 Months Postpartum) Missing Data	2	3

Baseline Characteristics

Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women

Baseline characteristics by cohort

Measure	Control n=122 Participants 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 n=177 Participants 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.	Total n=299 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	122 Participants n=5 Participants	177 Participants n=7 Participants	299 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	26.2 years STANDARD_DEVIATION 5.3 • n=5 Participants	26.4 years STANDARD_DEVIATION 5.3 • n=7 Participants	26.3 years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex: Female, Male Female	122 Participants n=5 Participants	177 Participants n=7 Participants	299 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	56 Participants n=5 Participants	68 Participants n=7 Participants	124 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=5 Participants	91 Participants n=7 Participants	140 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	76 Participants n=5 Participants	118 Participants n=7 Participants	194 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	15 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	40 Participants n=5 Participants	44 Participants n=7 Participants	84 Participants n=5 Participants
Region of Enrollment United States	122 participants n=5 Participants	177 participants n=7 Participants	299 participants n=5 Participants
Enrolled in School Enrolled	103 Participants n=5 Participants	35 Participants n=7 Participants	138 Participants n=5 Participants
Enrolled in School Not Enrolled	18 Participants n=5 Participants	140 Participants n=7 Participants	158 Participants n=5 Participants
Enrolled in School Did not respond	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)

Population: All participants who completed data collection at respective timepoints.

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.

Outcome measures

Measure	Control n=122 Participants 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 n=177 Participants 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.
Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3 Timepoint 0	59.044 units on a scale Standard Error 0.736	59.349 units on a scale Standard Error 0.615
Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3 Timepoint 1	64.972 units on a scale Standard Error 0.823	64.234 units on a scale Standard Error 0.720
Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3 Timepoint 2	63.683 units on a scale Standard Error 0.880	64.614 units on a scale Standard Error 0.744
Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3 Timepoint 3	63.328 units on a scale Standard Error 0.853	63.852 units on a scale Standard Error 0.744

PRIMARY outcome

Timeframe: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)

Population: All participants who completed respective timepoints.

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,

Outcome measures

Measure	Control n=122 Participants 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 n=177 Participants 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.
Change in Self-reported Anxiety Level From Timepoint 0 to Timepoint 3 Timepoint 0	8.647 units on a scale Standard Error 0.507	9.018 units on a scale Standard Error 0.329
Change in Self-reported Anxiety Level From Timepoint 0 to Timepoint 3 Timepoint 1	5.500 units on a scale Standard Error 0.507	5.447 units on a scale Standard Error 0.444
Change in Self-reported Anxiety Level From Timepoint 0 to Timepoint 3 Timepoint 2	3.358 units on a scale Standard Error 0.526	4.114 units on a scale Standard Error 0.459
Change in Self-reported Anxiety Level From Timepoint 0 to Timepoint 3 Timepoint 3	3.853 units on a scale Standard Error 0.522	4.398 units on a scale Standard Error 0.459

PRIMARY outcome

Timeframe: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)

Population: All participants who completed data collection at respective timepoints.

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.

Outcome measures

Measure	Control n=122 Participants 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 n=177 Participants 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.
Change in Self-reported Healthy Lifestyle Behaviors From Timepoint 0 to Timepoint 3 Timepoint 0	49.506 units on a scale Standard Error 0.903	50.669 units on a scale Standard Error 0.730
Change in Self-reported Healthy Lifestyle Behaviors From Timepoint 0 to Timepoint 3 Timepoint 1	56.194 units on a scale Standard Error 0.981	56.783 units on a scale Standard Error 0.868
Change in Self-reported Healthy Lifestyle Behaviors From Timepoint 0 to Timepoint 3 Timepoint 2	53.677 units on a scale Standard Error 1.032	57.267 units on a scale Standard Error 0.897
Change in Self-reported Healthy Lifestyle Behaviors From Timepoint 0 to Timepoint 3 Timepoint 3	55.692 units on a scale Standard Error 1.032	56.209 units on a scale Standard Error 0.897

PRIMARY outcome

Timeframe: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)

Population: All participants completing data collection at respective timepoints.

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.

Outcome measures

Measure	Control n=122 Participants 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 n=177 Participants 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.
Change in Self-reported Depressive Symptoms From Timepoint 0 to Timepoint 3 Timepoint 0	13.042 units on a scale Standard Error 0.435	12.855 units on a scale Standard Error 0.362
Change in Self-reported Depressive Symptoms From Timepoint 0 to Timepoint 3 Timepoint 1	7.000 units on a scale Standard Error 0.560	7.776 units on a scale Standard Error 0.490
Change in Self-reported Depressive Symptoms From Timepoint 0 to Timepoint 3 Timepoint 2	6.119 units on a scale Standard Error 0.580	6.545 units on a scale Standard Error 0.506
Change in Self-reported Depressive Symptoms From Timepoint 0 to Timepoint 3 Timepoint 3	6.662 units on a scale Standard Error 0.576	6.818 units on a scale Standard Error 0.506

PRIMARY outcome

Timeframe: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)

Population: All participants completing data collection at respective timepoints.

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.

Outcome measures

Measure	Control n=122 Participants 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 n=177 Participants 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.
Change Self-reported Stress at Timepoint 0 to Timepoint 3 Timepoint 0	21.857 units on a scale Standard Error 0.562	21.971 units on a scale Standard Error 0.468
Change Self-reported Stress at Timepoint 0 to Timepoint 3 Timepoint 1	15.278 units on a scale Standard Error 0.723	15.596 units on a scale Standard Error 0.633
Change Self-reported Stress at Timepoint 0 to Timepoint 3 Timepoint 2	12.448 units on a scale Standard Error 0.750	13.420 units on a scale Standard Error 0.654
Change Self-reported Stress at Timepoint 0 to Timepoint 3 Timepoint 3	13.971 units on a scale Standard Error 0.744	14.193 units on a scale Standard Error 0.654

SECONDARY outcome

Timeframe: T2= 6-8 week postpartum visit

Population: Infant weight was not available for all participants who completed timepoint (i.e. delivered at outside institution)

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

Outcome measures

Measure	Control n=68 Participants 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 n=82 Participants 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.
Birth Weight	3139.9 grams Standard Deviation 740.3	3310.1 grams Standard Deviation 732.6

SECONDARY outcome

Timeframe: T2= 6-8 week postpartum visit

Population: Number of participants that completed Timepoint 2

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.

Outcome measures

Measure	Control n=71 Participants 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 n=92 Participants 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.
Breastfeeding Initiation	64 Participants	83 Participants

SECONDARY outcome

Timeframe: T3 = at 6 month well baby visit

Population: Number of participants who completed Timepoint 3

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).

Outcome measures

Measure	Control n=68 Participants 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 n=86 Participants 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.
Breastfeeding Duration	18 Participants	34 Participants

SECONDARY outcome

Timeframe: T2= 6-8 week postpartum visit

Population: Delivery mode not available for all participants who completed timepoint (i.e. delivered at outside institution)

(C/S, Vaginal, Forceps/Vacuum)

Outcome measures

Measure	Control n=69 Participants 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 n=85 Participants 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.
Mode of Delivery Vaginal Delivery	52 Participants	52 Participants
Mode of Delivery Assisted Vaginal Delivery (forceps, vacuum)	0 Participants	4 Participants
Mode of Delivery Cesarean Delivery	17 Participants	29 Participants

SECONDARY outcome

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

Population: Each row represents a study timepoint. Number analyzed in the number of participants who completed the respective timepoint.

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).

Outcome measures

Measure	Control n=122 Participants 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 n=177 Participants 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.
Nutritional Intake Timepoint 0	3.955 units on a scale Standard Error 0.088	4.070 units on a scale Standard Error 0.073
Nutritional Intake Timepoint 1	4.264 units on a scale Standard Error 0.098	4.298 units on a scale Standard Error 0.085
Nutritional Intake Timepoint 2	4.075 units on a scale Standard Error 0.101	4.200 units on a scale Standard Error 0.090
Nutritional Intake Timepoint 3	4.169 units on a scale Standard Error 0.103	4.173 units on a scale Standard Error 0.092

SECONDARY outcome

Timeframe: T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit

Population: 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.

Fitbit Flex 2 Accelerometer report data: data from Fitbit Flex 2 report will be collected at each of the in-person meetings

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: T2= 6-8 week postpartum visit

Population: Gestational age was not available for all participants who completed timepoint (i.e. delivered at outside institution)

Gestational age at birth will be collected as reported on patient's medical chart

Outcome measures

Measure	Control n=68 Participants 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 n=82 Participants 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.
Gestational Age at Birth	39.0 weeks Standard Deviation 1.9	38.8 weeks Standard Deviation 1.8

SECONDARY outcome

Timeframe: Timepoint 0 (<19 weeks gestation)

weight in pounds

Outcome measures

Measure	Control n=122 Participants 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 n=177 Participants 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.
Weight	174.3 pounds Standard Deviation 47.2	171.0 pounds Standard Deviation 46.7

SECONDARY outcome

Timeframe: Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit

Population: 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).

derived calculation from weight and height values reported at each of the in person meetings

Outcome measures

Measure	Control n=122 Participants 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 n=177 Participants 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.
Participant Body Mass Index (BMI) Timepoint 3	31.0 kg/m^2 Standard Deviation 8.0	30.4 kg/m^2 Standard Deviation 8.0
Participant Body Mass Index (BMI) Timepoint 0	29.4 kg/m^2 Standard Deviation 7.6	29.2 kg/m^2 Standard Deviation 7.5
Participant Body Mass Index (BMI) Timepoint 1	33.1 kg/m^2 Standard Deviation 7.8	31.8 kg/m^2 Standard Deviation 7.9
Participant Body Mass Index (BMI) Timepoint 2	31.2 kg/m^2 Standard Deviation 7.3	29.7 kg/m^2 Standard Deviation 7.2

SECONDARY outcome

Timeframe: Timepoint 0 (Baseline at screening)

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

Outcome measures

Measure	Control n=122 Participants 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 n=177 Participants 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.
Participant Height	63.9 inches Standard Deviation 3.0	63.9 inches Standard Deviation 3.0

SECONDARY outcome

Timeframe: T1=31 gestational weeks

Population: 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.

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".

Outcome measures

Measure	Control n=58 Participants 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 n=56 Participants 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.
Group Prenatal Care Acceptability Strongly Disagree	0 Participants	0 Participants
Group Prenatal Care Acceptability Disagree	0 Participants	0 Participants
Group Prenatal Care Acceptability Neutral	1 Participants	0 Participants
Group Prenatal Care Acceptability Agree	15 Participants	16 Participants
Group Prenatal Care Acceptability Strongly Agree	42 Participants	40 Participants

SECONDARY outcome

Timeframe: Timepoint 3, approximately 6 months postpartum

Population: 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.

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.

Outcome measures

Measure	Control n=31 Participants 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 n=31 Participants 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.
Program Evaluation: Delivery Method First choice 1:1 in person	9 Participants	6 Participants
Program Evaluation: Delivery Method First choice 1:1 by telehealth	3 Participants	2 Participants
Program Evaluation: Delivery Method First choice in small group in person	9 Participants	17 Participants
Program Evaluation: Delivery Method First choice in small group by telehealth	9 Participants	6 Participants
Program Evaluation: Delivery Method Missing data	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Timepoint 2 (6 to 8 weeks postpartum)

Population: Intervention participants who completed COPE-P acceptability at Timepoint 2

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.

Outcome measures

Measure	Control n=86 Participants 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 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.
COPE-P Acceptability	94.05 score on a scale Standard Deviation 9.06	—

SECONDARY outcome

Timeframe: Timepoint 3, approximately 6 months postpartum

Population: Participants who completed Timepoint 3 after June, 2021, when form was added.

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.

Outcome measures

Measure	Control n=31 Participants 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 n=31 Participants 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.
Program Evaluation Program helpful: yes	31 Participants	30 Participants
Program Evaluation Program helpful: no	0 Participants	1 Participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Intervention

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control n=122 participants at risk 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 n=177 participants at risk 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.
Psychiatric disorders Suicide Attempt	0.00% 0/122 • From baseline (<19 weeks gestation) to collection of Timepoint 3, approximately 6 months postpartum.	0.56% 1/177 • Number of events 1 • From baseline (<19 weeks gestation) to collection of Timepoint 3, approximately 6 months postpartum.
Pregnancy, puerperium and perinatal conditions Fetal Demise	0.00% 0/122 • From baseline (<19 weeks gestation) to collection of Timepoint 3, approximately 6 months postpartum.	1.1% 2/177 • Number of events 2 • From baseline (<19 weeks gestation) to collection of Timepoint 3, approximately 6 months postpartum.

Other adverse events

Measure	Control n=122 participants at risk 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 n=177 participants at risk 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.
Pregnancy, puerperium and perinatal conditions Preterm Birth	8.5% 6/71 • Number of events 6 • From baseline (<19 weeks gestation) to collection of Timepoint 3, approximately 6 months postpartum.	6.5% 6/92 • Number of events 6 • From baseline (<19 weeks gestation) to collection of Timepoint 3, approximately 6 months postpartum.

Additional Information

Dr. Bernadette Melnyk

The Ohio State University

Phone: 6142924844

Email: melnyk.15@osu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place