Anxiety, Depression, Emotional Disturbances, Nutritional Deficiency, Post-Partum Depression, Pregnancy Late
Conditions
Keywords
emotional distress pregnancy disparities minority depression
Brief summary
The overall purpose of this application is to evaluate the efficacy of an intervention designed to decrease health disparities in pregnant, emotionally distressed, minority women. This randomized controlled trial will test a six session (spaced over 18 weeks) cognitive behavioral skills building (CBSB) prenatal care intervention (specifically designed and based on prior research for pregnant minority women experiencing emotional distress) at three sites (Jacobi Medical Center, New York City and The Ohio State University Total Health and Wellness Clinic, and The Ohio State University Wexner Medical Center OB/GYN Columbus, Ohio.
Detailed description
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.
Interventions
BEHAVIORALCOPE-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.
Sponsors
National Institutes of Health (NIH)
New York University
Jacobi Medical Center
Boston College
University of Arizona
Drexel University
National Institute on Minority Health and Health Disparities (NIMHD)
University of South Florida
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
longitudinal, randomized block RCT with repeated measures
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women between the ages of 18-40 years old * Pregnant women experiencing an uncomplicated singleton pregnancy of less than 19 weeks * Self-identified as either Black or Hispanic * Able to read and speak English. * The child participants born to the participants will have their record accessed for data collection.
Exclusion criteria
* Women with chronic medical conditions (e.g., hypertension, or diabetes), are currently receiving treatment or therapy for a psychiatric diagnosis, or have participated in this study with a prior pregnancy. * Women with obstetrical complications, such as preeclampsia, gestational diabetes, or fetal abnormalities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3 | Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit) | Healthy Lifestyle Beliefs Scale survey will be administered at each of the in-person meetings. This scale taps beliefs about various facets of maintaining a healthy lifestyle. This 16-item is scored on a five point Likert-type scale that ranging from 1 strongly disagree to 5 strongly agree. The minimum score is 16 and the maximum score is 80. The higher the score the higher the beliefs of maintaining a healthy lifestyle. |
| Change in Self-reported Anxiety Level From Timepoint 0 to Timepoint 3 | Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit) | The Generalized Anxiety Scale (GAD-7) is a 7-item survey which measures anxiety will be administered at each of the in-person meetings. The GAD-7 is a 7-item, 4-point Likert-type scale ranging from (0) Not at all to (3). Scores range from 0 to 21, with higher scores indicating greater functional impairment related to the patient's experience of anxiety. A score greater than or equal to 10 indicates moderate and higher anxiety and will be used in this study, |
| Change in Self-reported Healthy Lifestyle Behaviors From Timepoint 0 to Timepoint 3 | Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit) | The Healthy Lifestyle Behaviors Scale survey will be administered at each of the in-person meetings. Participants respond to each of the 15 items (e.g., I exercised regularly; I talked about my worries) on a 5-point Likert-type scale that ranges from 1 strongly disagree to 5 strongly agree. The minimum score is 15 and the maximum score is 75. The higher the score the higher the healthy lifestyle behaviors are practiced. |
| Change in Self-reported Depressive Symptoms From Timepoint 0 to Timepoint 3 | Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit) | The Edinburgh Postnatal Depression Scale (EPDS) is a scale measuring depressive symptoms will be administered at each of the in-person meetings. The Edinburgh Postnatal Depression Scale is a 10 item self-report perinatal depression questionnaire. The scale asks participants to describe how they have felt in the previous week. Unlike other depression screening tools, the EPDS excludes questions regarding somatic symptoms of pregnancy and has been found to be equivalent to a structured interview in determining prevalence of depression. Scores range from 0-30 with higher scores signifying higher severity of depressive symptoms. A cut-off score of 10 on the EPDS will be used in this study to indicate moderate depressive symptoms. |
| Change Self-reported Stress at Timepoint 0 to Timepoint 3 | Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit) | The Perceived Stress Scale (PSS) is a scale measuring stress will be administered at each of the in-person meetings. This scale is a standardized measure of global stress designed to elicit the degree to which respondents find their lives unpredictable, uncontrollable, and overloading (three central components of stress). The minimum score is 0 and the maximum score is 40. A higher score is correlated with a higher amount of stress. A score of 20 or greater is the high stress cut-off and will be used in this study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Program Evaluation | Timepoint 3, approximately 6 months postpartum | Separate forms for intervention and attention control that collected data regarding participant experience in study program as well as delivery method, virtually or in-person. Delivery method was ranked by participants 1-4 for preference: 1:1 in person, 1:1 by telehealth, in small group in person, in small group by telehealth. |
| Level of Exercise | T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit | Fitbit Flex 2 Accelerometer report data: data from Fitbit Flex 2 report will be collected at each of the in-person meetings |
| Gestational Age at Birth | T2= 6-8 week postpartum visit | Gestational age at birth will be collected as reported on patient's medical chart |
| Weight | Timepoint 0 (<19 weeks gestation) | weight in pounds |
| Birth Weight | T2= 6-8 week postpartum visit | record of birth weight as recorded in patient's medical file |
| Participant Height | Timepoint 0 (Baseline at screening) | height in feet and inches will be recorded at each of the in person meetings |
| Group Prenatal Care Acceptability | T1=31 gestational weeks | Survey addressing participant responses to prenatal care in a group setting with 12 Likert scale-type responses: strongly disagree, disagree, neutral, agree, and strongly agree. Participants were also provided a free text box. Reported are responses to the question I would recommend group prenatal care to a friend. |
| Program Evaluation: Delivery Method | Timepoint 3, approximately 6 months postpartum | Separate forms for intervention and attention control that collected data regarding participant experience in study program as well as delivery method, virtually or in-person. Delivery method was ranked by participants 1-4 for preference: 1:1 in person, 1:1 by telehealth, in small group in person, in small group by telehealth. |
| COPE-P Acceptability | Timepoint 2 (6 to 8 weeks postpartum) | Survey administered with likert-style scale exploring participant satisfaction with different aspects of COPE-P. Participant score range 1 (Strongly Disagree) - 5 (Strongly Agree). Minimum score of 21, maximum of 105. High scores indicate higher satisfaction with the COPE-P program and its elements. |
| Participant Body Mass Index (BMI) | Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit | derived calculation from weight and height values reported at each of the in person meetings |
| Breastfeeding Initiation | T2= 6-8 week postpartum visit | Initiation of breastfeeding according to self-report at Timepoint 2: Did you ever breastfeed or try to breastfeed your baby?. Responses below indicated number of participants that responded yes to this question. |
| Breastfeeding Duration | T3 = at 6 month well baby visit | Self-reported maintenance of breastfeeding at approximately 6 months postpartum, inclusive of participants that responded both breastfeeding only and combined breast and bottle feeding (formula vs breastmilk not specified in question to participants). |
| Mode of Delivery | T2= 6-8 week postpartum visit | (C/S, Vaginal, Forceps/Vacuum) |
| Nutritional Intake | Timepoint 0 (<19 weeks gestation), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit | Nutrition behaviors as reflected in response to likert scale-type question I eat fresh fruits and vegetable snacks. Reponses included Strongly Disagree (1), Disagree (2), Neither Agree Nor Disagree (3), Agree (4), Strongly Agree (5). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 122 |
| 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. | 177 |
| Total | 299 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Timepoint 0 (<19 Weeks Gestation) | medically excluded or aged out prior to initiating intervention | 11 | 32 |
| Timepoint 1 (31 Gestational Weeks) | Lost to Follow-up | 11 | 12 |
| Timepoint 1 (31 Gestational Weeks) | Withdrawal by Subject | 27 | 38 |
| Timepoint 2 (6 Weeks Postpartum) | Lost to Follow-up | 1 | 3 |
| Timepoint 2 (6 Weeks Postpartum) | Withdrawal by Subject | 1 | 0 |
| Timepoint 3 (6 Months Postpartum) | Lost to Follow-up | 1 | 3 |
| Timepoint 3 (6 Months Postpartum) | Missing Data | 2 | 3 |
Baseline characteristics
| Characteristic | Control | Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 122 Participants | 177 Participants | 299 Participants |
| Age, Continuous | 26.2 years STANDARD_DEVIATION 5.3 | 26.4 years STANDARD_DEVIATION 5.3 | 26.3 years STANDARD_DEVIATION 5.3 |
| Enrolled in School Did not respond | 1 Participants | 2 Participants | 3 Participants |
| Enrolled in School Enrolled | 103 Participants | 35 Participants | 138 Participants |
| Enrolled in School Not Enrolled | 18 Participants | 140 Participants | 158 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 56 Participants | 68 Participants | 124 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 91 Participants | 140 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 17 Participants | 18 Participants | 35 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 76 Participants | 118 Participants | 194 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 40 Participants | 44 Participants | 84 Participants |
| Race (NIH/OMB) White | 6 Participants | 15 Participants | 21 Participants |
| Region of Enrollment United States | 122 participants | 177 participants | 299 participants |
| Sex: Female, Male Female | 122 Participants | 177 Participants | 299 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 122 | 0 / 177 |
| other Total, other adverse events | 6 / 122 | 6 / 177 |
| serious Total, serious adverse events | 0 / 122 | 3 / 177 |
Outcome results
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,
Time frame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
Population: All participants who completed respective timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Self-reported Anxiety Level From Timepoint 0 to Timepoint 3 | Timepoint 0 | 8.647 units on a scale | Standard Error 0.507 |
| Control | Change in Self-reported Anxiety Level From Timepoint 0 to Timepoint 3 | Timepoint 2 | 3.358 units on a scale | Standard Error 0.526 |
| Control | Change in Self-reported Anxiety Level From Timepoint 0 to Timepoint 3 | Timepoint 1 | 5.500 units on a scale | Standard Error 0.507 |
| Control | Change in Self-reported Anxiety Level From Timepoint 0 to Timepoint 3 | Timepoint 3 | 3.853 units on a scale | Standard Error 0.522 |
| Intervention | Change in Self-reported Anxiety Level From Timepoint 0 to Timepoint 3 | Timepoint 1 | 5.447 units on a scale | Standard Error 0.444 |
| Intervention | Change in Self-reported Anxiety Level From Timepoint 0 to Timepoint 3 | Timepoint 0 | 9.018 units on a scale | Standard Error 0.329 |
| Intervention | Change in Self-reported Anxiety Level From Timepoint 0 to Timepoint 3 | Timepoint 3 | 4.398 units on a scale | Standard Error 0.459 |
| Intervention | Change in Self-reported Anxiety Level From Timepoint 0 to Timepoint 3 | Timepoint 2 | 4.114 units on a scale | Standard Error 0.459 |
Comparison: Null hypothesis: there was no significant difference in anxiety across the 4 time points.p-value: <0.001two-way ANOVA
Comparison: Null hypothesis: There was no significant difference between the two groups in anxiety at T0 baseline, as well as at timepoint 1(immediately following the intervention), timepoint 2 (6 weeks after the infants' birth), and timepoint 3 (6 months after the infants' birth).p-value: <0.001two-way ANOVA
Comparison: Null hypothesis: There was no statistically significant interaction between the intervention group and time.p-value: <0.001two-way ANOVA
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.
Time frame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
Population: All participants completing data collection at respective timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Self-reported Depressive Symptoms From Timepoint 0 to Timepoint 3 | Timepoint 0 | 13.042 units on a scale | Standard Error 0.435 |
| Control | Change in Self-reported Depressive Symptoms From Timepoint 0 to Timepoint 3 | Timepoint 1 | 7.000 units on a scale | Standard Error 0.56 |
| Control | Change in Self-reported Depressive Symptoms From Timepoint 0 to Timepoint 3 | Timepoint 2 | 6.119 units on a scale | Standard Error 0.58 |
| Control | Change in Self-reported Depressive Symptoms From Timepoint 0 to Timepoint 3 | Timepoint 3 | 6.662 units on a scale | Standard Error 0.576 |
| Intervention | Change in Self-reported Depressive Symptoms From Timepoint 0 to Timepoint 3 | Timepoint 3 | 6.818 units on a scale | Standard Error 0.506 |
| Intervention | Change in Self-reported Depressive Symptoms From Timepoint 0 to Timepoint 3 | Timepoint 0 | 12.855 units on a scale | Standard Error 0.362 |
| Intervention | Change in Self-reported Depressive Symptoms From Timepoint 0 to Timepoint 3 | Timepoint 2 | 6.545 units on a scale | Standard Error 0.506 |
| Intervention | Change in Self-reported Depressive Symptoms From Timepoint 0 to Timepoint 3 | Timepoint 1 | 7.776 units on a scale | Standard Error 0.49 |
Comparison: Null hypothesis: There was no significant difference in depressive symptoms across those 4 timepoints.p-value: <0.001two-way ANOVA
Comparison: Null hypothesis: There was no significant difference between the two groups in depressive symptoms at T0 baseline, as well as at time points 1, immediately following the intervention, 2, 6 weeks after the infants' birth, and 3, 6 months after the infants' birth.p-value: <0.001two-way ANOVA
Comparison: Null hypothesis: There was no statistically significant interaction between the intervention group and time.p-value: <0.001two-way ANOVA
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.
Time frame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
Population: All participants who completed data collection at respective timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | 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 |
| Control | 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 |
| Control | 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 |
| Control | 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 |
| Intervention | Change in Self-reported Healthy Lifestyle Behaviors From Timepoint 0 to Timepoint 3 | Timepoint 3 | 56.209 units on a scale | Standard Error 0.897 |
| Intervention | Change in Self-reported Healthy Lifestyle Behaviors From Timepoint 0 to Timepoint 3 | Timepoint 0 | 50.669 units on a scale | Standard Error 0.73 |
| Intervention | Change in Self-reported Healthy Lifestyle Behaviors From Timepoint 0 to Timepoint 3 | Timepoint 2 | 57.267 units on a scale | Standard Error 0.897 |
| Intervention | Change in Self-reported Healthy Lifestyle Behaviors From Timepoint 0 to Timepoint 3 | Timepoint 1 | 56.783 units on a scale | Standard Error 0.868 |
Comparison: Null hypothesis: There was no significant difference in health behaviors across those 4 time points.p-value: <0.001two-way ANOVA
p-value: <0.001two-way ANOVA
Comparison: Null Hypothesis: There was no statistically significant interaction between the intervention group and time.p-value: <0.001two-way ANOVA
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.
Time frame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
Population: All participants who completed data collection at respective timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3 | Timepoint 0 | 59.044 units on a scale | Standard Error 0.736 |
| Control | Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3 | Timepoint 1 | 64.972 units on a scale | Standard Error 0.823 |
| Control | Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3 | Timepoint 2 | 63.683 units on a scale | Standard Error 0.88 |
| Control | Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3 | Timepoint 3 | 63.328 units on a scale | Standard Error 0.853 |
| Intervention | Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3 | Timepoint 3 | 63.852 units on a scale | Standard Error 0.744 |
| Intervention | Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3 | Timepoint 0 | 59.349 units on a scale | Standard Error 0.615 |
| Intervention | Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3 | Timepoint 2 | 64.614 units on a scale | Standard Error 0.744 |
| Intervention | Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3 | Timepoint 1 | 64.234 units on a scale | Standard Error 0.72 |
Comparison: Null Hypothesis: There was no significant difference in Health Beliefs across those 4 time points.p-value: <0.001two-way ANOVA
Comparison: Null hypothesis: There was no significant difference between the full intervention group, COPE-P, and the attention-control group, Preg+, in Health Beliefs, as measured by the Healthy Lifestyle Beliefs measure, at T0 baseline, as well as at time points 1, immediately following the intervention, 2, 6 weeks after the infants' birth, and 3, 6 months after the infants' birthp-value: <0.001two-way ANOVA
Comparison: Null hypothesis: There was no statistically significant interaction between the intervention group and time.p-value: 0.009two-way ANOVA
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.
Time frame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
Population: All participants completing data collection at respective timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change Self-reported Stress at Timepoint 0 to Timepoint 3 | Timepoint 0 | 21.857 units on a scale | Standard Error 0.562 |
| Control | Change Self-reported Stress at Timepoint 0 to Timepoint 3 | Timepoint 1 | 15.278 units on a scale | Standard Error 0.723 |
| Control | Change Self-reported Stress at Timepoint 0 to Timepoint 3 | Timepoint 2 | 12.448 units on a scale | Standard Error 0.75 |
| Control | Change Self-reported Stress at Timepoint 0 to Timepoint 3 | Timepoint 3 | 13.971 units on a scale | Standard Error 0.744 |
| Intervention | Change Self-reported Stress at Timepoint 0 to Timepoint 3 | Timepoint 3 | 14.193 units on a scale | Standard Error 0.654 |
| Intervention | Change Self-reported Stress at Timepoint 0 to Timepoint 3 | Timepoint 0 | 21.971 units on a scale | Standard Error 0.468 |
| Intervention | Change Self-reported Stress at Timepoint 0 to Timepoint 3 | Timepoint 2 | 13.420 units on a scale | Standard Error 0.654 |
| Intervention | Change Self-reported Stress at Timepoint 0 to Timepoint 3 | Timepoint 1 | 15.596 units on a scale | Standard Error 0.633 |
Comparison: Null hypothesis: There was no significant difference in stress across those 4 time points.p-value: <0.001two-way ANOVA
Comparison: Null hypothesis: There was no significant difference between the two groups in stress, as measured by the GAD-7, at T0 baseline, as well as at timepoint 1 (immediately following the intervention), timepoint 2 (6 weeks after the infants' birth) and timepoint 3 (6 months after the infants' birth).p-value: <0.001two-way ANOVA
Comparison: Null hypothesis: There was no statistically significant interaction between the intervention group and time.p-value: <0.001two-way ANOVA
Secondary
Birth Weight
record of birth weight as recorded in patient's medical file
Time frame: T2= 6-8 week postpartum visit
Population: Infant weight was not available for all participants who completed timepoint (i.e. delivered at outside institution)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Birth Weight | 3139.9 grams | Standard Deviation 740.3 |
| Intervention | Birth Weight | 3310.1 grams | Standard Deviation 732.6 |
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).
Time frame: T3 = at 6 month well baby visit
Population: Number of participants who completed Timepoint 3
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Breastfeeding Duration | 18 Participants |
| Intervention | Breastfeeding Duration | 34 Participants |
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.
Time frame: T2= 6-8 week postpartum visit
Population: Number of participants that completed Timepoint 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Breastfeeding Initiation | 64 Participants |
| Intervention | Breastfeeding Initiation | 83 Participants |
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.
Time frame: Timepoint 2 (6 to 8 weeks postpartum)
Population: Intervention participants who completed COPE-P acceptability at Timepoint 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | COPE-P Acceptability | 94.05 score on a scale | Standard Deviation 9.06 |
Secondary
Gestational Age at Birth
Gestational age at birth will be collected as reported on patient's medical chart
Time frame: T2= 6-8 week postpartum visit
Population: Gestational age was not available for all participants who completed timepoint (i.e. delivered at outside institution)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Gestational Age at Birth | 39.0 weeks | Standard Deviation 1.9 |
| Intervention | Gestational Age at Birth | 38.8 weeks | Standard Deviation 1.8 |
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.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Group Prenatal Care Acceptability | Disagree | 0 Participants |
| Control | Group Prenatal Care Acceptability | Agree | 15 Participants |
| Control | Group Prenatal Care Acceptability | Neutral | 1 Participants |
| Control | Group Prenatal Care Acceptability | Strongly Agree | 42 Participants |
| Control | Group Prenatal Care Acceptability | Strongly Disagree | 0 Participants |
| Intervention | Group Prenatal Care Acceptability | Strongly Agree | 40 Participants |
| Intervention | Group Prenatal Care Acceptability | Strongly Disagree | 0 Participants |
| Intervention | Group Prenatal Care Acceptability | Disagree | 0 Participants |
| Intervention | Group Prenatal Care Acceptability | Neutral | 0 Participants |
| Intervention | Group Prenatal Care Acceptability | Agree | 16 Participants |
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
Time frame: 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.
Secondary
Mode of Delivery
(C/S, Vaginal, Forceps/Vacuum)
Time frame: T2= 6-8 week postpartum visit
Population: Delivery mode not available for all participants who completed timepoint (i.e. delivered at outside institution)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Mode of Delivery | Vaginal Delivery | 52 Participants |
| Control | Mode of Delivery | Assisted Vaginal Delivery (forceps, vacuum) | 0 Participants |
| Control | Mode of Delivery | Cesarean Delivery | 17 Participants |
| Intervention | Mode of Delivery | Vaginal Delivery | 52 Participants |
| Intervention | Mode of Delivery | Assisted Vaginal Delivery (forceps, vacuum) | 4 Participants |
| Intervention | Mode of Delivery | Cesarean Delivery | 29 Participants |
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Nutritional Intake | Timepoint 0 | 3.955 units on a scale | Standard Error 0.088 |
| Control | Nutritional Intake | Timepoint 1 | 4.264 units on a scale | Standard Error 0.098 |
| Control | Nutritional Intake | Timepoint 2 | 4.075 units on a scale | Standard Error 0.101 |
| Control | Nutritional Intake | Timepoint 3 | 4.169 units on a scale | Standard Error 0.103 |
| Intervention | Nutritional Intake | Timepoint 3 | 4.173 units on a scale | Standard Error 0.092 |
| Intervention | Nutritional Intake | Timepoint 0 | 4.070 units on a scale | Standard Error 0.073 |
| Intervention | Nutritional Intake | Timepoint 2 | 4.200 units on a scale | Standard Error 0.09 |
| Intervention | Nutritional Intake | Timepoint 1 | 4.298 units on a scale | Standard Error 0.085 |
Secondary
Participant Body Mass Index (BMI)
derived calculation from weight and height values reported at each of the in person meetings
Time frame: Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Participant Body Mass Index (BMI) | Timepoint 0 | 29.4 kg/m^2 | Standard Deviation 7.6 |
| Control | Participant Body Mass Index (BMI) | Timepoint 1 | 33.1 kg/m^2 | Standard Deviation 7.8 |
| Control | Participant Body Mass Index (BMI) | Timepoint 2 | 31.2 kg/m^2 | Standard Deviation 7.3 |
| Control | Participant Body Mass Index (BMI) | Timepoint 3 | 31.0 kg/m^2 | Standard Deviation 8 |
| Intervention | Participant Body Mass Index (BMI) | Timepoint 3 | 30.4 kg/m^2 | Standard Deviation 8 |
| Intervention | Participant Body Mass Index (BMI) | Timepoint 0 | 29.2 kg/m^2 | Standard Deviation 7.5 |
| Intervention | Participant Body Mass Index (BMI) | Timepoint 2 | 29.7 kg/m^2 | Standard Deviation 7.2 |
| Intervention | Participant Body Mass Index (BMI) | Timepoint 1 | 31.8 kg/m^2 | Standard Deviation 7.9 |
Secondary
Participant Height
height in feet and inches will be recorded at each of the in person meetings
Time frame: Timepoint 0 (Baseline at screening)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Participant Height | 63.9 inches | Standard Deviation 3 |
| Intervention | Participant Height | 63.9 inches | Standard Deviation 3 |
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.
Time frame: Timepoint 3, approximately 6 months postpartum
Population: Participants who completed Timepoint 3 after June, 2021, when form was added.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Program Evaluation | Program helpful: yes | 31 Participants |
| Control | Program Evaluation | Program helpful: no | 0 Participants |
| Intervention | Program Evaluation | Program helpful: yes | 30 Participants |
| Intervention | Program Evaluation | Program helpful: no | 1 Participants |
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.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Program Evaluation: Delivery Method | First choice 1:1 by telehealth | 3 Participants |
| Control | Program Evaluation: Delivery Method | First choice in small group by telehealth | 9 Participants |
| Control | Program Evaluation: Delivery Method | First choice in small group in person | 9 Participants |
| Control | Program Evaluation: Delivery Method | Missing data | 1 Participants |
| Control | Program Evaluation: Delivery Method | First choice 1:1 in person | 9 Participants |
| Intervention | Program Evaluation: Delivery Method | Missing data | 0 Participants |
| Intervention | Program Evaluation: Delivery Method | First choice 1:1 in person | 6 Participants |
| Intervention | Program Evaluation: Delivery Method | First choice 1:1 by telehealth | 2 Participants |
| Intervention | Program Evaluation: Delivery Method | First choice in small group in person | 17 Participants |
| Intervention | Program Evaluation: Delivery Method | First choice in small group by telehealth | 6 Participants |
Secondary
Weight
weight in pounds
Time frame: Timepoint 0 (<19 weeks gestation)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Weight | 174.3 pounds | Standard Deviation 47.2 |
| Intervention | Weight | 171.0 pounds | Standard Deviation 46.7 |