Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women: A-RCT
Phase: NA
Conditions: Emotional Disturbances, Depression, Pregnancy Late, Post-Partum Depression, Anxiety, Nutritional Deficiency
Sponsor: Ohio State University

Official Title: Healthy Lifestyle Intervention for High-Risk 
Minority Pregnant Women: A RCT 
NCT Number: NCT03416010 
Document Name: Research Protocol:  Healthy Lifestyle Prenatal 
Care Study 
Document Date: 09.29.2021 
 

07/30/2021 
 
 
Research Protocol:  Healthy Lifestyle Prenatal Care Study 
 
Aims: 
Specific Aim 1. Use a RCT to evaluate the short- and more long-term efficacy of the COPE-P program to 
improve healthy lifestyle behaviors (nutrition and exercise), psychosocial health, and birth and post-natal 
outcomes in pregnant emotionally distressed minority women as compared to an attention control group. 
Hypotheses 1a (primary outcomes).  Immediately after the COPE-P program, at 4-6 weeks postpartum 
(3 months post intervention), and at 6 months postpartum (8 months post intervention), COPE-P participants 
will report higher healthy lifestyle behaviors, and less anxiety, stress and depressive symptoms than will the 
attention control participants.  
Hypothesis 1b (secondary outcomes).  COPE-P participants will demonstrate more appropriate 
pregnancy weight gain, better birth outcomes (mode of delivery, birth weight, and gestational age), more 
appropriate postpartum weight loss, and better breastfeeding outcomes than attention control participants. 
 
Specific Aim 2. Examine the role of cognitive beliefs and perceived difficulty in leading a healthy lifestyle in 
mediating the effects of the COPE-P program on healthy lifestyle behaviors and psychological symptoms in 
minority pregnant women. 
 Hypothesis 2 (theory building exploratory). The effects of the COPE-P program on participants’ healthy 
lifestyle behaviors and levels of anxiety, stress and depressive symptoms will be mediated by beliefs about 
their ability to make healthy lifestyles choices and their perceived difficulty in leading a healthy lifestyle.  
 
Exploratory Aim. Explore characteristics that may moderate healthy lifestyle behaviors, psychosocial health, 
and birth and post-natal outcomes (e.g., race/ethnicity, income, age, parity, language, level of education, 
marital status).  
 
Research Question: What is the short and long-term effect of the COPE-P program in high-risk pregnant 
minority women receiving prenatal care on healthy lifestyle behaviors (nutrition and exercise), 
psychosocial health (healthy lifestyle beliefs, healthy lifestyle behaviors, anxiety, stress and depression), 
and birth and post-natal outcomes (gestational age at birth, gender, birth weight, birth length, overall 
health, mode of delivery, breastfeeding (initiation and duration) versus an attention control group 
(PregnancyPlus group). 
 
Overview of the design.  The study conducted will be a longitudinal randomized block RCT with 
repeated measures (beginning with screening prior to 19 weeks, group prenatal care in both groups 
(COPE-P intervention group and PregnancyPlus attention control group) from 16 + 2 to 31 + 2 weeks and 
ending at 6 months postpartum). We will block on race/ethnicity to ensure equal numbers of Hispanic and 
Black women in the COPE-P and PregnancyPlus groups. There will be a total of 30 groups over the 
course of the study. There will be 22 English speaking groups and 8 Spanish-speaking groups. We will 
consent and screen up to 700 women, knowing that approximately half will screen out. In order to achieve our 
target of 182 Black or Hispanic women who complete the study, and accounting for a 30% attrition rate, we will 
enroll up to 236 women who screen in at Jacobi Medical Center. Four groups (of at least six women per 
group) will run in each 18-week time segment (COPE-P intervention is six sessions each three weeks 
apart). The PregnancyPlus group also will have six group prenatal care sessions each three weeks apart. 
Each session is 1 hour and 30 minutes to 1 hour and 45 minutes in length. Each group within the 18-week 
time segment will be randomly assigned (using a sealed envelope technique) as either a COPE-P or 
PregnancyPlus group. At Jacobi Medical Center in Bronx, NY, for each 18-week time segment, there will 
be two control groups and two intervention groups. The intervention and attention control groups 
programming will be delivered in Group Prenatal Care methodology which begins in the second trimester 
consisting of at least 6 women per group. Participants (18 – 40 years) will be screened prior to their 19th 
week of pregnancy and recruited into the study from the antepartum clinic. 
  
If a participant does not screen into the study, she will be thanked for her time and interest and paid 
$10.00 for her participation in the screening process.  

07/30/2021 
 
 
If a woman does screen into the study, she will provide further baseline data at this point. In addition to the 
screening tools, baseline data will include: demographic and personal information, weight from clinic scale, 
a 24 hour diet recall, the Healthy Lifestyle Beliefs Scale and the Healthy Lifestyle Behaviors Scale. A 
participant will then be assigned to the next available group based on fetal gestational age (groups having 
been scheduled and previously randomized as intervention or control as described above). In the event 
that group prenatal care is not feasible, the group sessions can be conducted as virtual visits (Zoom or 
Facetime etc.) or content can be provided in a 1:1 patient to provider setting.  Participants will then be given 
an appointment for their first group prenatal care session and a Fitbit Flex 2, instructions on how to 
immediately begin using the Fitbit (to provide baseline data that will be uploaded at the first group session) 
and a Fitbit number (for confidentiality) so that they can compare with other pregnant women. All 
participants will receive $30.00 for at the baseline visit (T0). 
 
All women in this study will receive 6 sessions of group prenatal care beginning at 16 weeks gestation (+ 2 
week) and ending at 31 weeks (+ 2 week). At 16 weeks gestation, women receive care every three weeks.  
The timing of our group prenatal care is designed around prenatal testing to decrease participant burden. 
We will begin at 16 weeks when all women in care have alpha-fetal protein screening drawn. The second 
session is at 19 + 2 week, when women are normally receiving an anatomy sonogram. The third session is 
22 + 2 weeks, which is not associated with any specific prenatal care milestones. The fourth session is 25 
+ 2 week is associated with third trimester labs and the glucose tolerance test. The fifth session at 28 
weeks + 2 week and the sixth session at 31 weeks + 2 week are not associated with specific prenatal care 
milestones. Therefore, 3 of the 6 sessions have standard prenatal testing associated with them 
(encouraging attendance). 
 
COPE-P intervention group: The COPE-P intervention group will receive the COPE-P Intervention over 
the 6 sessions of group prenatal care. Each session lasting for 1 and a half hours. 
 
 Session 1 of COPE-P focuses on the thinking, feeling and behaving triangle, and the ABCs 
(A=Antecedent or Activator event, B=Belief that follows the event, C=Consequence: how you feel and how 
you behave). The thinking, feeling and behaving triangle and the ABCs are reinforced throughout the 
program and examples for use are based on peer input.  
 
Session 2 of COPE-P focuses on 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. Signs of poor and 
healthy self-esteem are discussed. Discussion of healthy eating and active living is integrated throughout 
Session 2. Nutrition content includes information on reading labels. Skills building activities for Session 2 
include changing an unhealthy habit into a positive one.  
 
Session 3 of COPE-P focuses on stress and coping during pregnancy. Physical and emotional responses 
to stress are discussed along with healthy snacking. Examples of healthy ways to cope with typical 
stresses are solicited. Signs of depression and anxiety are elicited and the group problem solves positive 
strategies to deal with depression, anxiety, and stress. This skills building session focuses on recognizing 
unhealthy ways of coping and examples of how to unhealthy coping into healthy coping strategies.  
 
Session 4 of COPE-P focuses on planning, goal setting and the 4-step problem solving process, including 
overcoming barriers related to eating. The skills building activity for Session 4 focuses on developing 
strategies for overcoming barriers and problem solving a current challenge. 
 
 
Session 5 of COPE-P focuses on dealing with emotions in healthy ways through positive thinking and 
effective communication. Women practice regulating their emotions along with mental and guided imagery. 
Positive self-control strategies for emotions and unhealthy eating are explored. The skills building activities 
in this session focus on practicing mental imagery and monitoring for emotional triggers with a response 
plan. 
 

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Session 6 of COPE-P focuses on coping with stressful situations commonly encountered during pregnancy 
while continuing to reinforce the thinking, feeling, and behaving triangle. Influences on healthy eating are 
explored. In skills building activities, women practice positively dealing with challenging situations 
PregnancyPlus Attention Control Group: At each group session, the PregnancyPlus attention control 
group will receive the prenatal care described under standard care performed by certified nurse midwives. 
Additionally, each week for six weeks, they will discuss a pamphlet designed for patient education by 
ACOG. These six pamphlets are:  1) Nutrition during pregnancy 2) Exercise during pregnancy 3) Obesity 
and pregnancy 4) Exercise after pregnancy 5) Breastfeeding your baby 6) Routine Tests during 
Pregnancy. At each group prenatal care session, routine obstetric assessment (blood pressure, pulse, 
weight, BMI, urinalysis for glucose and protein, auscultating fetal heart tones, and uterine size 
assessment) will be performed. Routine discomforts of pregnancy, smoking cessation, and danger signs of 
pregnancy will be discussed. Women will return to receiving individualized standard prenatal care at the 
end of the 6 sessions. Dr. Gennaro will conduct the training of the attention control group midwives and 
Dr. Melnyk will conduct the training of the intervention group midwives. The same protocol for assessing 
fidelity will be used for COPE-P and PregnancyPlus.  
 
Different care providers will run the COPE-P and PregnancyPlus groups, assuring that there is no 
carryover effect of the intervention into the control group.  
 
In addition to baseline assessments, at the end of the 18-week timeframe and at their last group prenatal care 
session, all women will complete the GAD-7, PSS, EPDS, a 24 hour diet recall, the Healthy Lifestyle 
Behaviors Scale and the Healthy Lifestyle Beliefs Scale. Fitbit data and weight also will be obtained. In the 
intervention group, participants also will complete the COPE-P evaluation. This data will be T1, and will be 
collected at approximately 31 weeks gestational age. For women who miss this visit, data will be collected at 
the next scheduled prenatal visit. Participants will be compensated $30 for their study participation. 
 
Three months after the intervention (approximately 4-6 weeks postpartum - T2), all women will be contacted 
and will once again complete all measures, as well as an infant data form, at the routine postpartum visit. 
Participants will receive $40.00 for their participation.  
 
At eight months post intervention (T3 - six months postpartum at the six-month well baby visit), all women will 
once again be contacted and complete all measures (including weights taken on available pediatric clinic 
adult scales –same model as prenatal scales). Participants will receive $50.00 for their participation.  
Outcome data from charts will be collected by team members blind to group assignment. 
 
If study visits cannot be conducted face-to-face, data will be collected through telehealth methods such as via 
phone or video call (Zoom or Facetime etc.).  
 
Sampling.  Women will be recruited from the antenatal clinic if they are: between 18 and 40 years old, in their 
first trimester with an uncomplicated singleton pregnancy of less than 19 weeks, and self-identify as either 
Black or Hispanic and can read and speak English or Spanish. A completed sample size of 182 Black and 
Hispanic women from JMC in the Bronx and 182 Black and Hispanic women from OSU Total Health and 
Wellness clinics will be required to meet the determined sample size of 364 total (at 4 data collection points 
for each, resulting in ~1,450 observations). This will have greater than 80% power to detect small to moderate 
effects (i.e. 25 or greater) between group differences in healthy lifestyle behaviors, psychosocial health, and 
outcomes testing at alpha = .05 for all proposed models. The sample of 364 will have > .80 to detect a small 
to medium mediated effect. The sample of 364 will have > .80 to detect a small to medium mediated effect. 
 
Setting.  Jacobi Medical Center is part of New York City Health + Hospitals (NYC H + H), the largest municipal 
hospital system in the United States.  New York City Health + Hospitals oversees the public health care system 
in all the five boroughs that comprise New York City. It provides one-fifth of the total number of discharges and 
more than one-third of the emergency services and hospital-based clinic visits in all of New York City. Jacobi 
Medical Center is an academic affiliate of the Albert Einstein College of Medicine. Jacobi Medical Center is 
located in the Bronx.  As one of the largest health care delivery facilities in the Bronx and in New York City, 
Jacobi Medical Center has developed a world- wide reputation of distinction. It is renowned for its primacy in 

07/30/2021 
 
the delivery of emergency and trauma services, has developed an image of excellence as a provider of choice 
subspecialty care, and is widely recognized for its devotion to the health care needs of the large and diverse 
community it serves. The Bronx population represents a wide range of racial and ethnic diversity with 43.4% of 
the population being African-American and 55% of the population being Hispanic, adding up to more than 
100% as Hispanics may be of any race and are also included in the applicable race category by the U.S. 
Census Bureau (2015). Jacobi Medical Center is an urban medical center, which serves a population of 1.3 
million. The Obstetrics Division serves the region as demonstrated by over 12,000 clinic visits as well as 
approximately 2,000-plus hospital discharges per year. There were 1960 live births at Jacobi Medical Center 
during 2015 with 1373 of these births to Black and Hispanic women. 
 
Obstetrical care is provided by 22 licensed midwives at Jacobi Medical Center as well as by over 40 
obstetricians. There are adequate numbers of bilingual licensed midwives to work with Co-Investigator Anne 
Gibeau, PhD, CNM, RN to provide group prenatal care. There is an excellent working relationship between 
obstetrical and pediatric care providers and both obstetrical and pediatric care providers are interested and 
supportive of this study. 
 
Jacobi Medical Center offers a number of other resources to its obstetrical patients receiving care in the 
Women’s Health Practice.  There are two Women’s Health Patient Educators, who provide a weekly class series, 
with a new curriculum each month covering topics like childbirth education, infant safety and postpartum care. 
Women are encouraged to attend all of them starting in the 7th month of pregnancy.  The Midwifery staff offer 
monthly Childbirth Education classes.  There are two full-time IBCLC-certified Lactation Consultants available to 
patients in both the group and individual setting to assist with the initiation and continuation of breastfeeding. Jacobi 
has a specialized Adolescent Obstetric Practice to meet the needs of young mothers-to-be and Family Planning 
Services.  Pregnant women and new mothers, who meet income eligibility criteria, are assessed by a healthcare 
professional for WIC eligibility which would provide them access to nutrition advice, breastfeeding support, 
nutritious food, and other services.  
 
The Research Center of the NBHN is located at Jacobi Medical Center and has demonstrated its 
proficiency in sound, meticulous, efficient and ethical clinical investigation. Presently running more than 40 
protocols funded by the National Institutes of Health, numerous private foundations, and many industry and 
trade organizations, including the largest Pediatric HIV clinical trial group in the country, the Center meets its 
mission of finding new and better ways to help patients through world-class clinical research and will provide 
support for this current application. The Center is presently conducting investigations by more than 30 
researchers representing every clinical specialty area offered by the NBHN Network. It employs two full time 
regulatory affairs managers who maintain strict adherence to the most stringent submission requirements 
and deadlines, and twelve full-time Research Coordinators. A unique arrangement with two approved 
Investigational Review Boards facilitates the review and approval process. A research coordinator with 
experience in obstetrical research and the ability to speak Spanish will be hired to participate in data 
collection. 
 
     Inclusion and Exclusion Criteria: 
Women will be recruited from the antenatal clinic if they are: 
 
Inclusion criteria. 
• 
Between 18 and 40 years old  
• 
In their first trimester with an uncomplicated singleton pregnancy of less than 19 weeks 
• 
Self-identify as either Black or Hispanic 
• 
Speak and read English or Spanish  
 
Exclusion criteria 
Women will be excluded if they have: 
• 
Chronic medical conditions (e.g., hypertension, or diabetes) 
• 
Currently receiving treatment or therapy for a psychiatric diagnosis 

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• 
Have participated in this study with a prior pregnancy 
• 
Obstetrical complications, such as preeclampsia, gestational diabetes, or fetal abnormalities  
• 
Do not speak and read English or Spanish 
                                                                                             
Recruitment.  Research team members will approach women in the antenatal clinic who may be eligible 
for the study based on their chronological age and fetal gestational age and verbally explain the study. 
Gestational age is based on the ultrasound dating or last menstrual period when ultrasound is not 
available. If a woman self identifies as Black or Hispanic, a participant informed consent form will be 
provided and consent obtained. A copy of the participant informed consent form will be given to the 
participant. She will then be screened for study eligibility.  
 
Measures 
General Anxiety Scale (GAD-7): is a 7-item, 4-point Likert-type scale ranging from (0) Not at all to (3) 
Everyday, that assesses the participants’ level of anxiety over the last 2 weeks.  Scores range from 0 to 21, 
with higher scores indicating greater functional impairment related to the patient’s experience of anxiety. The 
scale’s reliability and validity have been tested across clinical care settings. It has been found useful in 
monitoring symptom severity and changes across time. Brevity of the GAD-7, (it can be completed in 5 minutes 
or less) helps to minimize patient burden. In our COPE-P pilot work, the Cronbach’s alpha was .89. 
Perceived Stress Scale (PSS): is a widely used, 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). Concurrent and predictive validity were supported by comparing the PSS with 
depression scores and life-event scales in college samples. The PSS has demonstrated internal consistency 
reliability of .84 to .86 with young adult populations and .80 with pregnant minority women and takes about 5 
minutes to complete. Cronbach’s alpha in the COPE-P pilot was .80.  
The Edinburgh Postnatal Depression Scale (EPDS): 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. ACOG supports the EPDS as a 
depression screening tool in pregnant women because of its brevity, readability and scoring ease. As will be 
indicated in participant informed consent forms, if a woman answers item 10 (self-harm) with a 1,2, or 3 she will 
be accompanied to a mental health provider for immediate care. Women with high scores will be referred to their 
primary care provider and we will monitor to assure follow up. The EPDS takes 5 minutes to complete.  
24 Hour Adult Nutrition Log: Nutrition will be examined by conducting a 24 hour diet recall for each 
participant at each data point. Food models and pictures will be used to accurately identify portion sizes and 
participants will be asked brand names of food. The target day for the diet recall will be 24 hours in advance of 
the data visit. Information from the diet histories will be analyzed using the Food Processor database that 
contains over 2400 foods. Nutrient values are in accord with information provided by the United States 
Department of Agriculture and over 550 other research sources. Fast foods are included as are over 1182 
convenience food items. he database is updated annually. 
Healthy Lifestyle Beliefs Scale: The HLBS is a 16-item scale adapted from other belief scales used by Co-PI 
Melnyk in prior studies and takes 5 minutes to complete. This scale taps beliefs about various facets of 
maintaining a healthy lifestyle (e.g., “I believe that I can be more active” and “I am sure that I will do what is 
best to lead a healthy life”). Subjects respond to each item on a five point Likert-type scale that ranging from 1 
strongly disagree to 5 strongly agree. Construct validity of the scale has been supported through factor 
analysis with over 1000 young adults. Cronbach’s alpha from the COPE-P pilot was .91. 
Healthy Lifestyle Behaviors Scale: Healthy lifestyle behaviors will be measured with the Healthy Lifestyle 
Behaviors Scale developed for use in multiple prior studies. Subjects 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. Construct validity has been supported through factor analysis from data obtained 
in our prior work. Cronbach’s alpha in the COPE-P pilot was .86 and took 5 minutes to complete. 
Exercise: During pregnancy, spring loaded pedometers have been found to be inaccurate due, to the 
pedometer being tilted away from the vertical plane such that the spring suspended lever arm does not register 

07/30/2021 
 
all steps. This is particularly true for overweight or obese pregnant women so an accelerometer measure of 
step counts is much more accurate. However, accelerometer type measures of physical activity may over 
count steps especially when participants are involved in motor vehicle traffic and most especially on bumpy 
roads. Devices, such as the Fitbit Flex 2, combine accelerometer and pedometer features to improve accuracy 
and have the advantage of being worn on the wrist like a bracelet so women are less likely to forget to use it, a 
common problem with devices that necessitate being affixed to clothing. 
Birth and Post-Natal Outcome Data: will be abstracted from clinic charts by team members blinded to 
treatment group and from the Demographic and Personal Information Form (DPI) completed at T0-T3.  
COPE-P Acceptability: Measures acceptability in 5 minutes at a 6th-grade reading level.  
Group Prenatal Care Acceptability: The Group Prenatal Care Acceptability asks participants to describe 
aspects of their Group Prenatal Care experience on a scale of 1-5 and if they found it helpful. It takes 3-5 
minutes to complete. 
COPE-P/PregnancyPlus Program Evaluation: The Program Evaluation will collect open-ended responses 
from participants evaluating their experience with the COPE-P and the PregnancyPlus program.  The survey 
will take approximately 5-7 minutes to complete.  
 
Table 1. Study Variables, Measures and Timing 
Variables 
Measures 
Timing 
Demographic Characteristics 
Age, Height Education Level, Relationship Status,  
Race/Ethnicity, Language Spoken, Income, Parity, 
Medications, Mental Health Referral/Rx post screening 
Demographic and Personal Information 
(DPI) Form 
T0 =Baseline (screening visit) 
T1 = 31 weeks 
T2= 6-8 weeks postpartum visit 
T3=6 months well baby visit 
Healthy Lifestyle Behaviors 
Healthy Lifestyle Behaviors Scale132 
T0, T1, T2, T3 
 Healthy Lifestyle Beliefs 
Healthy Lifestyle Beliefs Scale141 
T0, T1, T2, T3 
 Nutrition 
24 Hour Nutrition Log/Food Processor 
T0, T1, T2, T3 
 Weight Gain/Loss, BMI 
Scale 
T0, T1, T2, T3 
 Exercise 
Steps Fitbit Flex 2 Accelerometer 
T0 (given at screening 
T1, T2, T3) 
Psychosocial Health 
 
 Anxiety 
GAD7  
T0, T1, T2, T3 
 Depressive Symptoms 
EPDS 
T0, T1, T2, T3 
 Perceived Stress 
PSS 
T0, T1, T2, T3 
Birth and Post-Natal Outcomes 
Infant Data Form 
 
 Gestational Age at birth, Gender 
Chart review 
Post delivery 
 Birth Weight, Birth Length, Overall Health 
Chart review 
Post delivery 
 Mode of Delivery (C/S, Vaginal, Forceps/Vacuum) 
Chart review 
Post delivery 
Breastfeeding (initiation and duration) 
DPI Form 
T2, T3 
COPE-P Acceptability 
Index (COPE-P group) 
T1 and T2 
Group Prenatal Care Acceptability 
Group Prenatal Care Acceptability  
T1 
Program Experience 
COPE-P/PregnancyPlus Program 
Evaluation 
T1 and T3 
 
Procedure.  
After meeting inclusion criteria for the study, she will be given screening tools (General Anxiety Scale – GAD-7, 
Perceived Stress Scale – PSS, and the Edinburgh Postnatal Depression Scale – EPDS) to determine study 
participation. 
If a potential participant scores:  
• 
Greater than or equal to 10 on the General Anxiety Disorder 7-item scale (GAD-7)  
• 
Or greater than or equal to 20 on the Perceived Stress Scale (PSS) 
• 
Or a cut-off score of 10 on the Edinburgh Postnatal Depression Scale (EPDS)  
They will be eligible to participate in the study. For the GAD-7 a score of > to 10 indicates moderate anxiety 
and maximizes sensitivity and specificity, for the PSS, a score of 20 or greater is the high-stress cut-off and a 
cut-off score of 10 on the EPDS is suggested to indicate moderate depressive symptoms in pregnant women. 
  
If a participant does not screen into the study, she will be thanked for her time and interest and paid $10.00 
for her participation in the screening process.  
 

07/30/2021 
 
If a participant does screen into the study, she will provide further baseline data at this point which includes:  
demographic and personal information, weight from clinic scale, a 24 hour diet recall, the Healthy Lifestyle 
Beliefs Scale and the Healthy Lifestyle Behaviors Scale. 
 
A participant will then be assigned to the next available group based on fetal gestational age (groups having 
been scheduled and previously randomized as intervention or control as described above). Participants will 
then be given an appointment for their first group prenatal care session and a Fitbit Flex 2, with instructions on 
how to immediately begin using the Fitbit (to provide baseline data that will be uploaded at the first group 
session) and a Fitbit number (for confidentiality) so that they can compare with other pregnant women. All 
participants will receive $30.00 for at the baseline visit, T0. 
 
All women in this study will receive 6 sessions of group prenatal care beginning at 16 weeks gestation (+ 2 
week) and ending at 31 weeks (+ 2 week) according to previously described randomization into COPE-P 
intervention group or PregnancyPlus attention control group. In the event that group prenatal care is not 
feasible, the group sessions can be conducted as virtual visits (using programs such as Zoom, WebEx, 
Facetime etc.) or content can be provided in a 1:1 patient to provider setting.  Different care providers will 
deliver the COPE-P and PregnancyPlus content, assuring that there is no carryover effect of the intervention 
into the control group. Dr. Gennaro will conduct the training of the attention control group midwives and Dr. 
Melnyk will conduct the training of the intervention group midwives. The same protocol for assessing fidelity will 
be used for COPE-P and PregnancyPlus. Dr. Melnyk will train the research team to assess fidelity of the 
intervention with the intervention fidelity checklist. Fidelity will be assessed by having research team members 
observe 2 of the 6 sessions for each intervention group. Inter-rater reliability of 90% will be established and 
observer drift monitored and corrected throughout the trial. Feedback will be provided immediately after the 
session to interventionists if they are not adhering to the intervention as intended to be delivered. 
 
At the end of the 18-week timeframe and at their last group prenatal care session, all women will complete the 
GAD-7, PSS, EPDS, a 24 hour diet recall, the Healthy Lifestyle Behaviors Scale and the Healthy Lifestyle 
Beliefs Scale. Fitbit data and weight also will be obtained. In the intervention group, participants also will 
complete the COPE-P evaluation. This data will be T1, and will be collected at approximately 31 weeks 
gestational age. For women who miss this visit, data will be collected at the next scheduled prenatal visit. 
Participants will be compensated $30 for their study participation. 
 
Data collection at the 3 month post intervention follow up visit, T2, will occur at the normally scheduled 4-6 
weeks regular postpartum visit. Participants will be compensated $40 for their study participation at this visit. 
All measures will be collected. 
 
The 8 month post-intervention visit, T3, will be the final data collection point and will occur at a routinely 
scheduled 6 month well baby visit. Participants will receive $50 for their participation. All measures will be 
collected. 
 
A research team member will administer the post-intervention follow-up study questionnaires for each data 
collection point (T0 – T3).  It will be noted how many sessions were completed by the participant. Outcome 
data from charts will be collected by team members blind to group assignment.                                              
 
Analysis plan.  
Data management: Survey data will be obtained using paper and pencil surveys and at each site all surveys 
will be scanned using Remark software to ensure accuracy and avoid the necessity of double data entry. Fitbit 
data will be uploaded using Bluetooth technology at each data point (with T0 baseline data being collected 
between screening and the first group prenatal care session) and entered into an Excel database. Data from 
the 24 hour diet recalls will be manually entered at each site into Food Processor and then exported into an 
Excel file for data analyses. At each visit, weights will be recorded. Obstetrical chart data will be extracted at 
each site. Dr. Szalacha will merge the Ohio and New York data files, perform data cleaning, construct analytic 
variables, assess psychometrics and conduct both interim and final analyses. 
 
Data Analysis: Preliminary analyses: Statistical analyses of these data must not only demonstrate the efficacy 

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of the COPE-P intervention, but also map the trajectories of group differences over time, and identify subgroup 
differences. Analysis will begin with characterization of the sample with descriptive statistics that identify 
differences between the COPE-P and PregnancyPlus groups 1) evident at baseline, despite randomization and 
2) between groups due to differential attrition. Data will be screened for normality, outliers, and homogeneity. 
Appropriate nonparametric analyses will be considered in situations of irresolvable heterogeneity. We will 
evaluate the psychometric qualities (reliability, convergent and discriminant validity) of the scales, employing 
both exploratory factor analyses and SEM measurement models. Descriptive statistics will be used to 
summarize the sample characteristics and distribution of each variable. Missing Data. All data analyses will be 
completed as intention to treat analyses (i.e., individuals analyzed by group according to original random 
assignment, without regard to adherence to the intervention). Missing data will be imputed, when appropriate, 
using multiple imputation in SAS v9.4 PROC MI. 
 
Hypothesis-driven analyses. Various bivariate tests (e.g., independent and dependent t-tests, correlations, 
ANCOVA and repeated measures analyses of covariance) will be used to evaluate differences and longitudinal 
patterns of change across time and between relevant subgroups (e.g., intervention groups, language groups) 
for each significant outcome in the preliminary bivariate analyses, (primary outcomes are healthy lifestyle 
behaviors, anxiety, stress, and depressive symptoms). For secondary outcomes (appropriate weight gain 
during pregnancy, birth and post-natal outcomes (e.g., mode of delivery, birth weight/length, gestational age, 
postpartum weight loss and breastfeeding practices) we will fit a series of longitudinal multilevel growth models 
to the data. 
 
For all continuous outcomes, such as anxiety, the basic model, to which we can add our controls and 
predictors.  The level 1 submodel estimates how each participant’s anxiety changes over the four data 
collection periods. The level 2 submodel will relate the inter-individual differences to intervention group and 
other time-invariant predictors and controls, such as medication (i.e., antidepressants) and have begun therapy 
(i.e., in usual care for mental health diagnoses), and will estimate a participant’s initial anxiety level  and rate of 
change in anxiety. Anxiety will be modeled in terms of random subject effects (intercept and time trends) to 
account for individual differences in how participants change over time. We will begin with a linear model for 
time but will investigate nonlinear effects as suggested by the data. Subsequent models will contain time-
varying covariates (i.e., dose of intervention, weight, exercise) and thus will focus on within-participants effects, 
that is, whether within-participant differences in the covariates are associated with within-participant differences 
in anxiety. We will examine the potential of cognitive beliefs and perceived difficulty in leading a healthy 
lifestyle in mediating the effects of the COPE-P program on healthy lifestyle behaviors and psychological 
symptoms. Rather than detecting mediated effects with the causal steps approach of Baron and Kenny, we will 
use the Joint Significance Test established by MacKinnon, which assesses the statistical significance of the X 
to M relation, α path, and then the M to Y relation, β path. If both are statistically significant, there is evidence 
of mediation. Models with more than one mediator are simply extensions of the single-mediator case. In our 
multilevel models, we will investigate mediation effects within the different levels of analysis and across levels. 
Finally, we will explore characteristics that may moderate healthy lifestyle behaviors, psychosocial health, and 
birth outcomes (e.g., race/ethnicity, age, parity, language spoken, level of education, income, marital status) in 
the above models. The proposed examination of mediators and moderators should allow for increased 
understanding of mechanisms underlying any intervention effect and different responses among the 
participants. The most appropriate covariance structure for the residuals εij will be determined after data 
collection and the correlation of responses over time is estimated. Several covariance structures will be 
examined and the resulting models compared for fit using the quasi-likelihood independence model information 
criterion (QIC) fit using SAS 9.4 (Proc MIXED). 
 
Should any of the outcomes need to be dichotomized (i.e., present vs. absent), we will fit a multi-level random 
effects logistic regression models with time-varying covariates. The basic model, to which we will add our 
controls and predictors, can be written: where i indexes participants, t indexes time, COPE-P is an indicator of 
the intervention group, COPE-P x Time is the intervention by time interaction, Xk is a set of time-varying 
covariates measured for each participant I at time t and ui is participant-specific error term. The interaction 
term COPE-P x Time is the test of the effectiveness of the COPE-P program. If successful, the regression 
coefficient will be negative, indicating that the modeled probability of psychological symptoms declined more 

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rapidly with time in the COPE-P group than they did in the PregnancyPlus group. We will fit these models using 
SAS 9.4 (Proc NLMIXED).