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Development of a Nationally Scalable Model of Group Prenatal Care to Improve Birth Outcomes: "Expect With Me"

Primary Purpose

Pregnancy, Premature Birth, Infant, Low Birth Weight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Expect With Me group prenatal care
Standard individual prenatal care
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring prenatal care, group care, Expect With Me, evaluation studies, group prenatal care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • less than 24 weeks pregnant
  • able to attend groups conducted in English or Spanish
  • consent to share their data with the study

Exclusion Criteria:

  • severe medical problem requiring individual care only, as determined by the participating clinical practice

Sites / Locations

  • Wayne State University
  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Expect With Me group prenatal care

Individual Care Only

Arm Description

receiving prenatal care through an Expect With Me group

Standard of Care- individual prenatal care

Outcomes

Primary Outcome Measures

Risk of preterm birth incidence
Incidence risk of delivery before 37 weeks gestation
Risk of low birth weight incidence
Incidence risk of infant weight at birth < 2500 grams
Risk of small for gestational age incidence
Incidence risk of infant weight below the 10th percentile for the gestational age at birth
Risk of neonatal intensive care unit (NICU) admission incidence
Incidence risk of being admitted to the neonatal intensive care unit (NICU) at birth

Secondary Outcome Measures

breastfeeding
initiation and duration of breastfeeding
nutrition
nutritional choices, food security, and use of mindful eating practices
physical activity
level of physical activity in a typical week
readiness for labor and delivery
readiness for labor and delivery
readiness for taking care of baby
readiness for taking care of baby
social support
multidimensional scale of perceived social support subscale
condom use self-efficacy
condom use self efficacy scale
substance use
use of cigarettes, alcohol, and drugs
care satisfaction
satisfaction with Expect With Me group prenatal care and use of program components
adherence to medical recommendations
adherence to medical recommendations (e.g., 6-week postpartum check, pediatric visits, vaccinations, infant feeding)
postpartum body mass index
individual's body weight divided by the square of their height (kg/m2)
maternal weight gain
weight gain as compared to medical recommendations
mode of delivery
mode of delivery (e.g., cesarean, vaginal)
sexual risk: condom use
condom use percent (0-100%)
sexual risk: contraceptive use (LARC)
use of other contraceptives to prevent pregnancy (no/yes)
sexual risk: number of sexual partners
number of partners
sexual risk: sexually transmitted infection
sexually transmitted infection (no/yes, during pregnancy or incident postpartum)

Full Information

First Posted
June 18, 2014
Last Updated
May 27, 2020
Sponsor
Yale University
Collaborators
United Health Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02169024
Brief Title
Development of a Nationally Scalable Model of Group Prenatal Care to Improve Birth Outcomes: "Expect With Me"
Official Title
Development of a Nationally Scalable Model of Group Prenatal Care to Improve Birth Outcomes: "Expect With Me"
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
United Health Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study addresses the intractable challenges of adverse birth outcomes, including preterm delivery and low birthweight, by proposing the development, implementation and evaluation of a model of group prenatal care that could be scaled nationally. Group prenatal care models have been demonstrated through rigorous research to provide significantly improved birth outcomes with implications for maternal-child health and substantial cost savings. However, group prenatal care is currently available to only a small fraction of the more than four million women who give birth annually in the US. Through the development, implementation and evaluation of a new model of group prenatal care, we will create an outcomes-focused model of group prenatal care that will be scalable nationally with an eye toward improving US birth outcomes. The long-term objective of the proposed study is to reduce the risk for adverse perinatal outcomes during and after pregnancy among women and families receiving prenatal care in health centers in 3 geographic locations serving vulnerable populations: Hidalgo County Texas, Nashville Tennessee, and Detroit Michigan. We will develop, disseminate, and evaluate a new and improved model of group prenatal care, "Expect with Me," based on our previous research on group models of prenatal care, which has already yielded favorable behavioral and biological results in two randomized controlled trials. We hypothesize that, relative to women who receive standard individual prenatal care, the women who receive "Expect with Me" group prenatal care will be significantly more likely to: have better perinatal outcomes, including better health behaviors during pregnancy (e.g., nutrition, physical activity), better birth outcomes (e.g., decreased preterm labor, low birthweight, Neonatal Intensive Care Unit stays), and better postpartum indicators (e.g., increased breastfeeding); report greater change in risk-related behaviors and psychosocial characteristics that could be considered potential mechanisms for the program's effectiveness; have lower rates of sexually transmitted diseases and rapid repeat pregnancy one year postpartum; have lower healthcare costs through improved outcomes (e.g., appropriate care utilization, fewer complications, reduced NICU admissions/length of stays) Comparisons based on propensity-score matched sample of women receiving standard individual prenatal care at the same clinical sites.
Detailed Description
This study addresses the intractable challenges of adverse birth outcomes, including preterm delivery and low birthweight, by proposing the development, implementation and evaluation of a model of group prenatal care that could be scaled nationally. Group prenatal care models have been demonstrated through rigorous research to provide significantly improved birth outcomes with implications for maternal-child health and substantial cost savings. However, group prenatal care is currently available to only a small fraction of the more than four million women who give birth annually in the US. Through the development, implementation and evaluation of a new model of group prenatal care, we will create an outcomes-focused model of group prenatal care that will be scalable nationally with an eye toward improving US birth outcomes. Specific Aims: The long-term objective of the proposed study is to reduce the risk for adverse perinatal outcomes during and after pregnancy among women and families receiving prenatal care in health centers in 3 geographic locations serving vulnerable populations: Hidalgo County Texas, Nashville Tennessee, and Detroit Michigan. We will develop, disseminate, and evaluate a new and improved model of group prenatal care, "Expect with Me," based on our previous research on group models of prenatal care, which has already yielded favorable behavioral and biological results in two randomized controlled trials. The overall objective of this project is to improve maternal health and reduce adverse birth outcomes. We will meet this objective by achieving three specific goals: Develop a new and improved model of group prenatal care, including curriculum, training materials, IT infrastructure and marketing materials to support broad adoption of group prenatal care, enhance consumer experience, monitor patient outcomes, and ensure national scalability. Implement group prenatal care in three communities at high risk for adverse perinatal outcomes (Hidalgo County TX, Nashville TN, Detroit MI), engaging and training providers in group facilitation and the established curriculum, engaging patients through improved in-reach and outreach strategies, and implementing IT infrastructure to improve uptake, patient experience, and sustainability through the monitoring of patient outcomes. Evaluate the effect of implementing group prenatal care through a rigorous process and outcome evaluation that identifies any barriers to national scalability and examines maternal health and birth outcomes and resultant cost implications. Specific Study Hypotheses We hypothesize that, relative to women who receive standard individual prenatal care, the women who receive "Expect with Me" group prenatal care will be significantly more likely to: have better perinatal outcomes, including better health behaviors during pregnancy (e.g., nutrition, physical activity), better birth outcomes (e.g., decreased preterm labor, low birthweight, Neonatal Intensive Care Unit stays), and better postpartum indicators (e.g., increased breastfeeding); report greater change in risk-related behaviors and psychosocial characteristics that could be considered potential mechanisms for the program's effectiveness; have lower rates of sexually transmitted diseases and rapid repeat pregnancy one year postpartum; have lower healthcare costs through improved outcomes (e.g., appropriate care utilization, fewer complications, reduced NICU admissions/length of stays)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Premature Birth, Infant, Low Birth Weight, Postpartum Period, Sexually Transmitted Diseases
Keywords
prenatal care, group care, Expect With Me, evaluation studies, group prenatal care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Expect With Me group prenatal care vs. Individual Care Only prenatal care
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2402 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Expect With Me group prenatal care
Arm Type
Experimental
Arm Description
receiving prenatal care through an Expect With Me group
Arm Title
Individual Care Only
Arm Type
Active Comparator
Arm Description
Standard of Care- individual prenatal care
Intervention Type
Behavioral
Intervention Name(s)
Expect With Me group prenatal care
Other Intervention Name(s)
group prenatal care
Intervention Description
Expect With Me group prenatal care was designed based on: principles of group care; evidence from RCTs demonstrating improved birth outcomes; ACOG clinical guidelines; and research on patient and provider engagement through technology. Designed with national dissemination as a primary consideration, Expect With Me incorporates best evidence-based aspects of existing models of group care, with a novel IT platform to improve patient engagement and support, enhance health behaviors and decision making, connect providers and patients, and improve health service delivery. Expect With Me provides care to groups of 8-12 women of the same gestational age, implemented after initial individual assessment through delivery. Group visits are 90-120 minutes each, and follow a structured curriculum that incorporates standard content of prenatal care, and emphasizes critical health issues relevant to pregnancy, such as nutrition, physical activity, stress/mental health and sexual health.
Intervention Type
Other
Intervention Name(s)
Standard individual prenatal care
Other Intervention Name(s)
Individual Care Only
Intervention Description
Standard of care- individual prenatal care
Primary Outcome Measure Information:
Title
Risk of preterm birth incidence
Description
Incidence risk of delivery before 37 weeks gestation
Time Frame
up to 37 weeks gestation
Title
Risk of low birth weight incidence
Description
Incidence risk of infant weight at birth < 2500 grams
Time Frame
delivery
Title
Risk of small for gestational age incidence
Description
Incidence risk of infant weight below the 10th percentile for the gestational age at birth
Time Frame
delivery
Title
Risk of neonatal intensive care unit (NICU) admission incidence
Description
Incidence risk of being admitted to the neonatal intensive care unit (NICU) at birth
Time Frame
birth
Secondary Outcome Measure Information:
Title
breastfeeding
Description
initiation and duration of breastfeeding
Time Frame
6 and 12 months postpartum
Title
nutrition
Description
nutritional choices, food security, and use of mindful eating practices
Time Frame
2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
Title
physical activity
Description
level of physical activity in a typical week
Time Frame
2nd and 3rd trimester and 6 and 12 months postpartum
Title
readiness for labor and delivery
Description
readiness for labor and delivery
Time Frame
measured at 2nd and third trimester
Title
readiness for taking care of baby
Description
readiness for taking care of baby
Time Frame
2nd and 3rd trimester of pregnancy
Title
social support
Description
multidimensional scale of perceived social support subscale
Time Frame
2nd and 3rd trimester and 6 and 12 months postpartum
Title
condom use self-efficacy
Description
condom use self efficacy scale
Time Frame
2nd and 3rd trimester and 6 and 12 months postpartum
Title
substance use
Description
use of cigarettes, alcohol, and drugs
Time Frame
2nd and 3rd trimester and 6 and 12 months postpartum
Title
care satisfaction
Description
satisfaction with Expect With Me group prenatal care and use of program components
Time Frame
3rd trimester
Title
adherence to medical recommendations
Description
adherence to medical recommendations (e.g., 6-week postpartum check, pediatric visits, vaccinations, infant feeding)
Time Frame
6 & 12 months postpartum
Title
postpartum body mass index
Description
individual's body weight divided by the square of their height (kg/m2)
Time Frame
measured at 6 and 12 months postpartum
Title
maternal weight gain
Description
weight gain as compared to medical recommendations
Time Frame
measured at 2nd and 3rd trimester and birth
Title
mode of delivery
Description
mode of delivery (e.g., cesarean, vaginal)
Time Frame
delivery
Title
sexual risk: condom use
Description
condom use percent (0-100%)
Time Frame
measured at 2nd and 3rd trimester and 6 and 12 months postpartum
Title
sexual risk: contraceptive use (LARC)
Description
use of other contraceptives to prevent pregnancy (no/yes)
Time Frame
measured at 2nd and 3rd trimester and 6 and 12 months postpartum
Title
sexual risk: number of sexual partners
Description
number of partners
Time Frame
measured at 2nd and 3rd trimester and 6 and 12 months postpartum
Title
sexual risk: sexually transmitted infection
Description
sexually transmitted infection (no/yes, during pregnancy or incident postpartum)
Time Frame
measured at 2nd and 3rd trimester and 6 and 12 months postpartum
Other Pre-specified Outcome Measures:
Title
nurse visitation
Description
participation in a nurse visitation program
Time Frame
2nd and 3rd trimester of pregnancy
Title
sexual debut
Description
age at first intercourse
Time Frame
2nd trimester pregnancy
Title
living situation
Description
where and with whom they live with and the stability of their housing
Time Frame
2nd and 3rd trimester and 6 and 12 months postpartum
Title
transfer of motivation
Description
relation of motivation for self and baby's health
Time Frame
2nd and3rd trimester and 6 and 12 months postpartum
Title
confidence in parenting skills
Description
confidence in parenting skills
Time Frame
6 and 12 months postpartum
Title
intimate partner violence
Description
perpetration and victimization of violence by an intimate partner
Time Frame
measured at 2nd and 3rd trimester and 6 and 12 months postpartum
Title
perceived stress
Description
stress level as reported by patient
Time Frame
2nd and 3rd trimester and 6 and 12 months postpartum
Title
depressive symptomatology
Description
patient endorsement of depressive symptoms
Time Frame
2nd and 3rd trimester of pregnancy
Title
perceived discrimination
Description
patient experiences of discrimination
Time Frame
2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
Title
resilience
Description
shift and persist scale
Time Frame
2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: less than 24 weeks pregnant able to attend groups conducted in English or Spanish consent to share their data with the study Exclusion Criteria: severe medical problem requiring individual care only, as determined by the participating clinical practice
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeannette R Ickovics, Ph.D.
Organizational Affiliation
Yale School of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jessica B Lewis, PhD, MFT
Organizational Affiliation
Yale School of Public Health
Official's Role
Study Director
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34678329
Citation
Lewis JB, Cunningham SD, Shabanova V, Hassan SS, Magriples U, Rodriguez MG, Ickovics JR. Group prenatal care and improved birth outcomes: Results from a type 1 hybrid effectiveness-implementation study. Prev Med. 2021 Dec;153:106853. doi: 10.1016/j.ypmed.2021.106853. Epub 2021 Oct 20.
Results Reference
derived
PubMed Identifier
28521785
Citation
Cunningham SD, Lewis JB, Thomas JL, Grilo SA, Ickovics JR. Expect With Me: development and evaluation design for an innovative model of group prenatal care to improve perinatal outcomes. BMC Pregnancy Childbirth. 2017 May 18;17(1):147. doi: 10.1186/s12884-017-1327-3.
Results Reference
derived

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Development of a Nationally Scalable Model of Group Prenatal Care to Improve Birth Outcomes: "Expect With Me"

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