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| Name | Class |
|---|---|
| United Health Foundation | UNKNOWN |
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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:
Comparisons based on propensity-score matched sample of women receiving standard individual prenatal care at the same clinical sites.
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Expect With Me group prenatal care | Experimental | receiving prenatal care through an Expect With Me group |
|
| Individual Care Only | Active Comparator | Standard of Care- individual prenatal care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expect With Me group prenatal care | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Risk of preterm birth incidence | Incidence risk of delivery before 37 weeks gestation | up to 37 weeks gestation |
| Risk of low birth weight incidence | Incidence risk of infant weight at birth < 2500 grams | delivery |
| Risk of small for gestational age incidence | Incidence risk of infant weight below the 10th percentile for the gestational age at birth | delivery |
| Risk of neonatal intensive care unit (NICU) admission incidence | Incidence risk of being admitted to the neonatal intensive care unit (NICU) at birth | birth |
| Measure | Description | Time Frame |
|---|---|---|
| breastfeeding | initiation and duration of breastfeeding | 6 and 12 months postpartum |
| nutrition | nutritional choices, food security, and use of mindful eating practices |
| Measure | Description | Time Frame |
|---|---|---|
| nurse visitation | participation in a nurse visitation program | 2nd and 3rd trimester of pregnancy |
| sexual debut | age at first intercourse | 2nd trimester pregnancy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeannette R Ickovics, Ph.D. | Yale School of Public Health | Principal Investigator |
| Jessica B Lewis, PhD, MFT | Yale School of Public Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wayne State University | Detroit | Michigan | 48201 | United States | ||
| Vanderbilt University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38439113 | Derived | Masters C, Carandang RR, Lewis JB, Hagaman A, Metrick R, Ickovics JR, Cunningham SD. Group prenatal care successes, challenges, and frameworks for scaling up: a case study in adopting health care innovations. Implement Sci Commun. 2024 Mar 4;5(1):20. doi: 10.1186/s43058-024-00556-1. | |
| 34678329 | Derived | 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. |
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Expect With Me group prenatal care vs. Individual Care Only prenatal care
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|
|
| Standard individual prenatal care | Other | Standard of care- individual prenatal care |
|
|
| 2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum |
| physical activity | level of physical activity in a typical week | 2nd and 3rd trimester and 6 and 12 months postpartum |
| readiness for labor and delivery | readiness for labor and delivery | measured at 2nd and third trimester |
| readiness for taking care of baby | readiness for taking care of baby | 2nd and 3rd trimester of pregnancy |
| social support | multidimensional scale of perceived social support subscale | 2nd and 3rd trimester and 6 and 12 months postpartum |
| condom use self-efficacy | condom use self efficacy scale | 2nd and 3rd trimester and 6 and 12 months postpartum |
| substance use | use of cigarettes, alcohol, and drugs | 2nd and 3rd trimester and 6 and 12 months postpartum |
| care satisfaction | satisfaction with Expect With Me group prenatal care and use of program components | 3rd trimester |
| adherence to medical recommendations | adherence to medical recommendations (e.g., 6-week postpartum check, pediatric visits, vaccinations, infant feeding) | 6 & 12 months postpartum |
| postpartum body mass index | individual's body weight divided by the square of their height (kg/m2) | measured at 6 and 12 months postpartum |
| maternal weight gain | weight gain as compared to medical recommendations | measured at 2nd and 3rd trimester and birth |
| mode of delivery | mode of delivery (e.g., cesarean, vaginal) | delivery |
| sexual risk: condom use | condom use percent (0-100%) | measured at 2nd and 3rd trimester and 6 and 12 months postpartum |
| sexual risk: contraceptive use (LARC) | use of other contraceptives to prevent pregnancy (no/yes) | measured at 2nd and 3rd trimester and 6 and 12 months postpartum |
| sexual risk: number of sexual partners | number of partners | measured at 2nd and 3rd trimester and 6 and 12 months postpartum |
| sexual risk: sexually transmitted infection | sexually transmitted infection (no/yes, during pregnancy or incident postpartum) | measured at 2nd and 3rd trimester and 6 and 12 months postpartum |
| living situation | where and with whom they live with and the stability of their housing | 2nd and 3rd trimester and 6 and 12 months postpartum |
| transfer of motivation | relation of motivation for self and baby's health | 2nd and3rd trimester and 6 and 12 months postpartum |
| confidence in parenting skills | confidence in parenting skills | 6 and 12 months postpartum |
| intimate partner violence | perpetration and victimization of violence by an intimate partner | measured at 2nd and 3rd trimester and 6 and 12 months postpartum |
| perceived stress | stress level as reported by patient | 2nd and 3rd trimester and 6 and 12 months postpartum |
| depressive symptomatology | patient endorsement of depressive symptoms | 2nd and 3rd trimester of pregnancy |
| perceived discrimination | patient experiences of discrimination | 2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum |
| resilience | shift and persist scale | 2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum |
| Nashville |
| Tennessee |
| 37232 |
| United States |
| 28521785 | Derived | 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. |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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