Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application

One in ten births will occur prior to 37 weeks of gestation leading to serious complications such as problems with lung, heart and brain function and an increased risk of infant mortality. Solutions exist to treat risk factors related to preterm birth but these solutions require timely identification of the risks which is often not possible within regular prenatal care. This study will evaluate MyHealthyPregnancy, an application that monitors for common risks associated with preterm birth and recommends solutions to the expectant mother and care team.

Study Overview

• Status: Completed
• Conditions: Preterm Birth; Pregnancy Related
• Intervention / Treatment: Behavioral: MyHealthyPregnancy

Detailed Description

MyHealthyPregnancy (MHP) is an application that was developed using behavioral decision science principles. This study seeks to evaluate the effectiveness and efficacy of the application. MyHealthyPregnancy was offered to expectant mothers at the University of Pittsburgh Medical Center in conjunction with usual prenatal care. The primary objective is to compare the reduction in gestational age at birth between MHP and usual care cohorts. Secondary objectives include comparing births occurring prior to 37 weeks of gestation, depression rates, anxiety rates, referrals to behavioral health, referrals to social workers, preeclampsia rates, gestational weight gain, number of prenatal appointments attended, and percent of required prenatal appointments attended between the MHP and usual care cohorts.

• Study Type: Observational
• Enrollment (Actual): 12344

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant people offered a prescription for MyHealthyPregnancy who were at least 18 years of age, pregnant, received care at UPMC, and delivered at a UPMC hospital

Description

Inclusion Criteria:

• Offered a prescription for MyHealthyPregnancy
• 18+ years of age
• Pregnant
• Seeking care at a UPMC hospital
• Delivered at a UPMC hospital

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MyHealthyPregnancy (MHP); Use of the MyHealthyPregnancy application in conjunction with usual care.	Behavioral: MyHealthyPregnancy; MyHealthyPregnancy is a mobile application prescribed to expectant mothers in conjunction with normal prenatal care. The application uses behavioral decision science principles to identify risks of preterm birth and alert the mother and care team of these risks.
Usual Prenatal Care (usual care); Usual prenatal care consisting of biweekly visits with the patient care team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational Age at Birth	Gestational age at birth will be measured using each patients electronic health record. The average treatment effect will be calculated using linear regression comparing MHP and usual care cohorts. Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects gestational age at birth.	Baseline to 40 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prenatal Births	Occurrence of preterm birth will be measured using each patient's electronic health record. The likelihood of preterm birth between the MHP and usual care cohorts will be compared using logistic regression. Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects preterm birth.	Baseline to 37 Weeks
Depression Rates	Depression rates will be measured using diagnoses of depression in each patient's electronic health record. Depression rates between the MHP and usual care cohorts will be compared using linear regression. Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects depression rates.	Baseline to 40 Weeks
Anxiety Rates	Anxiety rates will be measured using diagnoses of anxiety in each patient's electronic health record. Anxiety rates between the MHP and usual care cohorts will be compared using linear regression. Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects anxiety rates.	Baseline to 40 Weeks
Referrals to Behavioral Health Specialists	Rates of referrals to behavioral health specialists will be measured using each patient's electronic health record. Rates in referrals between the MHP and usual care cohorts will be compared using linear regression. Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects rates of referrals.	Baseline to 40 Weeks
Referrals to Social Workers	Rates of referrals to social workers will be measured using each patient's electronic health record. Rates in referrals between the MHP and usual care cohorts will be compared using linear regression. Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects rates of referrals.	Baseline to 40 Weeks
Preeclampsia	Preeclampsia will be measured using each patient's electronic health record. Rates of preeclampsia between the MHP and usual care cohorts will be compared using linear regression. Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects preeclampsia.	Baseline to 40 Weeks
Gestational Weight Gain	Gestational weight gain will be measured by calculating the difference between each patient's initial weight and delivery weight recorded in their electronic health record. Gestational weight gain will be categorized as sufficient or insufficient according to 2009 Institute of Medicine guidelines. The likelihood of achieving sufficient gestational weight gain between the MHP and usual care cohorts will be compared using ordinal regression. Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects the likelihood of achieving sufficient gestational weight gain.	Baseline to 40 Weeks
Attendance at Prenatal Appointments	Number of prenatal visits attended will be measured using each patient's electronic health record. The number of visits attended between the MHP and usual care cohorts will be compared using linear regression. Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects attendance at prenatal visits.	Baseline to 40 Weeks
Attendance at Required Prenatal Appointments	The percent of required prenatal appointments attended will be measured using each patient's electronic health record. The percent of visits attended between the MHP and usual care cohorts will be compared using linear regression. Efficacy of the application will be assessed using a dose-response model to evaluate how use of the application affects attendance at prenatal visits.	Baseline to 40 Weeks

Collaborators and Investigators

• Sponsor: Naima Health LLC
• Collaborators: Carnegie Mellon University

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2019
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 12, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 1684

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Analytic Code
   Information comments: The analytic code will be uploaded to OSF upon publishing the manuscript.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No