"Mamma Mia" for Perinatal Health and Wellness

The purpose of this research study is to find out about ways to enhance well-being during pregnancy and the postpartum period (after the baby is born). The "Mamma Mia" program and/or guided support from study staff ("Mamma Mia Plus") may be helpful because the app provides skills and information related to many important topics during and after pregnancy. This study will allow us to learn more about whether and how the program is helpful to women.

Study Overview

• Status: Active, not recruiting
• Conditions: Perinatal Depression
• Intervention / Treatment: Device: Mamma Mia; Other: Mamma Mia Plus

Detailed Description

This study will compare findings in women who do not use the program ("usual care group") versus women who use the program ("Mamma Mia group") versus women who use the program and receive regular contact from study staff ("Mamma Mia Plus"). The study will assess well-being, depression, stress, and anxiety as well as whether certain factors (for example, women's age, type of healthcare provider, amount of social support) are related to the effects of the program. For women randomized to use the program, the study will also collect information about the time spent using it and the modules completed.

Usual prenatal and postpartum care involves regular visits with participant's women's health care provider while pregnant and after the baby is born. In this study, participants will receive continue receiving usual care. In addition, participants will be randomly assigned (like the flip of a coin) to participate in one of the following groups:

1. The "usual care group", or
2. The "Mamma Mia group" (which is to use the "Mamma Mia" program regularly), or
3. The "Mamma Mia Plus group" (which is to use the program regularly plus receive regular contact with study staff).

There is a 1 chance in 3 of being assigned to each of the three groups. participants have an equal chance of being assigned to any one of the groups.

Participants in the "usual care group" will be asked to do the following things:

1. Complete survey questions at entrance into the study.
2. Complete survey questions every few months (see schedule below).

Participants in the "Mamma Mia group" will be asked to do the following things:

1. Complete survey questions at entrance into the study.
2. Use the "Mamma Mia" program on a regular basis (on average: weekly for about 10 minutes) from entering study until six months postpartum; participants will receive an email reminder to complete modules when they should be completed.
3. Complete survey questions every few months.

Participants in the "Mamma Mia Plus group" will be asked to do the following things:

1. Complete survey questions at entrance into the study.
2. Use the "Mamma Mia" program on a regular basis (on average: weekly for about 10 minutes) from entrance into the study until six months postpartum.
3. Complete survey questions every few months.
4. Participants will receive phone calls or emails or texts (depending upon participant preference) from study staff every few months.

• Study Type: Interventional
• Enrollment (Actual): 1952
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• pregnant woman <25 weeks gestation;
• age 18 or older;
• speak, read, and understand English;
• have the ability to access an internet/mobile-based program (via computer, tablet, or smartphone), and have a working phone number and a working email address.

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care group; Usual prenatal and postpartum care involves regular visits with one's health care provider while pregnant and after the baby is born.
Experimental: Mamma Mia group; Usual prenatal/postpartum care plus use of the "Mamma Mia" program	Device: Mamma Mia; Users of the Mamma Mia program progress through the intervention in a sequence of modules. Every day that a module should be completed, you will receive a notification with a reminder to access the program. By clicking on the reminder, you can access that particular day's session content. Modules involve a variety of information and activities; for example, there are guided mindfulness practices, information on breastfeeding, instructional videos on how to interpret your baby's cries, and discussions on how to have effective discussions with your partner or healthcare provider about your needs.
Experimental: Mamma Mia Plus group; Usual prenatal/postpartum care plus use of the "Mamma Mia" program plus occasional contacts from study staff	Device: Mamma Mia; Users of the Mamma Mia program progress through the intervention in a sequence of modules. Every day that a module should be completed, you will receive a notification with a reminder to access the program. By clicking on the reminder, you can access that particular day's session content. Modules involve a variety of information and activities; for example, there are guided mindfulness practices, information on breastfeeding, instructional videos on how to interpret your baby's cries, and discussions on how to have effective discussions with your partner or healthcare provider about your needs.; Other: Mamma Mia Plus; Participants will use the Mamma Mia program, plus receive contact (phone calls or emails or texts) from study staff every few months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depression symptom severity	measured by the Edinburgh Postpartum Depression Scale	Baseline to 6 months postpartum, about 11 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in subjective well-being	Measured using Satisfaction with Life Scale	Baseline to 6 months postpartum, about 11 months
Change in anxiety	Measured by the State-Trait Anxiety Scale	Baseline to 6 months postpartum, about 11 months
Change in stress	Measured by the Perceived Stress Scale	Baseline to 6 months postpartum, about 11 months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Patricia A Kinser, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: HM20017197; 1R01HD100395 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No