"Mamma Mia" for Perinatal Health and Wellness

NCT ID: NCT04300894

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1953 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2025-06-01

Brief Summary

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.

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.

Conditions

Perinatal Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Mamma Mia group

Usual prenatal/postpartum care plus use of the "Mamma Mia" program

Group Type: EXPERIMENTAL

Mamma Mia

Intervention Type: DEVICE

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.

Mamma Mia Plus group

Usual prenatal/postpartum care plus use of the "Mamma Mia" program plus occasional contacts from study staff

Group Type: EXPERIMENTAL

Mamma Mia

Intervention Type: DEVICE

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.

Mamma Mia Plus

Intervention Type: OTHER

Participants will use the Mamma Mia program, plus receive contact (phone calls or emails or texts) from study staff every few months.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia A Kinser, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01HD100395

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM20017197

Identifier Type: -

Identifier Source: org_study_id