Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 7:22 AM
Study NCT ID:
NCT04300894
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2020-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Mamma Mia" for Perinatal Health and Wellness
Sponsor:
Virginia Commonwealth University
Organization:
Study Overview
Official Title:
"Mamma Mia" for Perinatal Health and Wellness
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01HD100395 | NIH | None | https://reporter.nih.gov/quic… | View |