Clinical trial NCT04300894: "Mamma Mia" for Perinatal Health and Wellness
Official title: "Mamma Mia" for Perinatal Health and Wellness
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Perinatal Depression
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-03-09
Enrollment: 1953
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in depression symptom severity
timeFrame: Baseline to 6 months postpartum, about 11 months
Secondary outcomes:
measure: Change in subjective well-being
timeFrame: Baseline to 6 months postpartum, about 11 months
measure: Change in anxiety
timeFrame: Baseline to 6 months postpartum, about 11 months
measure: Change in stress
timeFrame: Baseline to 6 months postpartum, about 11 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Patricia A Kinser, PhD
role: PRINCIPAL_INVESTIGATOR
References: