NCT04300894

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,953

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

4.6 years

First QC Date

March 6, 2020

Last Update Submit

April 15, 2026

Conditions

Perinatal Depression

Outcome Measures

Primary Outcomes (1)

  • Change in depression symptom severity

    measured by the Edinburgh Postpartum Depression Scale

    Baseline to 6 months postpartum, about 11 months

Secondary Outcomes (3)

  • Change in subjective well-being

    Baseline to 6 months postpartum, about 11 months

  • Change in anxiety

    Baseline to 6 months postpartum, about 11 months

  • Change in stress

    Baseline to 6 months postpartum, about 11 months

Study Arms (3)

Usual care group

NO INTERVENTION

Usual prenatal and postpartum care involves regular visits with one's health care provider while pregnant and after the baby is born.

Mamma Mia group

EXPERIMENTAL

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

Device: Mamma Mia

Mamma Mia Plus group

EXPERIMENTAL

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

Device: Mamma MiaOther: Mamma Mia Plus

Interventions

Mamma MiaDEVICE

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 groupMamma Mia group
Mamma Mia PlusOTHER

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

Mamma Mia Plus group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • Kinser PA, Moyer S, Jones HA, Jallo N, Popoola A, Thacker L, Russell S, Olavesen ES, Sundrehagen T, Hare MM, Xia B, Garthus-Niegel S, Haga S, Drozd F. Perceptions of the Mamma Mia program, an internet-based prevention strategy for perinatal depression symptoms. PLOS Ment Health. 2025 Apr 3;2(4):e0000138. doi: 10.1371/journal.pmen.0000138. eCollection 2025.

    PMID: 41661763DERIVED

Study Officials

  • Patricia A Kinser, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 9, 2020

Study Start

October 15, 2020

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)