Trial Outcomes & Findings for "Mamma Mia" for Perinatal Health and Wellness (NCT NCT04300894)
NCT ID: NCT04300894
Last Updated: 2026-07-02
Results Overview
Measured by the Edinburgh Postpartum Depression Scale (EPDS), it uses a 10-item self-report questionnaire that screens for symptoms of depression and anxiety during pregnancy and the first year postpartum. Mothers are asked to select the answer that comes closest to how they have felt over the past 7 days. Each of the 10 questions is scored from 0 to 3, yielding a maximum total score of 30. Some questions (items 3, 5, 6, 7, 8, 9, 10) are reverse-scored (e.g., 3, 2, 1, 0 instead of 0, 1, 2, 3). 0-9 (minimal to no symptoms): Indicates some distress that is likely short-lived. Monitoring is usually recommended if symptoms persist. 10-12 (Mild Distress): Indicates discomforting symptoms. Healthcare providers often suggest a repeat screen in 2 weeks. 13 or higher (Probable depression): Scores at or above this threshold typically signify a positive screen. Further clinical evaluation and potential referral to a mental health professional are strongly recommended.
COMPLETED
NA
1757 participants
Baseline to 6 months postpartum, about 11 months
2026-07-02
Participant Flow
Participant milestones
| Measure |
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.
|
Mamma Mia Group
Usual prenatal/postpartum care plus use of the "Mamma Mia" program
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.
|
Mamma Mia Plus Group
Usual prenatal/postpartum care plus use of the "Mamma Mia" program plus occasional contacts from study staff
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.
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
586
|
585
|
586
|
|
Overall Study
COMPLETED
|
586
|
585
|
586
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
"Mamma Mia" for Perinatal Health and Wellness
Baseline characteristics by cohort
| Measure |
Usual Care Group
n=586 Participants
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
n=585 Participants
Usual prenatal/postpartum care plus use of the "Mamma Mia" program
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.
|
Mamma Mia Plus Group
n=586 Participants
Usual prenatal/postpartum care plus use of the "Mamma Mia" program plus occasional contacts from study staff
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.
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.
|
Total
n=1757 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
56 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
586 participants
n=20 Participants
|
585 participants
n=20 Participants
|
586 participants
n=40 Participants
|
1757 participants
n=5 Participants
|
|
Age, Customized
Age (mean SD))
|
31.14 years
STANDARD_DEVIATION 4.73 • n=20 Participants
|
30.40 years
STANDARD_DEVIATION 4.49 • n=20 Participants
|
30.64 years
STANDARD_DEVIATION 4.64 • n=40 Participants
|
30.73 years
STANDARD_DEVIATION 4.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
586 Participants
n=20 Participants
|
585 Participants
n=20 Participants
|
586 Participants
n=40 Participants
|
1757 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
27 Participants
n=20 Participants
|
26 Participants
n=20 Participants
|
34 Participants
n=40 Participants
|
87 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
103 Participants
n=20 Participants
|
104 Participants
n=20 Participants
|
90 Participants
n=40 Participants
|
297 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
386 Participants
n=20 Participants
|
378 Participants
n=20 Participants
|
396 Participants
n=40 Participants
|
1160 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
49 Participants
n=20 Participants
|
54 Participants
n=20 Participants
|
43 Participants
n=40 Participants
|
146 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 months postpartum, about 11 monthsPopulation: Not all participants answered all questions at every timepoint. GA-gestational age during pregnancy, PP-postpartum
Measured by the Edinburgh Postpartum Depression Scale (EPDS), it uses a 10-item self-report questionnaire that screens for symptoms of depression and anxiety during pregnancy and the first year postpartum. Mothers are asked to select the answer that comes closest to how they have felt over the past 7 days. Each of the 10 questions is scored from 0 to 3, yielding a maximum total score of 30. Some questions (items 3, 5, 6, 7, 8, 9, 10) are reverse-scored (e.g., 3, 2, 1, 0 instead of 0, 1, 2, 3). 0-9 (minimal to no symptoms): Indicates some distress that is likely short-lived. Monitoring is usually recommended if symptoms persist. 10-12 (Mild Distress): Indicates discomforting symptoms. Healthcare providers often suggest a repeat screen in 2 weeks. 13 or higher (Probable depression): Scores at or above this threshold typically signify a positive screen. Further clinical evaluation and potential referral to a mental health professional are strongly recommended.
Outcome measures
| Measure |
Usual Care Group
n=586 Participants
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
n=585 Participants
Usual prenatal/postpartum care plus use of the "Mamma Mia" program
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.
|
Mamma Mia Plus Group
n=586 Participants
Usual prenatal/postpartum care plus use of the "Mamma Mia" program plus occasional contacts from study staff
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.
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.
|
|---|---|---|---|
|
Change in Depression Symptom Severity
Baseline=25 weeks GA
|
6.9 score on EPDS
Standard Deviation 4.45
|
6.9 score on EPDS
Standard Deviation 4.67
|
7.3 score on EPDS
Standard Deviation 4.88
|
|
Change in Depression Symptom Severity
37 weeks GA
|
7.0 score on EPDS
Standard Deviation 4.62
|
5.8 score on EPDS
Standard Deviation 4.29
|
5.9 score on EPDS
Standard Deviation 4.43
|
|
Change in Depression Symptom Severity
6 weeks PP
|
6.4 score on EPDS
Standard Deviation 4.89
|
5.5 score on EPDS
Standard Deviation 4.71
|
5.6 score on EPDS
Standard Deviation 4.72
|
|
Change in Depression Symptom Severity
12 weeks PP
|
6.5 score on EPDS
Standard Deviation 4.54
|
5.6 score on EPDS
Standard Deviation 4.52
|
5.3 score on EPDS
Standard Deviation 4.56
|
|
Change in Depression Symptom Severity
24 weeks PP
|
6.7 score on EPDS
Standard Deviation 4.88
|
5.8 score on EPDS
Standard Deviation 5.22
|
5.8 score on EPDS
Standard Deviation 5.76
|
SECONDARY outcome
Timeframe: Baseline to 6 months postpartum, about 11 monthsPopulation: Not all participants answered all questions at every timepoint. GA-gestational age during pregnancy, PP-postpartum
Measured using Satisfaction with Life Scale (SWLS). It consists of five items, and each is scored on a Likert scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"), and is presented in raw scores, with a total score range of 5 to 35. Higher scores indicate greater life satisfaction.
Outcome measures
| Measure |
Usual Care Group
n=586 Participants
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
n=585 Participants
Usual prenatal/postpartum care plus use of the "Mamma Mia" program
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.
|
Mamma Mia Plus Group
n=586 Participants
Usual prenatal/postpartum care plus use of the "Mamma Mia" program plus occasional contacts from study staff
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.
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.
|
|---|---|---|---|
|
Change in Subjective Well-being
Baseline = 25 weeks GA
|
28.3 score on a SWLS
Standard Deviation 5.54
|
28.4 score on a SWLS
Standard Deviation 5.69
|
27.9 score on a SWLS
Standard Deviation 5.83
|
|
Change in Subjective Well-being
37 weeks GA
|
28.8 score on a SWLS
Standard Deviation 5.49
|
29.7 score on a SWLS
Standard Deviation 5.03
|
29.4 score on a SWLS
Standard Deviation 4.92
|
|
Change in Subjective Well-being
6 weeks PP
|
29.1 score on a SWLS
Standard Deviation 5.08
|
29.4 score on a SWLS
Standard Deviation 5.18
|
29.3 score on a SWLS
Standard Deviation 5.26
|
|
Change in Subjective Well-being
12 weeks PP
|
29.3 score on a SWLS
Standard Deviation 4.90
|
29.3 score on a SWLS
Standard Deviation 5.29
|
29.1 score on a SWLS
Standard Deviation 5.42
|
|
Change in Subjective Well-being
24 weeks PP
|
24.1 score on a SWLS
Standard Deviation 4.08
|
25.2 score on a SWLS
Standard Deviation 4.10
|
25.2 score on a SWLS
Standard Deviation 4.00
|
SECONDARY outcome
Timeframe: Baseline to 6 months postpartum, about 11 monthsPopulation: Not all participants answered all questions at every timepoint. GA-gestational age during pregnancy, PP-postpartum.
Measured by the Perceived Stress Scale (PSS) which is a classic, widely used psychological questionnaire that evaluates the degree to which an individual views their life as unpredictable, uncontrollable, and overloaded over the past month. Scores on the 10-item version range from 0 to 40: 0-13 Low perceived stress, 14-26: Moderate perceived stress, and 27-40 High perceived stress.
Outcome measures
| Measure |
Usual Care Group
n=586 Participants
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
n=585 Participants
Usual prenatal/postpartum care plus use of the "Mamma Mia" program
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.
|
Mamma Mia Plus Group
n=586 Participants
Usual prenatal/postpartum care plus use of the "Mamma Mia" program plus occasional contacts from study staff
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.
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.
|
|---|---|---|---|
|
Change in Stress
Baseline = 25 weeks GA
|
6.9 score on PASS
Standard Deviation 4.45
|
6.9 score on PASS
Standard Deviation 4.67
|
7.3 score on PASS
Standard Deviation 4.88
|
|
Change in Stress
37 weeks GA
|
7.0 score on PASS
Standard Deviation 4.62
|
5.8 score on PASS
Standard Deviation 4.29
|
5.9 score on PASS
Standard Deviation 4.43
|
|
Change in Stress
6 weeks PP
|
6.4 score on PASS
Standard Deviation 4.89
|
5.5 score on PASS
Standard Deviation 4.71
|
5.6 score on PASS
Standard Deviation 4.72
|
|
Change in Stress
12 weeks PP
|
6.5 score on PASS
Standard Deviation 4.54
|
5.6 score on PASS
Standard Deviation 4.52
|
5.3 score on PASS
Standard Deviation 4.56
|
|
Change in Stress
24 weeks PP
|
6.7 score on PASS
Standard Deviation 4.88
|
5.8 score on PASS
Standard Deviation 5.22
|
5.8 score on PASS
Standard Deviation 5.76
|
SECONDARY outcome
Timeframe: Baseline to 12 week post-postpartumPopulation: Not all participants answered all questions at every timepoint. GA-gestational age during pregnancy, PP-postpartum.
Measured by the Perinatal Anxiety Screening Scale (PASS). The scale runs from 0-93, severity of perinatal anxiety symptoms are considered within the following score ranges: minimal anxiety (score 0-20); mild-moderate anxiety (score 21-41); and severe anxiety (score 41-93). A score of 26 or higher on the 31-item Perinatal Anxiety Screening Scale (PASS) is the standard clinical cut-off. A score at or above this threshold indicates the individual is at high risk for presenting with an anxiety disorder and may require further clinical evaluation. A score lower than 26 indicates minimal or mild anxiety and would not indicate further clinical evaluation. This was not administered in the late postpartum data collection timepoint, due to the lack of relevance of many items to that timepoint. The scale runs from 0-93
Outcome measures
| Measure |
Usual Care Group
n=586 Participants
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
n=585 Participants
Usual prenatal/postpartum care plus use of the "Mamma Mia" program
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.
|
Mamma Mia Plus Group
n=586 Participants
Usual prenatal/postpartum care plus use of the "Mamma Mia" program plus occasional contacts from study staff
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.
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.
|
|---|---|---|---|
|
Change in Anxiety
Baseline = 25 weeks GA
|
20.4 score on PASS
Standard Deviation 14.69
|
21.1 score on PASS
Standard Deviation 15.80
|
21.7 score on PASS
Standard Deviation 15.43
|
|
Change in Anxiety
37 weeks GA
|
20.6 score on PASS
Standard Deviation 15.38
|
16.8 score on PASS
Standard Deviation 13.87
|
18.1 score on PASS
Standard Deviation 13.22
|
|
Change in Anxiety
6 weeks PP
|
19.2 score on PASS
Standard Deviation 15.40
|
16.0 score on PASS
Standard Deviation 14.61
|
16.9 score on PASS
Standard Deviation 14.32
|
|
Change in Anxiety
12 weeks PP
|
18.7 score on PASS
Standard Deviation 15.27
|
17.0 score on PASS
Standard Deviation 15.19
|
16.5 score on PASS
Standard Deviation 12.12
|
Adverse Events
Usual Care Group
Mamma Mia Group
Mamma Mia Plus Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Patricia Kinser, Principal Investigator
Virginia Commonwealth University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place