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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD100395 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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:
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:
Participants in the "Mamma Mia group" will be asked to do the following things:
Participants in the "Mamma Mia Plus group" will be asked to do the following things:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Mamma Mia Plus group | Experimental | Usual prenatal/postpartum care plus use of the "Mamma Mia" program plus occasional contacts from study staff |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mamma Mia | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depression Symptom Severity | 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. | Baseline to 6 months postpartum, about 11 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Subjective Well-being | 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. | Baseline to 6 months postpartum, about 11 months |
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Inclusion Criteria:
Exclusion Criteria:
• none
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| Name | Affiliation | Role |
|---|---|---|
| Patricia A Kinser, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41661763 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Mamma Mia Group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Depression Symptom Severity | 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. | Not all participants answered all questions at every timepoint. GA-gestational age during pregnancy, PP-postpartum | Posted | Mean | Standard Deviation | score on EPDS | Baseline to 6 months postpartum, about 11 months |
Baseline through 6 months postpartum (approx 11 months)
We defined a serious adverse event as endorsement of suicidality on study questionnaires related to the intervention. There were no reports of suicidality related to the intervention throughout the entirety of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia Kinser, Principal Investigator | Virginia Commonwealth University | 804-828-0724 | kinserpa@vcu.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 5, 2025 | Jun 29, 2026 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 1, 2021 | Jul 22, 2025 | ICF_000.pdf |
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| Mamma Mia Plus | Other | 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 | 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. | Baseline to 6 months postpartum, about 11 months |
| Change in Anxiety | 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 | Baseline to 12 week post-postpartum |
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.
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Only females were enrolled since only pregnant/postpartum persons eligible. | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | 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. |
| OG001 | 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. |
| OG002 | 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. |
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| Secondary | Change in Subjective Well-being | 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. | Not all participants answered all questions at every timepoint. GA-gestational age during pregnancy, PP-postpartum | Posted | Mean | Standard Deviation | score on a SWLS | Baseline to 6 months postpartum, about 11 months |
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| Secondary | Change in Stress | 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. | Not all participants answered all questions at every timepoint. GA-gestational age during pregnancy, PP-postpartum. | Posted | Mean | Standard Deviation | score on PASS | Baseline to 6 months postpartum, about 11 months |
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|
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| Secondary | Change in Anxiety | 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 | Not all participants answered all questions at every timepoint. GA-gestational age during pregnancy, PP-postpartum. | Posted | Mean | Standard Deviation | score on PASS | Baseline to 12 week post-postpartum |
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|
| 0 |
| 586 |
| 0 |
| 586 |
| 0 |
| 586 |
| EG001 | 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. | 0 | 585 | 0 | 585 | 0 | 585 |
| EG002 | 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. | 0 | 586 | 0 | 586 | 0 | 586 |
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| 37 weeks GA |
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| 6 weeks PP |
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| 12 weeks PP |
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| 24 weeks PP |
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| 37 weeks GA |
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| 6 weeks PP |
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| 12 weeks PP |
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| 24 weeks PP |
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| 37 weeks GA |
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| 6 weeks PP |
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| 12 weeks PP |
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