Mamma Mia App for Perinatal Wellness

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

1953 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

How does the Mamma Mia App treatment differ from other treatments for perinatal wellness?

The Mamma Mia App is unique because it leverages mobile technology to support perinatal wellness, focusing on user engagement and personalized content delivery, which is not typically a feature of traditional treatments. This app-based approach allows for continuous support and self-management, which can be more accessible and flexible for users compared to standard in-person interventions. ^{1 2 3 4 5}

What data supports the effectiveness of the Mamma Mia App for Perinatal Wellness treatment?

The research suggests that mobile health apps can be effective in supporting health-related behaviors during pregnancy and postpartum, such as managing weight and improving physical activity. This indicates that similar apps, like Mamma Mia, could potentially help with perinatal wellness by providing accessible and personalized support. ^{2 5 6 7 8}

Who Is on the Research Team?

Patricia Kinser, PhD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for pregnant women under 25 weeks gestation, aged 18 or older, who speak English and can access internet/mobile-based programs. They must have a working phone number and email address.

Inclusion Criteria

I can use the internet on a device and have a working phone and email.

speak, read, and understand English;

I am pregnant and less than 25 weeks along.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the 'Mamma Mia' program regularly and may receive regular contact from study staff

6 months

Regular use of app, occasional contact from study staff

Follow-up

Participants are monitored for changes in depression, well-being, anxiety, and stress

5 months

What Are the Treatments Tested in This Trial?

Interventions

• Mamma Mia
• Mamma Mia Plus

Trial Overview 'Mamma Mia' is an app designed to improve well-being during pregnancy and after birth. The study compares the standard 'Mamma Mia' program with 'Mamma Mia Plus,' which includes extra support from staff.

How Is the Trial Designed?

Group I: Mamma Mia group Experimental Treatment 1 Intervention

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

Group II: Mamma Mia Plus group Experimental Treatment 2 Interventions

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

Group III: Usual care group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

57% of postpartum patients reported using infant feeding tracker apps, with users more likely to have breastfed their infants, indicating that these apps may support breastfeeding practices.

Users of infant feeding tracker apps also engaged with more health apps overall, suggesting a trend towards increased health management among those who utilize these digital tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infant Feeding Tracker Applications: Cross-Sectional Analysis of Use. Dinour, LM.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Infant Feeding Tracker Applications: Cross-Sectional Analysis of Use. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of a Digital Intervention to Promote Healthy Weight Management among Postpartum African American/Black Women. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Are Pregnant and Postpartum Women Interested in Health-Related Apps? Implications for the Prevention of Perinatal Depression. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

SweetMama: Usability Assessment of a Novel Mobile Application Among Low-Income Pregnant People to Assist With Diabetes Management and Support. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

SmartMoms Canada: An evaluation of a mobile app intervention to support a healthy pregnancy. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Consumer Perspectives on Maternal and Infant Health Apps: Qualitative Content Analysis. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Consumer Engagement in Mobile Application (App) Interventions Focused on Supporting Infant Feeding Practices for Early Prevention of Childhood Obesity. [2020]

8. Canada pubmed.ncbi.nlm.nih.gov

Impact of a Mobile Application for Tracking Nausea and Vomiting During Pregnancy (NVP) on NVP Symptoms, Quality of Life, and Decisional Conflict Regarding NVP Treatments: MinSafeStart Randomized Controlled Trial. [2022]