- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01816945
The Momba Mobile Application-based Community (MOMBA)
April 26, 2021 updated by: Yale University
The investigators' mobile application-based community, termed Momba, will provide a bi-directional flow of information on maternal and infant mental health to traditionally underrepresented groups of mothers and their infants.
The overall goal of this mobile application-based community of low-income postpartum women and infants is to increase the social support, social networks, and social capital of low-income mothers; thereby, leading to a positive change in the health behaviors, utilization of health services, and mental health status of both mothers and their infants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale School of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women will be recruited in their third trimester of pregnancy from Yale-New Haven Hospital (YNHH) and followed for 8 months postpartum.
- Women are eligible if they are over the age of 18, in their third trimester of pregnancy, will deliver a baby at YNHH and receive prenatal care at the Women's Center.
- Meet criteria for minor or major depressive disorder.
Exclusion Criteria:
- Mothers are not eligible to participate if they have previously given birth
- Are placing the baby for adoption
- Are planning to move in the next 18 months
- Are actively suicidal, psychotic or unable to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Access to MOMBA web-based application
Study will provide the subject with a smartphone, pay the data plan, and facilitate access to the web-based application for purposes of researching the acceptability of the application, the operating and functioning of it, and its impact on maternal mental health.
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Web-based, interactive, social network application.
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No Intervention: Smartphone only
Study will provide the subject with a smartphone and pay the data plan.
Weekly assessments are completed through internet survey links sent via text message.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Phone Retention
Time Frame: 15 months
|
To determine the potential feasibility of providing smartphones to participants and delivering and intervention through the smartphone, phone retention was measured.
Phone retention was defined as the ability of participants to retain the phone over the study period.
Outcome measure used was how many participants did not need a replacement phone during the study period.
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15 months
|
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Test the Proper Operating and Functioning of the MOMBA Application
Time Frame: Baseline
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To Test the proper operating and functioning of the MOMBA application, the number of participants that received training was assessed.
Intervention subjects were trained (together) on the operating and functions (including how to use the privacy settings) of the Momba application and the phone.
The control subjects were trained (together) on how to complete the control questionnaires and how to use the phone.
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Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability and Performance of Structured Questionnaires
Time Frame: 12 months
|
To determine the acceptability and performance of structured questionnaires, the measurement is categorized into whether participants did or did not complete the 12 month follow-up interview.
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12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health
Time Frame: 12 months
|
Improve maternal emotional health, was measured by the PHQ-9.
The Patient Health Questionnaire (PHQ-9) is a 9 item questionnaire that is used to assess depression severity.
The scores range from 0-27.
A score of 10 or higher can be indicative of a moderate - severe level of depression severity.
|
12 months
|
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Confident Network Score
Time Frame: 12 months
|
To assess the improvement maternal emotional health, the Kendler Social Support Interview was used.
The Kendler Social Support Interview has scores that range from 0-5, with 5 indicating a larger social network or confidant network size.
Presented below are the confident network score at 12 month follow-up.
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12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Megan V Smith, DrPH, Yale School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
February 26, 2013
First Submitted That Met QC Criteria
March 19, 2013
First Posted (Estimate)
March 22, 2013
Study Record Updates
Last Update Posted (Actual)
May 18, 2021
Last Update Submitted That Met QC Criteria
April 26, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1207010574
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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