The Momba Mobile Application-based Community (MOMBA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01816945|
Recruitment Status : Completed
First Posted : March 22, 2013
Last Update Posted : May 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mental Health Wellness 1||Behavioral: MOMBA web-based application||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||The Momba Mobile Application-based Community|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||September 2015|
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.
Behavioral: MOMBA web-based application
Web-based, interactive, social network application.
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.
- Feasibility, acceptability, and methodological parameters [ Time Frame: 15 months ]To determine, through a 15-month pilot randomized controlled trial, the potential feasibility, acceptability, and methodological parameters (proportion of eligible and willing study participants, rate of subject attrition, effect size, and power calculations) that are necessary to design a subsequent, appropriately powered, randomized controlled trial of Momba for new mothers.
- Test the proper operating and functioning of the MOMBA application [ Time Frame: 15 months ]To develop through a 15-month pilot study, a novel application, Momba, to promote mental health among low-income mothers recruited from a large, urban hospital. Subjects will be trained (together) on the operating and functions (including how to use the privacy settings) of the Momba application.
- Acceptability and performance of structured questionnaires [ Time Frame: 15 months ]Via 15 months of application participation, we will assess the acceptability and performance of structured questionnaires in the categories of maternal satisfaction, utilization of intervention and adherence to protocol. Measures will be administered via the web- based application utilizing valid and reliable instruments. Participants will also complete Intake and 12 month Follow-up interviews.
- Improve maternal emotional health [ Time Frame: 15 months ]
Improve maternal emotional health, as measured by any/all of the following:
- increased social support, social networks, and social capital of low-income mothers
- positive change in measurable health behaviors
- utilization of health services
- mental health status of both mothers and their infants.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816945
|United States, Connecticut|
|Yale School of Medicine|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Megan V Smith, DrPH||Yale School of Medicine|