Mental Health Wellness 1MOMBANCT01816945
The Momba Mobile Application-based Community
A study testing MOMBA web-based application in people with Mental Health Wellness 1, run by Yale University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- MOMBA web-based application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06510
About this study
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.
- Conditions
- Mental Health Wellness 1
- Being tested
- MOMBA web-based application
- Keywords
- Depression, Stress, Social support, Social capital, Maternal
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOMBA web-based applicationBehavioural
Web-based, interactive, social network application.
| Study group | Role | What they receive |
|---|---|---|
| Access to MOMBA web-based application | Experimental | 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. Receives: Behavioral: MOMBA web-based application |
| Smartphone only | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Phone Retention
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.
Measured: 15 months
Test the Proper Operating and Functioning of the MOMBA Application
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.
Measured: Baseline
Secondary outcomes (1)
Acceptability and Performance of Structured Questionnaires
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Megan V Smith, DrPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816945
- Sponsor's protocol ID
- 1207010574
- Acronym
- MOMBA
- Status last verified
- Apr 2021
- First submitted
- 26 Feb 2013
- Last updated
- 18 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Momba Mobile Application-based Community
- ClinicalTrials.gov ID
- NCT01816945
- Acronym / sponsor ID
- MOMBA / 1207010574
- Conditions
- Mental Health Wellness 1
- Keywords
- Depression, Stress, Social support, Social capital, Maternal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 Mar 2013 (estimated)
- Results
- Posted 18 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Access to MOMBA web-based application | Experimental | Behavioral: MOMBA web-based applicationStudy 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. |
| Smartphone only | No intervention | –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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOMBA web-based applicationWeb-based, interactive, social network application. | Behavioural | Access to MOMBA web-based application |
Primary outcome
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.
Test the Proper Operating and Functioning of the MOMBA Application
Time frame: Baseline
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.
1 secondary outcome
Acceptability and Performance of Structured Questionnaires
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Mental Health Wellness 1
Not yet recruiting
A Virtual Reality Program for Nursing Home Residents With Physical Disabilities
Older Adults Institutionalized in Residential Homes
Recruiting
GUT-FEELINGS: Using Citizen Science for Large-Scale Prebiotic Clinical Trials for Mental Wellness in Adults
Sleep Disturbance, Stress
Not yet recruitingPhase 1
A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults
Schizophrenia
Not yet recruiting
Online Intervention To Improve Motivation
Schizophrenia Prodromal, SCHIZOPHRENIA 1 (Disorder)
Not yet recruiting
Cognitive Intervention for Children and Adolescents With NF1
Neurofibromatosis 1 (NF1), Executive Function (Cognition)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan V Smith, DrPH principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOMBA web-based application in people with Mental Health Wellness 1, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phone Retention (time frame: 15 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.