Trial Outcomes & Findings for The Momba Mobile Application-based Community (NCT NCT01816945)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

47 participants

Primary outcome timeframe

15 months

Results posted on

2021-05-18

Participant Flow

Participant milestones

Participant milestones
Measure	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. MOMBA web-based application: Web-based, interactive, social network application.	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.
Overall Study STARTED	23	24
Overall Study COMPLETED	21	19
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Momba Mobile Application-based Community

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Access to MOMBA Web-based Application n=23 Participants 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. MOMBA web-based application: Web-based, interactive, social network application.	Smartphone Only n=24 Participants 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.	Total n=47 Participants Total of all reporting groups
Age, Customized Age category · 18-25	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Age, Customized Age category · 26+	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race / Ethnicity · White, Non-Hispanic	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Race / Ethnicity · Black or African American, Non-Hispanic	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized Race / Ethnicity · White, Hispanic	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Race / Ethnicity · Black or African American, Hispanic	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	24 participants n=7 Participants	47 participants n=5 Participants
PHQ-9	7.74 units on a scale STANDARD_DEVIATION 5.34 • n=5 Participants	11.25 units on a scale STANDARD_DEVIATION 6.21 • n=7 Participants	9.53 units on a scale STANDARD_DEVIATION 6.0 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Access to MOMBA Web-based Application n=23 Participants 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. MOMBA web-based application: Web-based, interactive, social network application.	Smartphone Only n=24 Participants 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.
Phone Retention Received 1 phone	9 Participants	15 Participants
Phone Retention Received a replacement phone	14 Participants	9 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Access to MOMBA Web-based Application n=23 Participants 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. MOMBA web-based application: Web-based, interactive, social network application.	Smartphone Only n=24 Participants 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.
Test the Proper Operating and Functioning of the MOMBA Application Number of participants trained to use phone	23 Participants	24 Participants
Test the Proper Operating and Functioning of the MOMBA Application Number of participants who did not receive training	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Access to MOMBA Web-based Application n=23 Participants 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. MOMBA web-based application: Web-based, interactive, social network application.	Smartphone Only n=24 Participants 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.
Acceptability and Performance of Structured Questionnaires Participants who completed a 12 month follow-up interview	20 Participants	19 Participants
Acceptability and Performance of Structured Questionnaires Participants who did not completed a 12 month follow-up interview	3 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Access to MOMBA Web-based Application n=20 Participants 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. MOMBA web-based application: Web-based, interactive, social network application.	Smartphone Only n=20 Participants 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.
Patient Health	5.6 score on a scale Standard Deviation 4.75	5.68 score on a scale Standard Deviation 6.37

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Access to MOMBA Web-based Application n=20 Participants 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. MOMBA web-based application: Web-based, interactive, social network application.	Smartphone Only n=20 Participants 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.
Confident Network Score	2.35 score on a scale Standard Deviation 1.39	1.5 score on a scale Standard Deviation 1.1

Adverse Events

Access to MOMBA Web-based Application

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Smartphone Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Megan Smith Associate Professor

Yale University

Phone: 203 764 8655

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place