Trial Outcomes & Findings for Postnatal mHealth Intervention Development (NCT NCT04636398)
NCT ID: NCT04636398
Last Updated: 2024-06-04
Results Overview
Proportion of participants reporting to be "satisfied" or "very satisfied" with their overall intervention experience, assessed through a five-point Likert scale at six weeks.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
6 weeks
Results posted on
2024-06-04
Participant Flow
Participant milestones
| Measure |
MESSAGE mHealth Group Intervention
Participants in the one arm will be exposed to the mHealth group intervention. As this is a pilot developmental study, the participants will be exposed to various strategies for information delivery (live presentation at a scheduled time versus voice recording accessible at any time), discussion facilitation (heavily managed with request to speak vs. natural discussion participation), and text communication management (moderator-facilitated vs. group-led).
MESSAGE - mHealth intervention: A group-based moderated six-week intervention with didactic, discussion, and text communication components.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Postnatal mHealth Intervention Development
Baseline characteristics by cohort
| Measure |
MESSAGE mHealth Group Intervention
n=29 Participants
Participants in the one arm will be exposed to the mHealth group intervention. As this is a pilot developmental study, the participants will be exposed to various strategies for information delivery (live presentation at a scheduled time versus voice recording accessible at any time), discussion facilitation (heavily managed with request to speak vs. natural discussion participation), and text communication management (moderator-facilitated vs. group-led).
MESSAGE - mHealth intervention: A group-based moderated six-week intervention with didactic, discussion, and text communication components.
|
|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
25 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
29 participants
n=5 Participants
|
|
Personal smartphone
|
17 participants
n=5 Participants
|
|
Educational attainment
Illiterate
|
3 Participants
n=5 Participants
|
|
Educational attainment
Primary
|
2 Participants
n=5 Participants
|
|
Educational attainment
Higher primary
|
4 Participants
n=5 Participants
|
|
Educational attainment
Secondary
|
3 Participants
n=5 Participants
|
|
Educational attainment
Senior secondary
|
11 Participants
n=5 Participants
|
|
Educational attainment
Graduation
|
3 Participants
n=5 Participants
|
|
Educational attainment
Post-Graduation
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: We were unable to recruit an additional person to reach our target sample size of 30 within the time frame and criteria required for the group-oriented intervention.
Proportion of participants reporting to be "satisfied" or "very satisfied" with their overall intervention experience, assessed through a five-point Likert scale at six weeks.
Outcome measures
| Measure |
MESSAGE mHealth Group Intervention
n=29 Participants
Participants in the one arm will be exposed to the mHealth group intervention. As this is a pilot developmental study, the participants will be exposed to various strategies for information delivery (live presentation at a scheduled time versus voice recording accessible at any time), discussion facilitation (heavily managed with request to speak vs. natural discussion participation), and text communication management (moderator-facilitated vs. group-led).
MESSAGE - mHealth intervention: A group-based moderated six-week intervention with didactic, discussion, and text communication components.
|
|---|---|
|
Satisfied or Very Satisfied About Their Overall Intervention Experience
|
29 Participants
|
Adverse Events
MESSAGE mHealth Group Intervention
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place