Trial Outcomes & Findings for Pilot Testing a Mobile App to Designed to Increase Physical Activity Among Pregnant and Postpartum Women (NCT NCT04480931)
NCT ID: NCT04480931
Last Updated: 2026-08-24
Results Overview
% of women who complete the study protocol
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
12 weeks postpartum
Results posted on
2026-08-24
Participant Flow
No women dropped out between enrollment and group assignment.
Participant milestones
| Measure |
mHealth Intervention Group
This group will be provided with the mobile health app (including introductory videos on how to use its features).
mHealth Intervention Group: Access to the mobile health application with exercise plans and education
|
Control Group
This group will receive an educational brochure about physical activity during pregnancy.
Educational Brochure: An evidence-based educational brochure with general information about the benefits of physical activity during pregnancy
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
mHealth Intervention Group
This group will be provided with the mobile health app (including introductory videos on how to use its features).
mHealth Intervention Group: Access to the mobile health application with exercise plans and education
|
Control Group
This group will receive an educational brochure about physical activity during pregnancy.
Educational Brochure: An evidence-based educational brochure with general information about the benefits of physical activity during pregnancy
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Two intervention participants and one control participant did not fully complete the study and therefore, were not included in the analyses.
Baseline characteristics by cohort
| Measure |
mHealth Intervention Group
n=19 Participants
This group will be provided with the mobile health app (including introductory videos on how to use its features).
mHealth Intervention Group: Access to the mobile health application with exercise plans and education
|
Control Group
n=19 Participants
This group will receive an educational brochure about physical activity during pregnancy.
Educational Brochure: An evidence-based educational brochure with general information about the benefits of physical activity during pregnancy
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.69 years
STANDARD_DEVIATION 4.22 • n=1541 Participants
|
30.28 years
STANDARD_DEVIATION 4.71 • n=1121 Participants
|
30.94 years
STANDARD_DEVIATION 4.48 • n=2662 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=1541 Participants
|
19 Participants
n=1121 Participants
|
38 Participants
n=2662 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=1541 Participants
|
19 Participants
n=1121 Participants
|
38 Participants
n=2662 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=1541 Participants • Two intervention participants and one control participant did not fully complete the study and therefore, were not included in the analyses.
|
19 participants
n=1121 Participants • Two intervention participants and one control participant did not fully complete the study and therefore, were not included in the analyses.
|
38 participants
n=2662 Participants • Two intervention participants and one control participant did not fully complete the study and therefore, were not included in the analyses.
|
|
Physical Activity Level
|
12.5 % of time over a week
STANDARD_DEVIATION 5.9 • n=1541 Participants
|
13.5 % of time over a week
STANDARD_DEVIATION 5.1 • n=1121 Participants
|
13.0 % of time over a week
STANDARD_DEVIATION 5.5 • n=2662 Participants
|
PRIMARY outcome
Timeframe: 12 weeks postpartumPopulation: Pregnant women who joined the study at 23-25 weeks. Women were 12 weeks postpartum when this outcome was collected.
% of women who complete the study protocol
Outcome measures
| Measure |
mHealth Intervention Group
n=19 Participants
Received access to the mHealth Intervention
|
Control Group
n=19 Participants
Received only an educational brochure
|
|---|---|---|
|
Protocol Retention
|
17 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: Pregnancy (35-37 weeks gestation)Population: All women were 35-37 weeks pregnant and still in the study with a healthy pregnancy.
Assess the potential efficacy of the intervention by examining physical activity levels through objective actigraph data
Outcome measures
| Measure |
mHealth Intervention Group
n=17 Participants
Received access to the mHealth Intervention
|
Control Group
n=18 Participants
Received only an educational brochure
|
|---|---|---|
|
Physical Activity Levels
|
13.8 % of time over one week
Standard Deviation 5.7
|
12.3 % of time over one week
Standard Deviation 4.8
|
PRIMARY outcome
Timeframe: Postpartum (12 weeks)Population: All women who still enrolled in the study 12 weeks after giving birth.
Assess the potential efficacy of the intervention by examining physical activity levels through objective actigraph data
Outcome measures
| Measure |
mHealth Intervention Group
n=17 Participants
Received access to the mHealth Intervention
|
Control Group
n=19 Participants
Received only an educational brochure
|
|---|---|---|
|
Physical Activity Levels
|
14.6 % of time over one week
Standard Error 5.5
|
13.8 % of time over one week
Standard Error 5.0
|
Adverse Events
mHealth Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
mHealth Intervention Group
n=17 participants at risk
This group will be provided with the mobile health app (including introductory videos on how to use its features).
mHealth Intervention Group: Access to the mobile health application with exercise plans and education
|
Control Group
n=18 participants at risk
This group will receive an educational brochure about physical activity during pregnancy.
Educational Brochure: An evidence-based educational brochure with general information about the benefits of physical activity during pregnancy
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
infant loss
|
0.00%
0/17 • From 23-25 weeks up pregnancy through 12 weeks postpartum
|
5.6%
1/18 • Number of events 1 • From 23-25 weeks up pregnancy through 12 weeks postpartum
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place