Trial Outcomes & Findings for The MOTHER (Mobile Technologies to Help Enhancing Regular Physical Activity) Trial for Pregnant Women (NCT NCT01461707)

NCT ID: NCT01461707

Last Updated: 2017-11-30

Results Overview

Change in weekly mean steps per day

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

12 weeks

Results posted on

2017-11-30

Participant Flow

Participant milestones

Participant milestones
Measure	Mobile App Plus Activity Monitor Group Participants in the group will receive a study mobile phone application and an activity monitor Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention.	Activity Monitor Group Participants in the group will receive an activity monitor
Overall Study STARTED	15	15
Overall Study COMPLETED	14	15
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Mobile App Plus Activity Monitor Group Participants in the group will receive a study mobile phone application and an activity monitor Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention.	Activity Monitor Group Participants in the group will receive an activity monitor
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

The MOTHER (Mobile Technologies to Help Enhancing Regular Physical Activity) Trial for Pregnant Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mobile App Plus Activity Monitor Group n=15 Participants Participants in the group will receive a study mobile phone application and an activity monitor Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention.	Activity Monitor Group n=15 Participants Participants in the group will receive an activity monitor	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	32.9 years STANDARD_DEVIATION 2.5 • n=5 Participants	34.5 years STANDARD_DEVIATION 2.5 • n=7 Participants	33.7 years STANDARD_DEVIATION 2.6 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	30 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 · Asian	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic/Latina	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Change in weekly mean steps per day

Outcome measures

Outcome measures
Measure	Mobile App Plus Activity Monitor Group n=14 Participants Participants in the group will receive a study mobile phone application and an activity monitor Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention.	Activity Monitor Group n=15 Participants Participants in the group will receive an activity monitor
Physical Activity Monitor Measured Steps Baseline to week 5-8	1092.1 step Standard Deviation 1925.3	804.3 step Standard Deviation 1752.9
Physical Activity Monitor Measured Steps Baseline to week 9-12	1096.2 step Standard Deviation 1898.1	258.7 step Standard Deviation 1603.7
Physical Activity Monitor Measured Steps Baseline to week 1-4	1166.6 step Standard Deviation 1709.4	1062.6 step Standard Deviation 2325.5

SECONDARY outcome

Timeframe: 12 weeks

Change in mean energy expenditure

Outcome measures

Outcome measures
Measure	Mobile App Plus Activity Monitor Group n=14 Participants Participants in the group will receive a study mobile phone application and an activity monitor Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention.	Activity Monitor Group n=15 Participants Participants in the group will receive an activity monitor
7-Day Physical Activity Recall	69 kcal/day Standard Deviation 223.1	204.3 kcal/day Standard Deviation 314.7

Adverse Events

Mobile App Plus Activity Monitor Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Activity Monitor Group

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

JiWon Choi

University of California, San Francisco

Phone: 415-514-2534

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place