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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01461707
Recruitment Status : Completed
First Posted : October 28, 2011
Results First Posted : May 5, 2017
Last Update Posted : November 30, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Physical Activity
Interventions Behavioral: Mobile phone-based physical activity
Behavioral: Activity monitor
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mobile App Plus Activity Monitor Group Activity Monitor Group
Hide Arm/Group Description

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.

Participants in the group will receive an activity monitor
Period Title: Overall Study
Started 15 15
Completed 14 15
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Mobile App Plus Activity Monitor Group Activity Monitor Group Total
Hide Arm/Group Description

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.

Participants in the group will receive an activity monitor Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
15
 100.0%
30
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
32.9  (2.5) 34.5  (2.5) 33.7  (2.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
15
 100.0%
15
 100.0%
30
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 15 participants 15 participants 30 participants
Asian
5
  33.3%
7
  46.7%
12
  40.0%
Black
1
   6.7%
1
   6.7%
2
   6.7%
Hispanic/Latina
2
  13.3%
1
   6.7%
3
  10.0%
White
7
  46.7%
6
  40.0%
13
  43.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15
 100.0%
15
 100.0%
30
 100.0%
1.Primary Outcome
Title Physical Activity Monitor Measured Steps
Hide Description Change in weekly mean steps per day
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mobile App Plus Activity Monitor Group Activity Monitor Group
Hide Arm/Group Description:

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.

Participants in the group will receive an activity monitor
Overall Number of Participants Analyzed 14 15
Mean (Standard Deviation)
Unit of Measure: step
Baseline to week 1-4 1166.6  (1709.4) 1062.6  (2325.5)
Baseline to week 5-8 1092.1  (1925.3) 804.3  (1752.9)
Baseline to week 9-12 1096.2  (1898.1) 258.7  (1603.7)
2.Secondary Outcome
Title 7-Day Physical Activity Recall
Hide Description Change in mean energy expenditure
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mobile App Plus Activity Monitor Group Activity Monitor Group
Hide Arm/Group Description:

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.

Participants in the group will receive an activity monitor
Overall Number of Participants Analyzed 14 15
Mean (Standard Deviation)
Unit of Measure: kcal/day
69  (223.1) 204.3  (314.7)
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mobile App Plus Activity Monitor Group Activity Monitor Group
Hide Arm/Group Description

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.

Participants in the group will receive an activity monitor
All-Cause Mortality
Mobile App Plus Activity Monitor Group Activity Monitor Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Mobile App Plus Activity Monitor Group Activity Monitor Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mobile App Plus Activity Monitor Group Activity Monitor Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: JiWon Choi
Organization: University of California, San Francisco
Phone: 415-514-2534
EMail: jiwon.choi@ucsf.edu
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01461707    
Other Study ID Numbers: 11-06992
3R01HL104147-02S1 ( U.S. NIH Grant/Contract )
First Submitted: October 26, 2011
First Posted: October 28, 2011
Results First Submitted: March 24, 2017
Results First Posted: May 5, 2017
Last Update Posted: November 30, 2017