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

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01461707
First received: October 26, 2011
Last updated: March 24, 2017
Last verified: March 2017
Results First Received: March 24, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant;   Primary Purpose: Prevention
Condition: Physical Activity
Interventions: Behavioral: Mobile phone-based physical activity
Behavioral: Activity monitor

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Mobile App Plus Activity Monitor Group   Activity Monitor Group
STARTED   15   15 
COMPLETED   14   15 
NOT COMPLETED   1   0 
Withdrawal by Subject                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   Mobile App Plus Activity Monitor Group   Activity Monitor Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   15   30 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 32.9  (2.5)   34.5  (2.5)   33.7  (2.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      15 100.0%      15 100.0%      30 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race       
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 
[Units: Participants]
Count of Participants
     
United States   15   15   30 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Physical Activity Monitor Measured Steps   [ Time Frame: 12 weeks ]

2.  Secondary:   7-Day Physical Activity Recall   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: JiWon Choi
Organization: University of California, San Francisco
phone: 415-514-2534
e-mail: jiwon.choi@ucsf.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01461707     History of Changes
Other Study ID Numbers: 11-06992
3R01HL104147-02S1 ( US NIH Grant/Contract Award Number )
Study First Received: October 26, 2011
Results First Received: March 24, 2017
Last Updated: March 24, 2017