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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

Tracking Information
First Submitted Date  ICMJE October 26, 2011
First Posted Date  ICMJE October 28, 2011
Results First Submitted Date  ICMJE March 24, 2017
Results First Posted Date  ICMJE May 5, 2017
Last Update Posted Date November 30, 2017
Study Start Date  ICMJE October 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2017)
Physical Activity Monitor Measured Steps [ Time Frame: 12 weeks ]
Change in weekly mean steps per day
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2011)
Physical Activity Monitor Measured Steps [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2017)
7-Day Physical Activity Recall [ Time Frame: 12 weeks ]
Change in mean energy expenditure
Original Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2011)
7-Day Physical Activity Recall [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The MOTHER (Mobile Technologies to Help Enhancing Regular Physical Activity) Trial for Pregnant Women
Official Title  ICMJE A Pilot Study of a Mobile Phone-Based Physical Activity Program in Pregnant Women
Brief Summary Obesity among women of childbearing age and excessive weight gain during pregnancy are prevalent and steadily increasing health care issues. Regular physical activity is recommended to maintain healthy weight gain for pregnant women, however, a majority of pregnant women are sedentary. The investigators proposed to conduct a pilot study to estimate the potential efficacy of a mobile phone based physical activity intervention in 30 physically inactive pregnant women.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Physical Activity
Intervention  ICMJE
  • Behavioral: Mobile phone-based physical activity
    Participants will receive the mobile phone-based physical activity program using the trial app.
  • Behavioral: Activity monitor
    Participants will receive an activity monitor
Study Arms  ICMJE
  • Experimental: Mobile app plus activity monitor group
    Participants in the group will receive the mobile phone-based physical activity program and an activity monitor
    Interventions:
    • Behavioral: Mobile phone-based physical activity
    • Behavioral: Activity monitor
  • Active Comparator: Activity monitor group
    Participants in the group will receive an activity monitor
    Intervention: Behavioral: Activity monitor
Publications * Choi J, Lee JH, Vittinghoff E, Fukuoka Y. mHealth Physical Activity Intervention: A Randomized Pilot Study in Physically Inactive Pregnant Women. Matern Child Health J. 2016 May;20(5):1091-101. doi: 10.1007/s10995-015-1895-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 27, 2011)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • pregnant, gestational week (10-20 weeks)
  • pre-pregnancy BMI ≥ 18.5 kg•m2
  • physically inactive at work and during leisure time
  • intent to be physically active
  • access to a home telephone or a mobile phone
  • have a personal computer access
  • ability to communicate (speak and read) in English.

Exclusion Criteria:

  • known medical or obstetric complication that restricts physical activity
  • history of eating disorders
  • current participation in lifestyle modification programs
  • history of bariatric surgery.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01461707
Other Study ID Numbers  ICMJE 11-06992
3R01HL104147-02S1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: JiWon Choi, PhD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP