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Using Technology to Improve Physical Activity Levels Among Postmenopausal Women (The Active & Aware Study)

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: NCT01837147
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Diego

Tracking Information
First Submitted Date  ICMJE April 6, 2013
First Posted Date  ICMJE April 23, 2013
Last Update Posted Date February 7, 2020
Actual Study Start Date  ICMJE April 2013
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
Change in objectively-measured physical activity [ Time Frame: Baseline to 16 weeks ]
Assessed using ActiGraph.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
  • Self-reported physical activity [ Time Frame: Baseline to 16 weeks ]
    Assessed using questionnaires.
  • Body weight (kg) [ Time Frame: Baseline to 16 weeks ]
    Measured in clinic.
  • Uptake of technology-based intervention components [ Time Frame: During 16-week intervention ]
    To be assessed via data downloaded from the website used in this study.
  • Quality of life [ Time Frame: Baseline to 16 weeks ]
    To be assessed via self-report questionnaire.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Technology to Improve Physical Activity Levels Among Postmenopausal Women (The Active & Aware Study)
Official Title  ICMJE Using Technology to Promote Activity in Women at Elevated Breast Cancer Risk
Brief Summary Women who are overweight or do not exercise are at higher risk for breast cancer after menopause. This study will test a new electronic device that measures the body's movement and works alongside a website to help women increase their physical activity level. If effective, this system could be tested in larger studies aiming to reduce breast cancer risk by reducing or preventing obesity.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Behavioral: Technology-Based Physical Activity Promotion
    Participants assigned to this group will use a web-integrated physical activity monitor, and accompanying website, to improve their physical activity levels.
  • Behavioral: Pedometer Intervention
    Participants assigned to this group will receive a pedometer and be trained in its use.
Study Arms  ICMJE
  • Experimental: Web-based Tracking Group
    Technology-Based Physical Activity Promotion
    Intervention: Behavioral: Technology-Based Physical Activity Promotion
  • Active Comparator: Pedometer Group
    Participants assigned to this group will receive a pedometer.
    Intervention: Behavioral: Pedometer Intervention
Publications *

*   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: February 5, 2020)
51
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2013)
50
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female
  • Postmenopausal
  • BMI >= 25.0 kg/m2
  • Physically inactive
  • Internet user with regular access to high-speed internet
  • Willing and able to complete study requirements

Exclusion Criteria:

  • History of invasive breast cancer
  • Medical contraindication to exercise
  • Medical problem or other issue that would interfere with intervention
  • Current participation in another physical activity study
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 80 Years   (Adult, Older 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 NCT01837147
Other Study ID Numbers  ICMJE 1R03CA168450-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lisa A Cadmus-Bertram, PhD University of California, San Diego
PRS Account University of California, San Diego
Verification Date February 2020

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