Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Technology-Based Physical Activity Promotion Behavioral: Pedometer Intervention Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Using Technology to Promote Activity in Women at Elevated Breast Cancer Risk
Actual Study Start Date : April 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Web-based Tracking Group
Technology-Based Physical Activity Promotion
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.

Active Comparator: Pedometer Group
Participants assigned to this group will receive a pedometer.
Behavioral: Pedometer Intervention
Participants assigned to this group will receive a pedometer and be trained in its use.




Primary Outcome Measures :
  1. Change in objectively-measured physical activity [ Time Frame: Baseline to 16 weeks ]
    Assessed using ActiGraph.


Secondary Outcome Measures :
  1. Self-reported physical activity [ Time Frame: Baseline to 16 weeks ]
    Assessed using questionnaires.

  2. Body weight (kg) [ Time Frame: Baseline to 16 weeks ]
    Measured in clinic.

  3. 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.

  4. Quality of life [ Time Frame: Baseline to 16 weeks ]
    To be assessed via self-report questionnaire.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837147


Locations
Layout table for location information
United States, California
Moores UCSD Cancer Center
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Investigators
Layout table for investigator information
Principal Investigator: Lisa A Cadmus-Bertram, PhD University of California, San Diego

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of California, San Diego
ClinicalTrials.gov Identifier: NCT01837147    
Other Study ID Numbers: 1R03CA168450-01 ( U.S. NIH Grant/Contract )
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Keywords provided by University of California, San Diego:
primary prevention
sedentary
overweight
obesity
breast cancer
post-menopausal
women
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases