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

February 5, 2020 updated by: University of California, San Diego

Using Technology to Promote Activity in Women at Elevated Breast Cancer Risk

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • Moores UCSD Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in objectively-measured physical activity
Time Frame: Baseline to 16 weeks
Assessed using ActiGraph.
Baseline to 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported physical activity
Time Frame: Baseline to 16 weeks
Assessed using questionnaires.
Baseline to 16 weeks
Body weight (kg)
Time Frame: Baseline to 16 weeks
Measured in clinic.
Baseline to 16 weeks
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.
During 16-week intervention
Quality of life
Time Frame: Baseline to 16 weeks
To be assessed via self-report questionnaire.
Baseline to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: Lisa A Cadmus-Bertram, PhD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

April 6, 2013

First Submitted That Met QC Criteria

April 17, 2013

First Posted (Estimate)

April 23, 2013

Study Record Updates

Last Update Posted (Actual)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R03CA168450-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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