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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Technology-Based Physical Activity Promotion

Pedometer Intervention

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring primary prevention, sedentary, overweight, obesity, breast cancer, post-menopausal, women

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Moores UCSD Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Web-based Tracking Group

Pedometer Group

Arm Description

Technology-Based Physical Activity Promotion

Participants assigned to this group will receive a pedometer.

Outcomes

Primary Outcome Measures

Change in objectively-measured physical activity

Assessed using ActiGraph.

Secondary Outcome Measures

Self-reported physical activity

Assessed using questionnaires.

Body weight (kg)

Measured in clinic.

Uptake of technology-based intervention components

To be assessed via data downloaded from the website used in this study.

Quality of life

To be assessed via self-report questionnaire.

Full Information

NCT ID

NCT01837147

First Posted

April 6, 2013

Last Updated

February 5, 2020

Sponsor

University of California, San Diego

1. Study Identification

Unique Protocol Identification Number

NCT01837147

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

April 2013 (Actual)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Diego

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

primary prevention, sedentary, overweight, obesity, breast cancer, post-menopausal, women

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Web-based Tracking Group

Arm Type

Experimental

Arm Description

Technology-Based Physical Activity Promotion

Arm Title

Pedometer Group

Arm Type

Active Comparator

Arm Description

Participants assigned to this group will receive a pedometer.

Intervention Type

Behavioral

Intervention Name(s)

Technology-Based Physical Activity Promotion

Intervention Description

Participants assigned to this group will use a web-integrated physical activity monitor, and accompanying website, to improve their physical activity levels.

Intervention Type

Behavioral

Intervention Name(s)

Pedometer Intervention

Intervention Description

Participants assigned to this group will receive a pedometer and be trained in its use.

Primary Outcome Measure Information:

Title

Change in objectively-measured physical activity

Description

Assessed using ActiGraph.

Time Frame

Baseline to 16 weeks

Secondary Outcome Measure Information:

Title

Self-reported physical activity

Description

Assessed using questionnaires.

Time Frame

Baseline to 16 weeks

Title

Body weight (kg)

Description

Measured in clinic.

Time Frame

Baseline to 16 weeks

Title

Uptake of technology-based intervention components

Description

To be assessed via data downloaded from the website used in this study.

Time Frame

During 16-week intervention

Title

Quality of life

Description

To be assessed via self-report questionnaire.

Time Frame

Baseline to 16 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lisa A Cadmus-Bertram, PhD

Organizational Affiliation

University of California, San Diego

Official's Role

Principal Investigator

Facility Information:

Facility Name

Moores UCSD Cancer Center

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26586418

Citation

Cadmus-Bertram L, Marcus BH, Patterson RE, Parker BA, Morey BL. Use of the Fitbit to Measure Adherence to a Physical Activity Intervention Among Overweight or Obese, Postmenopausal Women: Self-Monitoring Trajectory During 16 Weeks. JMIR Mhealth Uhealth. 2015 Nov 19;3(4):e96. doi: 10.2196/mhealth.4229.

Results Reference

derived

PubMed Identifier

26071863

Citation

Cadmus-Bertram LA, Marcus BH, Patterson RE, Parker BA, Morey BL. Randomized Trial of a Fitbit-Based Physical Activity Intervention for Women. Am J Prev Med. 2015 Sep;49(3):414-8. doi: 10.1016/j.amepre.2015.01.020. Epub 2015 Jun 10.

Results Reference

derived

Learn more about this trial

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

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