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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01837147
• Other study ID #: 1R03CA168450-01
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: October 2014

Study information

• Verified date: February 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Moores UCSD Cancer Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in objectively-measured physical activity	Assessed using ActiGraph.	Baseline to 16 weeks
Secondary	Self-reported physical activity	Assessed using questionnaires.	Baseline to 16 weeks
Secondary	Body weight (kg)	Measured in clinic.	Baseline to 16 weeks
Secondary	Uptake of technology-based intervention components	To be assessed via data downloaded from the website used in this study.	During 16-week intervention
Secondary	Quality of life	To be assessed via self-report questionnaire.	Baseline to 16 weeks