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

Sponsor

University of California, San Diego (Other)

Overall Status

Completed

CT.gov ID

NCT01837147

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Behavioral: Technology-Based Physical Activity Promotion Behavioral: Pedometer Intervention	N/A

Study Design

Study Type:

Interventional

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 :

Apr 1, 2013

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in objectively-measured physical activity [Baseline to 16 weeks]
Assessed using ActiGraph.

Secondary Outcome Measures

Self-reported physical activity [Baseline to 16 weeks]
Assessed using questionnaires.
Body weight (kg) [Baseline to 16 weeks]
Measured in clinic.
Uptake of technology-based intervention components [During 16-week intervention]
To be assessed via data downloaded from the website used in this study.
Quality of life [Baseline to 16 weeks]
To be assessed via self-report questionnaire.