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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Technology-Based Physical Activity Promotion
* Behavioral: Pedometer Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-based Tracking Group<br>Technology-Based Physical Activity Promotion | Behavioral: Technology-Based Physical Activity Promotion<br>* Participants assigned to this group will use a web-integrated physical activity monitor, and accompanying website, to improve their physical activity levels.<br>|
| Active Comparator: Pedometer Group<br>Participants assigned to this group will receive a pedometer. | Behavioral: Pedometer Intervention<br>* Participants assigned to this group will receive a pedometer and be trained in its use.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, primary prevention, sedentary, overweight, obesity, post-menopausal, women