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OpenTrials
Completed

NCT Number: NCT01837147

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

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.

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Key information

Conditions

Breast Cancer Behavior Body Weight Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Sedentary Behavior Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Moores UCSD Cancer Center

La Jolla, California, 92093, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Technology-Based Physical Activity Promotion

Behavioral

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

Pedometer Intervention

Behavioral

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

Primary outcomes

  1. Change in objectively-measured physical activity

    Time frame: Baseline to 16 weeks

    Assessed using ActiGraph.

Secondary outcomes

  1. Self-reported physical activity

    Time frame: Baseline to 16 weeks

    Assessed using questionnaires.

  2. Body weight (kg)

    Time frame: Baseline to 16 weeks

    Measured in clinic.

  3. 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.

  4. Quality of life

    Time frame: Baseline to 16 weeks

    To be assessed via self-report questionnaire.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 23, 2013
Registry last updated
Feb 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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