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

NCT ID: NCT01837147

Last Updated: 2020-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Web-based Tracking Group

Technology-Based Physical Activity Promotion

Group Type EXPERIMENTAL

Technology-Based Physical Activity Promotion

Intervention Type BEHAVIORAL

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

Pedometer Group

Participants assigned to this group will receive a pedometer.

Group Type ACTIVE_COMPARATOR

Pedometer Intervention

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Pedometer Intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lisa A Cadmus-Bertram, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Moores UCSD Cancer Center

La Jolla, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 26586418 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26071863 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R03CA168450-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Improving Cognition After Cancer
NCT04049695 ACTIVE_NOT_RECRUITING NA
Moving Forward Together 4
NCT05409664 ACTIVE_NOT_RECRUITING NA