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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01837147

Enrollment

Registered

2013-04-23

Start date

2013-04-30

Completion date

2014-10-31

Last updated

2020-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

primary prevention, sedentary, overweight, obesity, breast cancer, post-menopausal, women

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.

Interventions

BEHAVIORALTechnology-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.

BEHAVIORALPedometer Intervention

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026