NCT01837147

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 23, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

1.5 years

First QC Date

April 6, 2013

Last Update Submit

February 5, 2020

Conditions

Breast Cancer

Keywords

primary preventionsedentaryoverweightobesitybreast cancerpost-menopausalwomen

Outcome Measures

Primary Outcomes (1)

  • Change in objectively-measured physical activity

    Assessed using ActiGraph.

    Baseline to 16 weeks

Secondary Outcomes (4)

  • Self-reported physical activity

    Baseline to 16 weeks

  • Body weight (kg)

    Baseline to 16 weeks

  • Uptake of technology-based intervention components

    During 16-week intervention

  • Quality of life

    Baseline to 16 weeks

Study Arms (2)

Web-based Tracking Group

EXPERIMENTAL

Technology-Based Physical Activity Promotion

Behavioral: Technology-Based Physical Activity Promotion

Pedometer Group

ACTIVE COMPARATOR

Participants assigned to this group will receive a pedometer.

Behavioral: Pedometer Intervention

Interventions

Technology-Based Physical Activity PromotionBEHAVIORAL

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

Web-based Tracking Group
Pedometer InterventionBEHAVIORAL

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

Pedometer Group

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moores UCSD Cancer Center

La Jolla, California, 92093, United States

Location

Related Publications (2)

  • 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.

    PMID: 26586418DERIVED

  • 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.

    PMID: 26071863DERIVED

MeSH Terms

Conditions

Breast NeoplasmsSedentary BehaviorOverweightObesity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lisa A Cadmus-Bertram, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2013

First Posted

April 23, 2013

Study Start

April 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

February 7, 2020

Record last verified: 2020-02

Locations

US(1)