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Women's Health Initiative Strong and Healthy Study (WHISH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02425345
Recruitment Status : Active, not recruiting
First Posted : April 24, 2015
Last Update Posted : October 30, 2018
Sponsor:
Collaborators:
University of California, San Diego
Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

April 16, 2015
April 24, 2015
October 30, 2018
April 2015
January 2020   (Final data collection date for primary outcome measure)
  • Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality [ Time Frame: 4 years ]
    Adjudicated events
  • Non-Cardiovascular Disease Mortality [ Time Frame: 4 years ]
    Safety; adjudicated event
  • Hip Fracture [ Time Frame: 4 years ]
    Safety; adjudicated event
  • Clinical Fracture [ Time Frame: 4 years ]
    Safety
  • Falls [ Time Frame: 4 years ]
    Safety; self-report
  • Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality [ Time Frame: 4 years ]
  • Clinical Fracture [ Time Frame: 4 years ]
  • Falls [ Time Frame: 4 years ]
  • Non-Cardiovascular Disease Mortality [ Time Frame: 4 years ]
Complete list of historical versions of study NCT02425345 on ClinicalTrials.gov Archive Site
  • Venous Thromboembolic Event [ Time Frame: 4 years ]
    Adjudicated event
  • Peripheral Artery Disease [ Time Frame: 4 years ]
    Adjudicated event
  • Physical Function (Physical Function Score from self-report) [ Time Frame: 4 years ]
    Rand-36 Physical Function Scale. Score 0-100; a higher score indicates a more favorable health state in regards to physical functioning.
  • Mobility (Physical Function Score from self-report) [ Time Frame: 4 years ]
    Self-report of ability to climb one flight of stairs or ability to walk one block. Scored 1, 2 or 3 with 1=limited a lot, 2=limited a little, 3=not limited at all. Either stairs or walk with score of 2 or 3 is defined as being able to be mobile.
  • Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention) [ Time Frame: 4 years ]
    Safety; adjudicated events
  • Venous Thromboembolic Event [ Time Frame: 4 years ]
  • Peripheral Artery Disease [ Time Frame: 4 years ]
  • Physical Function (Rand-36 Physical Function Scale) [ Time Frame: 4 years ]
    Rand-36 Physical Function Scale
  • Mobility (Rand-36 Physical Function Scale) [ Time Frame: 4 years ]
  • Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention) [ Time Frame: 4 years ]
Not Provided
Not Provided
 
Women's Health Initiative Strong and Healthy Study
Women's Health Initiative Strong and Healthy Study
The WHISH trial applies state-of-the science behavioral principles and currently available technologies to deliver a physical activity intervention without face-to-face contact to ~25,000 older U.S. women expected to consent. It includes the National Institute of Aging (NIA) Go4Life® Exercise & Physical Activity materials 3 and WHISH developed targeted materials based on Go4Life® to provide inspirational tips and recommendations about how to achieve nationally recommended levels of PA and overcome barriers to exercise, with a means for self-monitoring and setting personal goals. The intervention builds upon evidence-based behavioral science principles and intervention components that have proven to be effective in increasing PA in older women, with innovative adaptive approaches to tailoring the delivery to meet individual (personal) needs.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
  • Myocardial Infarction
  • Stroke
  • Cardiovascular Mortality
  • Hip Fractures
  • Falls
  • Mortality
  • Venous Thromboembolic Event
  • Peripheral Artery Disease
Behavioral: Physical Activity
The PA intervention will consist of a multimodal activity program of aerobics, balance, strength, flexibility. The intervention will involve encouraging participants to increase all forms of PA throughout the day and to decrease sedentary time, such as sitting. This may include activities such as leisure sports, gardening, use of stairs instead of escalators, leisurely walks with friends, and less use of remote control devices.The intervention is conducted primarily by mail with website support and resources available.
  • Experimental: Physical Activity Intervention
    The Physical Activity Intervention Group will receive guidance on being physically active, including aerobics, flexibility, balance, strength, and decreased sedentary time. The primary resource is the National Institute of Aging Go4Life exercise and physical activity materials. The materials are based on the United States national guidelines for physical activity for older adults
    Intervention: Behavioral: Physical Activity
  • No Intervention: Usual Activity Control
    Usual activity
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
49376
52000
January 2020
January 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Currently enrolled in the Women's Health Initiative (WHI) Extension Study
  • Known to be alive
  • Cardiovascular outcomes will be available (enrolled in the WHI Medical Records Cohort or linked to Medicare Data)

Exclusion Criteria:

  • Inability to walk
  • Dementia
  • Residing in a nursing home
Sexes Eligible for Study: Female
Child, Adult, Older Adult
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT02425345
NHLBI 1 U01 HL122273-01A1
1U01HL122280-01A1 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
  • University of California, San Diego
  • Stanford University
  • National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Charles L Kooperberg, PhD Fred Hutchinson Cancer Research Center
Principal Investigator: Andrea Z LaCroix, PhD University of California, San Diego
Principal Investigator: Marcia L Stefanick, PhD Stanford University
Fred Hutchinson Cancer Research Center
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP