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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 : June 5, 2019
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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Stroke Cardiovascular Mortality Hip Fractures Falls Mortality Venous Thromboembolic Event Peripheral Artery Disease Physical Function Coronary Revascularization Mobility and Independence Clinical (Non-hip) Fractures Behavioral: Physical Activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49333 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Women's Health Initiative Strong and Healthy Study
Study Start Date : April 2, 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.

No Intervention: Usual Activity Control
Usual activity



Primary Outcome Measures :
  1. Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality [ Time Frame: 4 years ]
    Adjudicated events

  2. Non-Cardiovascular Disease Mortality [ Time Frame: 4 years ]
    Safety; adjudicated event

  3. Hip Fracture [ Time Frame: 4 years ]
    Safety; adjudicated event

  4. Clinical (non-hip) Fracture [ Time Frame: 4 years ]
    Safety

  5. Falls [ Time Frame: 4 years ]
    Safety; self-report


Secondary Outcome Measures :
  1. Venous Thromboembolic Event [ Time Frame: 4 years ]
    Adjudicated event

  2. Peripheral Artery Disease [ Time Frame: 4 years ]
    Adjudicated event

  3. 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.

  4. Mobility and Independence (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.

  5. Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention) [ Time Frame: 4 years ]
    Safety; adjudicated events



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02425345


Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
University of California, San Diego
Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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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

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Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT02425345     History of Changes
Other Study ID Numbers: NHLBI 1 U01 HL122273-01A1
1U01HL122280-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

Keywords provided by Fred Hutchinson Cancer Research Center:
Physical Activity
National Institute of Aging Go4Life
Postmenopausal Women
Balance
Strength
Exercise
Cardiovascular Disease
Stroke
Mortality
Myocardial Infarction
Falls
Venous Thromboembolic Event
Peripheral Artery Disease
Physical Function
Mobility and Independence
Coronary Artery Bypass Graft (CABG)
Percutaneous Coronary Intervention (PCI)
Hip Fractures
Cardiovascular Mortality
Clinical (non-hip) Fractures

Additional relevant MeSH terms:
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Fractures, Bone
Infarction
Myocardial Infarction
Hip Fractures
Peripheral Arterial Disease
Thromboembolism
Wounds and Injuries
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Femoral Fractures
Hip Injuries
Leg Injuries
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Peripheral Vascular Diseases
Embolism and Thrombosis