Women's Health Initiative Strong and Healthy Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 49,331
- Primary Endpoint
- Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 66 Years to 99 Years (Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- •Residing in a nursing home
Arms & Interventions
Usual Activity Control
Usual activity
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: Physical Activity (Behavioral)
Outcomes
Primary Outcomes
Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality
Time Frame: 9 years
Adjudicated events
Non-Cardiovascular Disease Mortality
Time Frame: 9 years
Safety; adjudicated event
Hip Fracture
Time Frame: 9 years
Safety; adjudicated event
Clinical (non-hip) Fracture
Time Frame: 9 years
Safety
Falls
Time Frame: 9 years
Safety; self-report
Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality
Time Frame: median 8.7 years
WHI centrally adjudicated events and CMS FFS-identified events. CVD defined as (first event since enrollment in WHISH of) MI, stroke, cardiovascular (CV) death.
Physical Function (Physical Function Score From Self-report, RAND-36)
Time Frame: Annually each year of the 9 years of the trial. The single value for this Outcome is based on the average of all collected measurements.
Rand-36 Physical Function Scale. Score 0-100; a higher score indicates a more favorable health state in regards to physical functioning. The single value for this Outcome is based on the average of all collected measurements.
Non-Cardiovascular Disease Mortality
Time Frame: median 8.7 years
Safety. WHI centrally adjudicated events and CMS FFS-identified events.
Hip Fracture
Time Frame: median 8.7 years
Safety. WHI centrally adjudicated events and CMS FFS-identified events.
Falls / Year
Time Frame: median 8.7 years
Safety; self-report
Clinical (Non-hip) Fracture
Time Frame: median 8.7 years
Safety. Self-report
Secondary Outcomes
- Venous Thromboembolic Event(9 years)
- Peripheral Artery Disease(9 years)
- Mobility and Independence (Physical Function Score from self-report)(9 years)
- Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention)(9 years)
- Short Physical Performance Battery (SPPB)(4 years)
- Sleep Disturbance(4 years)
- Depressive Symptoms(4 years)
- Peripheral Artery Disease(median 8.7 years)
- Venous Thromboembolic Event(median 8.7 years)
- Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention)(median 8.7 years)
- Mobility Loss(median 8.7 years)
- Short Physical Performance Battery (SPPB)(One time per participant analyzed during study year 7, 8, or 9.)
- Sleep Disturbance(Annually during study years 6, 7, 8, and 9. The single value for this Outcome is based on the average of all collected measurements.)
- Depressive Symptoms(Annually during study years 6, 7, 8, 9. The single value for this Outcome is based on the average of all collected measurements.)