Women's Health Initiative Strong and Healthy Study "WHISH"

Active, not recruiting

Phase 3 Results N/A

Trial Description

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 an algorithm-driven interactive voice response (IVR) system, built to complement the National Institute of Aging (NIA) Go4LifeĀ® Exercise & Physical Activity materials 3, which provides tailored advice on 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.

Conditions

Interventions

  • Physical Activity Other
    Intervention Desc: 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.An interactive voice response (IVR) coach will be available. The intervention is conducted primarily by mail and optionally by phone and the IVR.
    ARM 1: Kind: Experimental
    Label: Physical Activity Intervention
    Description: 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

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality 4 years No
Primary Clinical Fracture 4 years Yes
Primary Falls 4 years Yes
Primary Non-Cardiovascular Disease Mortality 4 years Yes
Secondary Venous Thromboembolic Event 4 years No
Secondary Peripheral Artery Disease 4 years No
Secondary Physical Function (Rand-36 Physical Function Scale) 4 years No
Secondary Mobility (Rand-36 Physical Function Scale) 4 years Yes
Secondary Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention) 4 years Yes

Sponsors