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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
49,331
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.
Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality
WHI centrally adjudicated events and CMS FFS-identified events. CVD defined as (first event since enrollment in WHISH of) MI, stroke, cardiovascular (CV) death.
Time frame: median 8.7 years
Physical Function (Physical Function Score From Self-report, RAND-36)
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.
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.
Non-Cardiovascular Disease Mortality
Safety. WHI centrally adjudicated events and CMS FFS-identified events.
Time frame: median 8.7 years
Hip Fracture
Safety. WHI centrally adjudicated events and CMS FFS-identified events.
Time frame: median 8.7 years
Falls / Year
Safety; self-report
Time frame: median 8.7 years
Clinical (Non-hip) Fracture
Safety. Self-report
Time frame: median 8.7 years
Peripheral Artery Disease
WHI centrally adjudicated events and CMS FFS-identified events.
Time frame: median 8.7 years
Venous Thromboembolic Event
WHI centrally adjudicated events and CMS FFS-identified events.
Time frame: median 8.7 years
Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention)
Safety; adjudicated events
Time frame: median 8.7 years
Mobility Loss
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. Mobility Loss: Defined as Yes if a participant self-reports being limited a lot (score =1) in both climbing one flight of stairs and walking one block. Mobility loss defined as Yes is reported as an Event.
Time frame: median 8.7 years
Short Physical Performance Battery (SPPB)
SPPB collected one time during second funding period for WHISH, within the 4-year trial period, as part of the Women's Health Initiative in-home visit, the Long Life Study 2 during 2022-2024. The Established Populations for the Epidemiologic Studies of the Eldery (EPESE) Short Physical Performance Battery (SPPB) ranges from 0 to 12, with higher scores indicating better physical performance.
Time frame: One time per participant analyzed during study year 7, 8, or 9.
Sleep Disturbance
Self-report of sleep patterns such as falling asleep, waking during the night, quality of night's sleep. Score scale: 0 - 20; a higher score indicates greater sleep disturbance. Levine DW, Kaplan RM, Kripke DF, Naughton MJ, Shumaker SA. Factor structure and measurement invariance of the Women's Health Initiative Insomnia Rating Scale. Psycho Assess. 2003 Jun; 15(2):123-36. Data not collected prior to 1/6/2021. The single value for this Outcome is based on the average of all collected measurements.
Time frame: 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
Shortened version of the Center for Epidemiological Studies Depression Scale (CES- D). Score (probability) for depression. Score scale: 0 - 1; a higher score indicates a greater likelihood of depression. Burman M, Wells K, Leake B, Landsverk J. Development of a brief screening instrument for detecting depressive disorders. Medical care 1988; 26: 8, 775-789. Data not collected prior to 1/6/2021. The single value for this Outcome is based on the average of all collected measurements.
Time frame: Annually during study years 6, 7, 8, 9. The single value for this Outcome is based on the average of all collected measurements.
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