Women's Health Initiative Strong and Healthy Study

Study Overview
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Brief Summary
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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.

Official Title
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Women's Health Initiative Strong and Healthy Study

Conditions
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Stroke, Myocardial Infarction, Cardiovascular Mortality, Hip Fractures, Falls, Mortality, Venous Thromboembolic Event, Peripheral Artery Disease, Physical Function, Coronary Revascularization, Mobility and Independence, Clinical (Non-hip) Fractures, Sleep, Depressive Symptoms

Intervention / Treatment
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* Behavioral: Physical Activity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 66 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Activity Intervention<br>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<br>* 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.<br>|
| No Intervention: Usual Activity Control<br>Usual activity | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality | Adjudicated events | 9 years | 
| Non-Cardiovascular Disease Mortality | Safety; adjudicated event | 9 years | 
| Hip Fracture | Safety; adjudicated event | 9 years | 
| Clinical (non-hip) Fracture | Safety | 9 years | 
| Falls | Safety; self-report | 9 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous Thromboembolic Event | Adjudicated event | 9 years | 
| Peripheral Artery Disease | Adjudicated event | 9 years | 
| Physical Function (Physical Function Score from self-report) | Rand-36 Physical Function Scale. Score 0-100; a higher score indicates a more favorable health state in regards to physical functioning. | 9 years | 
| Mobility and Independence (Physical Function Score from self-report) | 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. | 9 years | 
| Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention) | Safety; adjudicated events | 9 years | 
| Short Physical Performance Battery (SPPB) | Short Performance Battery (SPPB). Scoring uses the Look AHEAD methods that were based on Health ABC (Simonsick EM, Newman AB, Nevitt MC, et al. Measuring higher level physical function in well-functioning older adults: expanding familiar approaches in the Health ABC Study. J Gerontol Med Sci. 2001;56A,M644-M649.) The SPPB score is sum of three ratios, the Standing Balance Ratio (SBRatio), the Chair Stand Ratio (CSRatio), and the Usual Walk Ratio (UWRatio). The results are in a continuous score ranging from 0 to 3. s (balance, gait speed, stair stand) are each scored 0 or 1 with the three scores summed for an SPPB score of 0 to 3 from lowest to highest physical function. Implemented in a subset. | 4 years | 
| 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. | 4 years | 
| 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. | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip Fractures, 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), Cardiovascular Mortality, Clinical (non-hip) Fractures, Sleep, Depressive Symptoms