Women's Health Initiative Strong and Healthy Study

Not Applicable

Completed

• Conditions: Cardiovascular Mortality; Peripheral Artery Disease; Depressive Symptoms; Mortality; Stroke; Clinical (Non-hip) Fractures; Myocardial Infarction; Hip Fractures; Coronary Revascularization; Falls
• Interventions: Behavioral: Physical Activity

• Registration Number: NCT02425345
• Lead Sponsor: Fred Hutchinson Cancer 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-02
• Study First Submitted: 2015-04-16
• Study First Submitted QC: 2015-04-23
• Study First Posted: 2015-04-24
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49331

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical Activity Intervention	Physical Activity	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Venous Thromboembolic Event	9 years	Adjudicated event
Mobility and Independence (Physical Function Score from self-report)	9 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.
Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention)	9 years	Safety; adjudicated events
Physical Function (Physical Function Score from self-report)	9 years	Rand-36 Physical Function Scale. Score 0-100; a higher score indicates a more favorable health state in regards to physical functioning.
Depressive Symptoms	4 years	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.
Peripheral Artery Disease	9 years	Adjudicated event
Short Physical Performance Battery (SPPB)	4 years	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.
Sleep Disturbance	4 years	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.