Women's Health Initiative Strong and Healthy Study (WHISH)

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 Overview

• Status: Completed
• Conditions: Myocardial Infarction; Stroke; Mortality; Sleep; Depressive Symptoms; Hip Fractures; Peripheral Artery Disease; Falls; Physical Function; Cardiovascular Mortality; Coronary Revascularization; Venous Thromboembolic Event; Mobility and Independence; Clinical (Non-hip) Fractures
• Intervention / Treatment: Behavioral: Physical Activity

• Study Type: Interventional
• Enrollment (Actual): 49331
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 66 years to 99 years (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: Physical Activity; 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.
No Intervention: Usual Activity Control; Usual activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	median 8.7 years
Hip Fracture	Safety. WHI centrally adjudicated events and CMS FFS-identified events.	median 8.7 years
Falls / Year	Safety; self-report	median 8.7 years
Clinical (Non-hip) Fracture	Safety. Self-report	median 8.7 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral Artery Disease	WHI centrally adjudicated events and CMS FFS-identified events.	median 8.7 years
Venous Thromboembolic Event	WHI centrally adjudicated events and CMS FFS-identified events.	median 8.7 years
Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention)	Safety; adjudicated events	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.	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.	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.	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.	Annually during study years 6, 7, 8, 9. The single value for this Outcome is based on the average of all collected measurements.

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: University of California, San Diego; National Heart, Lung, and Blood Institute (NHLBI); Stanford University
• Investigators: Principal Investigator: Charles L Kooperberg, PhD, Fred Hutchinson Cancer Center; Principal Investigator: Marcia L Stefanick, PhD, Stanford University; Principal Investigator: Andrea Z LaCroix, PhD, University of California, San Diego

Publications and helpful links

General Publications

• Stefanick ML, King AC, Mackey S, Tinker LF, Hlatky MA, LaMonte MJ, Bellettiere J, Larson JC, Anderson G, Kooperberg CL, LaCroix AZ. Women's Health Initiative Strong and Healthy Pragmatic Physical Activity Intervention Trial for Cardiovascular Disease Prevention: Design and Baseline Characteristics. J Gerontol A Biol Sci Med Sci. 2021 Mar 31;76(4):725-734. doi: 10.1093/gerona/glaa325.
• Stefanick ML, Kooperberg C, LaCroix AZ. Women's Health Initiative Strong and Healthy (WHISH): A pragmatic physical activity intervention trial for cardiovascular disease prevention. Contemp Clin Trials. 2022 Aug;119:106815. doi: 10.1016/j.cct.2022.106815. Epub 2022 Jun 9.
• Mendoza-Vasconez AS, King AC, Chandler G, Mackey S, Follis S, Stefanick ML. Engagement With Remote Delivery Channels in a Physical Activity Intervention for Senior Women in the US. Am J Health Promot. 2024 Jun;38(5):692-703. doi: 10.1177/08901171241229537. Epub 2024 Feb 12.

Helpful Links

• Women's Health Initiative Strong and Healthy Pragmatic Physical Activity Intervention Trial for Cardiovascular Disease Prevention: Design and Baseline Characteristics

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2015
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: April 16, 2015
• First Submitted That Met QC Criteria: April 23, 2015
• First Posted (Estimated): April 24, 2015

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise; Balance; Stroke; Cardiovascular Disease; Sleep; Physical Function; Peripheral Artery Disease; Mortality; Myocardial Infarction; Strength; Depressive Symptoms; Falls; Postmenopausal Women; Hip Fractures; Percutaneous Coronary Intervention (PCI); Cardiovascular Mortality; Coronary Artery Bypass Graft (CABG); National Institute of Aging Go4Life; Venous Thromboembolic Event; Mobility and Independence; Clinical (non-hip) Fractures
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Wounds and Injuries; Pathologic Processes; Heart Diseases; Behavioral Symptoms; Leg Injuries; Infarction; Necrosis; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Myocardial Ischemia; Ischemia; Femoral Fractures; Hip Injuries; Pathological Conditions, Signs and Symptoms; Behavior; Stroke; Cardiovascular Diseases; Fractures, Bone; Depression; Peripheral Arterial Disease; Hip Fractures; Myocardial Infarction; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: 4R33HL151885-02 (U.S. NIH Grant/Contract); 1U01HL122280-01A1 (U.S. NIH Grant/Contract); 1U01HL122273-01A1 (U.S. NIH Grant/Contract); RG1001184 (Other Identifier: Fred Hutchinson Cancer Center)