Women's Health Initiative Strong and Healthy Study

NCT02425345 | Completed Results DMC

• 4 other identifiers: 4R33HL151885-021U01HL122280-01A11U01HL122273-01A1RG1001184
• Study Type: interventional
• Target: 49,331
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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); Hip Fractures; Cardiovascular Mortality; Clinical (non-hip) Fractures; Sleep; Depressive Symptoms

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• Peripheral Artery Disease

  median 8.7 years

• Venous Thromboembolic Event

  median 8.7 years

• Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention)

  median 8.7 years

• Mobility Loss

  median 8.7 years

• Short Physical Performance Battery (SPPB)

  One time per participant analyzed during study year 7, 8, or 9.

Study Arms (2)

Physical Activity Intervention

EXPERIMENTAL

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

Usual Activity Control

NO INTERVENTION

Usual activity

Interventions

Physical Activity BEHAVIORAL

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.

Physical Activity Intervention

Eligibility Criteria

• Age: 66 Years - 99 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Inability to walk
• Dementia
• Residing in a nursing home

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• University of California, San Diego: collaborator
• Stanford University: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Related Publications (3)

• 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.

  PMID: 33433559 BACKGROUND

• 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.

  PMID: 38344760 DERIVED

• 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.

  PMID: 35691486 DERIVED

Related Links

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

MeSH Terms

Conditions

Myocardial Infarction; Stroke; Hip Fractures; Peripheral Arterial Disease; Fractures, Bone; Depression; Motor Activity; Cardiovascular Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Femoral Fractures; Wounds and Injuries; Hip Injuries; Leg Injuries; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Charles L Kooperberg, PhD
• Organization: Fred Hutchinson Cancer Center

clk@fredhutch.org

206.667.7808

Study Officials

• Charles L Kooperberg, PhD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

• Andrea Z LaCroix, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Marcia L Stefanick, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: April 24, 2015
• Study Start: April 2, 2015
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 31, 2026
• Results First Posted: May 13, 2026

Record last verified: 2026-04