Women's Health Initiative Strong and Healthy Study

NCT ID: NCT02425345

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49331 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-02

Study Completion Date

2024-12-31

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) Go4LifeĀ® Exercise \& Physical Activity materials 3 and WHISH developed targeted materials based on Go4LifeĀ® 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

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Conditions

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Myocardial Infarction Stroke 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

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Physical Activity

Intervention Type 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.

Usual Activity Control

Usual activity

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

66 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles L Kooperberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Andrea Z LaCroix, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Marcia L Stefanick, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

References

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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.

Reference Type BACKGROUND
PMID: 33433559 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38344760 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35691486 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/33433559/

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

Other Identifiers

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1U01HL122280-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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1U01HL122273-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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RG1001184

Identifier Type: OTHER

Identifier Source: secondary_id

4R33HL151885-02

Identifier Type: NIH

Identifier Source: org_study_id

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