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NCT Number: NCT02425345

Women's Health Initiative Strong and Healthy Study

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.

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Key information

Conditions

Myocardial Infarction Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Cardiovascular Mortality Central Nervous System Diseases Cerebrovascular Disorders Clinical (Non-hip) Fractures Coronary Revascularization Depression Depressive Symptoms Falls Femoral Fractures Fractures, Bone Heart Diseases Hip Fractures Hip Injuries Infarction Ischemia Leg Injuries Mobility and Independence Mortality Motor Activity Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Artery Disease Peripheral Vascular Diseases Physical Function Sleep Stroke Vascular Diseases Venous Thromboembolic Event Wounds and Injuries

Age range

66 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality

    Time frame: median 8.7 years

    WHI centrally adjudicated events and CMS FFS-identified events. CVD defined as (first event since enrollment in WHISH of) MI, stroke, cardiovascular (CV) death.

  2. Physical Function (Physical Function Score From Self-report, RAND-36)

    Time frame: 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.

    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.

  3. Non-Cardiovascular Disease Mortality

    Time frame: median 8.7 years

    Safety. WHI centrally adjudicated events and CMS FFS-identified events.

  4. Hip Fracture

    Time frame: median 8.7 years

    Safety. WHI centrally adjudicated events and CMS FFS-identified events.

  5. Falls / Year

    Time frame: median 8.7 years

    Safety; self-report

  6. Clinical (Non-hip) Fracture

    Time frame: median 8.7 years

    Safety. Self-report

Secondary outcomes

  1. Peripheral Artery Disease

    Time frame: median 8.7 years

    WHI centrally adjudicated events and CMS FFS-identified events.

  2. Venous Thromboembolic Event

    Time frame: median 8.7 years

    WHI centrally adjudicated events and CMS FFS-identified events.

  3. Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention)

    Time frame: median 8.7 years

    Safety; adjudicated events

  4. Mobility Loss

    Time frame: median 8.7 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.

    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.

  5. Short Physical Performance Battery (SPPB)

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

    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.

  6. Sleep Disturbance

    Time frame: Annually during study years 6, 7, 8, and 9. The single value for this Outcome is based on the average of all collected measurements.

    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.

  7. Depressive Symptoms

    Time frame: Annually during study years 6, 7, 8, 9. The single value for this Outcome is based on the average of all collected measurements.

    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.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Stanford University
  • University of California, San Diego

Registry information

Acronym: WHISH

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2015
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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