Women's Health Initiative Strong and Healthy Study

Stroke Clinical Trial

— WHISH  

Official title:

Women's Health Initiative Strong and Healthy Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02425345
• Other study ID #: 4R33HL151885-02
• Secondary ID: 1U01HL122280-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2, 2015
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Fred Hutchinson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49331
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 66 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Heart, Lung, and Blood Institute (NHLBI), Stanford University, University of California, San Diego

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality	Adjudicated events	9 years
Primary	Non-Cardiovascular Disease Mortality	Safety; adjudicated event	9 years
Primary	Hip Fracture	Safety; adjudicated event	9 years
Primary	Clinical (non-hip) Fracture	Safety	9 years
Primary	Falls	Safety; self-report	9 years
Secondary	Venous Thromboembolic Event	Adjudicated event	9 years
Secondary	Peripheral Artery Disease	Adjudicated event	9 years
Secondary	Physical Function (Physical Function Score from self-report)	Rand-36 Physical Function Scale. Score 0-100; a higher score indicates a more favorable health state in regards to physical functioning.	9 years
Secondary	Mobility and Independence (Physical Function Score from self-report)	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.	9 years
Secondary	Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention)	Safety; adjudicated events	9 years
Secondary	Short Physical Performance Battery (SPPB)	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.	4 years
Secondary	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.	4 years
Secondary	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.	4 years

External Links

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