Clinical trial NCT02425345: Women's Health Initiative Strong and Healthy Study
Official title: Women's Health Initiative Strong and Healthy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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: 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
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
name: Stanford University
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2015-04-24
Enrollment: 49331
Sex: FEMALE
Minimum age (years): 66
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality
timeFrame: 9 years
measure: Non-Cardiovascular Disease Mortality
timeFrame: 9 years
measure: Hip Fracture
timeFrame: 9 years
measure: Clinical (non-hip) Fracture
timeFrame: 9 years
measure: Falls
timeFrame: 9 years
Secondary outcomes:
measure: Venous Thromboembolic Event
timeFrame: 9 years
measure: Peripheral Artery Disease
timeFrame: 9 years
measure: Physical Function (Physical Function Score from self-report)
timeFrame: 9 years
measure: Mobility and Independence (Physical Function Score from self-report)
timeFrame: 9 years
measure: Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention)
timeFrame: 9 years
measure: Short Physical Performance Battery (SPPB)
timeFrame: 4 years
measure: Sleep Disturbance
timeFrame: 4 years
measure: Depressive Symptoms
timeFrame: 4 years
Other outcomes:
Locations:
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Charles L Kooperberg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Andrea Z LaCroix, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Marcia L Stefanick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.