N/A N=49,331 Randomized Single-blind Prevention

Women's Health Initiative Strong and Healthy Study

Myocardial Infarction · Stroke · Cardiovascular Mortality · Hip Fractures · Falls

Bottom Line

View on ClinicalTrials.gov: NCT02425345 ↗

Enrolled (actual)

49,331

Serious AEs

0.0%

Results posted

May 2026

Primary outcome: Primary: Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality — 5231; 5324 Participants — p=0.49

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Physical Activity (Behavioral)
Age: Older Adult · 66+ yrs
Sex: Female
Sponsor: Fred Hutchinson Cancer Center
Primary completion: Dec 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality	5231; 5324	0.49
PRIMARY Physical Function (Physical Function Score From Self-report, RAND-36)	59.73; 58.73	<0.001 sig
PRIMARY Non-Cardiovascular Disease Mortality	6336; 6310	0.85
PRIMARY Hip Fracture	1809; 1813	0.96
PRIMARY Falls / Year	0.55; 0.57	0.004 sig
PRIMARY Clinical (Non-hip) Fracture	6856; 7088	0.27
SECONDARY Peripheral Artery Disease	217; 211	0.67
SECONDARY Venous Thromboembolic Event	1493; 1520	0.58
SECONDARY Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention)	867; 868	0.90
SECONDARY Mobility Loss	5304; 5631	0.15
SECONDARY Short Physical Performance Battery (SPPB)	7.38; 7.37	0.86
SECONDARY Sleep Disturbance	8.26; 8.23	0.42
SECONDARY Depressive Symptoms	0.034; 0.036	0.33

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02425345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.