Trial Outcomes & Findings for Women's Health Initiative Strong and Healthy Study (NCT NCT02425345)

Last Updated: 2026-05-13

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

49331 participants

Primary outcome timeframe

median 8.7 years

Results posted on

2026-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	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	Usual Activity Control Usual activity
Overall Study STARTED	24657	24674
Overall Study COMPLETED	24657	24674
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

missing education n=280

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Physical Activity Intervention n=24657 Participants 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	Usual Activity Control n=24674 Participants Usual activity	Total n=49331 Participants Total of all reporting groups
Age, Continuous	79.8 Years of age STANDARD_DEVIATION 6.2 • n=24657 Participants	79.7 Years of age STANDARD_DEVIATION 6.2 • n=24674 Participants	79.7 Years of age STANDARD_DEVIATION 6.2 • n=49331 Participants
Sex: Female, Male Female	24657 Participants n=24657 Participants	24674 Participants n=24674 Participants	49331 Participants n=49331 Participants
Sex: Female, Male Male	0 Participants n=24657 Participants	0 Participants n=24674 Participants	0 Participants n=49331 Participants
Race (NIH/OMB) American Indian or Alaska Native	48 Participants n=24657 Participants	56 Participants n=24674 Participants	104 Participants n=49331 Participants
Race (NIH/OMB) Asian	452 Participants n=24657 Participants	423 Participants n=24674 Participants	875 Participants n=49331 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	16 Participants n=24657 Participants	22 Participants n=24674 Participants	38 Participants n=49331 Participants
Race (NIH/OMB) Black or African American	2190 Participants n=24657 Participants	2161 Participants n=24674 Participants	4351 Participants n=49331 Participants
Race (NIH/OMB) White	21398 Participants n=24657 Participants	21439 Participants n=24674 Participants	42837 Participants n=49331 Participants
Race (NIH/OMB) More than one race	291 Participants n=24657 Participants	311 Participants n=24674 Participants	602 Participants n=49331 Participants
Race (NIH/OMB) Unknown or Not Reported	262 Participants n=24657 Participants	262 Participants n=24674 Participants	524 Participants n=49331 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	915 Participants n=24657 Participants	900 Participants n=24674 Participants	1815 Participants n=49331 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23700 Participants n=24657 Participants	23729 Participants n=24674 Participants	47429 Participants n=49331 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	42 Participants n=24657 Participants	45 Participants n=24674 Participants	87 Participants n=49331 Participants
US Census Region Northeast	6010 Participants n=24657 Participants	6040 Participants n=24674 Participants	12050 Participants n=49331 Participants
US Census Region South	7063 Participants n=24657 Participants	7045 Participants n=24674 Participants	14108 Participants n=49331 Participants
US Census Region Midwest	5737 Participants n=24657 Participants	5751 Participants n=24674 Participants	11488 Participants n=49331 Participants
US Census Region West	5847 Participants n=24657 Participants	5838 Participants n=24674 Participants	11685 Participants n=49331 Participants
Education <= High school / GED	4249 Participants n=24657 Participants • missing education n=280	4126 Participants n=24674 Participants • missing education n=280	8375 Participants n=49331 Participants • missing education n=280
Education School after high school	8730 Participants n=24657 Participants • missing education n=280	8677 Participants n=24674 Participants • missing education n=280	17407 Participants n=49331 Participants • missing education n=280
Education >= College degree	11523 Participants n=24657 Participants • missing education n=280	11746 Participants n=24674 Participants • missing education n=280	23269 Participants n=49331 Participants • missing education n=280
Education Missing	155 Participants n=24657 Participants • missing education n=280	125 Participants n=24674 Participants • missing education n=280	280 Participants n=49331 Participants • missing education n=280
Body Mass Index	28.0 kg/m2 STANDARD_DEVIATION 5.8 • n=24642 Participants • missing BMI n=27 (intervention n=15; control n=12)	28.0 kg/m2 STANDARD_DEVIATION 5.8 • n=24662 Participants • missing BMI n=27 (intervention n=15; control n=12)	28.0 kg/m2 STANDARD_DEVIATION 5.8 • n=49304 Participants • missing BMI n=27 (intervention n=15; control n=12)
Physical Function	69.8 Score STANDARD_DEVIATION 25.6 • n=24494 Participants • missing physical function n=305 (intervention n=163; control n=142)	70.0 Score STANDARD_DEVIATION 25.6 • n=24532 Participants • missing physical function n=305 (intervention n=163; control n=142)	69.9 Score STANDARD_DEVIATION 25.6 • n=49026 Participants • missing physical function n=305 (intervention n=163; control n=142)
Smoking Never	12627 Participants n=24657 Participants • Missing Smoking n=275	12648 Participants n=24674 Participants • Missing Smoking n=275	25275 Participants n=49331 Participants • Missing Smoking n=275
Smoking Past	11295 Participants n=24657 Participants • Missing Smoking n=275	11270 Participants n=24674 Participants • Missing Smoking n=275	22565 Participants n=49331 Participants • Missing Smoking n=275
Smoking Current	607 Participants n=24657 Participants • Missing Smoking n=275	609 Participants n=24674 Participants • Missing Smoking n=275	1216 Participants n=49331 Participants • Missing Smoking n=275
Smoking Missing	128 Participants n=24657 Participants • Missing Smoking n=275	147 Participants n=24674 Participants • Missing Smoking n=275	275 Participants n=49331 Participants • Missing Smoking n=275
Alcohol. drinks/week <1 drink/week	14736 Participants n=24657 Participants	14632 Participants n=24674 Participants	29368 Participants n=49331 Participants
Alcohol. drinks/week 1- <7 drinks per week	6293 Participants n=24657 Participants	6404 Participants n=24674 Participants	12697 Participants n=49331 Participants
Alcohol. drinks/week >=7 drinks per week	3628 Participants n=24657 Participants	3638 Participants n=24674 Participants	7266 Participants n=49331 Participants
Physical Activity	11.5 MET-hr/week STANDARD_DEVIATION 12.3 • n=22373 Participants • missing physical activity n=4195 (intervention n=2284; control n=2111)	11.6 MET-hr/week STANDARD_DEVIATION 12.3 • n=22563 Participants • missing physical activity n=4195 (intervention n=2284; control n=2111)	11.6 MET-hr/week STANDARD_DEVIATION 12.3 • n=44936 Participants • missing physical activity n=4195 (intervention n=2284; control n=2111)
Myocardial Infarction (MI)	3469 Participants n=24657 Participants	3396 Participants n=24674 Participants	6865 Participants n=49331 Participants
Coronary Artery Bypass Graft (CABG) / Percutaneous Transluminal Coronary Angioplasty (PTCA)	1683 Participants n=24657 Participants	1619 Participants n=24674 Participants	3302 Participants n=49331 Participants
Stroke	1017 Participants n=24657 Participants	1042 Participants n=24674 Participants	2059 Participants n=49331 Participants
Heart Failure (HF)	891 Participants n=24657 Participants	868 Participants n=24674 Participants	1759 Participants n=49331 Participants
Antihypertensive use	18148 Participants n=24657 Participants	18182 Participants n=24674 Participants	36330 Participants n=49331 Participants
Antihyperlipidemic use	13238 Participants n=24657 Participants	13318 Participants n=24674 Participants	26556 Participants n=49331 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Physical Activity Intervention n=24657 Participants 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	Usual Activity Control n=24674 Participants Usual activity
Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality	5231 Participants	5324 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Physical Activity Intervention n=24657 Participants 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	Usual Activity Control n=24674 Participants Usual activity
Physical Function (Physical Function Score From Self-report, RAND-36)	59.73 Score Standard Deviation 26.76	58.73 Score Standard Deviation 26.82

PRIMARY outcome

Timeframe: median 8.7 years

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

Outcome measures

Outcome measures
Measure	Physical Activity Intervention n=24657 Participants 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	Usual Activity Control n=24674 Participants Usual activity
Non-Cardiovascular Disease Mortality	6336 Participants	6310 Participants

PRIMARY outcome

Timeframe: median 8.7 years

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

Outcome measures

Outcome measures
Measure	Physical Activity Intervention n=24657 Participants 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	Usual Activity Control n=24674 Participants Usual activity
Hip Fracture	1809 Participants	1813 Participants

PRIMARY outcome

Timeframe: median 8.7 years

Population: Trial average self-reported falls per year. Calculated from annual self-reported falls per year; ≥ 3 is counted as 3. Least squares mean difference, 95% CI, and p-value from a Poisson model adjusted for age, region, and study cohort.

Safety; self-report

Outcome measures

Outcome measures
Measure	Physical Activity Intervention n=24657 Participants 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	Usual Activity Control n=24674 Participants Usual activity
Falls / Year	0.55 Falls / year Standard Deviation 0.59	0.57 Falls / year Standard Deviation 0.60

PRIMARY outcome

Timeframe: median 8.7 years

Safety. Self-report

Outcome measures

Outcome measures
Measure	Physical Activity Intervention n=24657 Participants 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	Usual Activity Control n=24674 Participants Usual activity
Clinical (Non-hip) Fracture	6856 Participants	7088 Participants

SECONDARY outcome

Timeframe: median 8.7 years

WHI centrally adjudicated events and CMS FFS-identified events.

Outcome measures

Outcome measures
Measure	Physical Activity Intervention n=24657 Participants 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	Usual Activity Control n=24674 Participants Usual activity
Peripheral Artery Disease	217 Participants	211 Participants

SECONDARY outcome

Timeframe: median 8.7 years

WHI centrally adjudicated events and CMS FFS-identified events.

Outcome measures

Outcome measures
Measure	Physical Activity Intervention n=24657 Participants 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	Usual Activity Control n=24674 Participants Usual activity
Venous Thromboembolic Event	1493 Participants	1520 Participants

SECONDARY outcome

Timeframe: median 8.7 years

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

Safety; adjudicated events

Outcome measures

Outcome measures
Measure	Physical Activity Intervention n=24657 Participants 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	Usual Activity Control n=24674 Participants Usual activity
Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention)	867 Participants	868 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Physical Activity Intervention n=24657 Participants 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	Usual Activity Control n=24674 Participants Usual activity
Mobility Loss	5304 Events	5631 Events

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Physical Activity Intervention n=1820 Participants 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	Usual Activity Control n=1899 Participants Usual activity
Short Physical Performance Battery (SPPB)	7.38 Score Standard Deviation 2.70	7.37 Score Standard Deviation 2.71

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Physical Activity Intervention n=24657 Participants 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	Usual Activity Control n=24674 Participants Usual activity
Sleep Disturbance	8.26 Score Standard Deviation 3.09	8.23 Score Standard Deviation 3.11

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Physical Activity Intervention n=24657 Participants 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	Usual Activity Control n=24674 Participants Usual activity
Depressive Symptoms	0.034 Score Standard Deviation 0.108	0.036 Score Standard Deviation 0.109

Adverse Events

Physical Activity Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 9614 deaths

Usual Activity Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 9697 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Charles L Kooperberg, PhD

Fred Hutchinson Cancer Center

Phone: 206.667.7808

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place