Women's Health Initiative Strong and Healthy Study | NCT02425345

NCT02425345

ID	Type	Description	Link
1U01HL122280-01A1	U.S. NIH Grant/Contract		View source
1U01HL122273-01A1	U.S. NIH Grant/Contract		View source
RG1001184	Other Identifier	Fred Hutchinson Cancer Center

Status Module

Sponsor/Collaborators Module

Name	Class
University of California, San Diego	OTHER
Stanford University	OTHER
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Physical Activity Intervention	Experimental	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	Behavioral: Physical Activity
Usual Activity Control	No Intervention	Usual activity

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality	WHI centrally adjudicated events and CMS FFS-identified events. CVD defined as (first event since enrollment in WHISH of) MI, stroke, cardiovascular (CV) death.	median 8.7 years
Physical Function (Physical Function Score From Self-report, RAND-36)	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.	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.
Non-Cardiovascular Disease Mortality	Safety. WHI centrally adjudicated events and CMS FFS-identified events.	median 8.7 years
Hip Fracture	Safety. WHI centrally adjudicated events and CMS FFS-identified events.	median 8.7 years
Falls / Year	Safety; self-report	median 8.7 years
Clinical (Non-hip) Fracture	Safety. Self-report	median 8.7 years

Secondary Outcomes

Measure	Description	Time Frame
Peripheral Artery Disease	WHI centrally adjudicated events and CMS FFS-identified events.	median 8.7 years
Venous Thromboembolic Event	WHI centrally adjudicated events and CMS FFS-identified events.

Eligibility Module

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Charles L Kooperberg, PhD	Fred Hutchinson Cancer Center	Principal Investigator
Andrea Z LaCroix, PhD	University of California, San Diego	Principal Investigator
Marcia L Stefanick, PhD	Stanford University	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33433559	Background	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.
38344760	Derived	Mendoza-Vasconez AS, King AC, Chandler G, Mackey S, Follis S, Stefanick ML. Engagement With Remote Delivery Channels in a Physical Activity Intervention for Senior Women in the US. Am J Health Promot. 2024 Jun;38(5):692-703. doi: 10.1177/08901171241229537. Epub 2024 Feb 12.

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

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jan 27, 2021

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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
BG001	Usual Activity Control	Usual activity
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00024657 BG00124674 BG00249331

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Age at WHISH randomization

Mean

Standard Deviation

Years of age

Title

Denominators

Categories

Title	Measurements
	OG0005231 OG0015324

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	WHISH utilized a randomized consent design by Zelen (1979). Women were pre-screened for eligibility based on previously collected WHI data. WHISH comparison participants participated solely through their usual WHI mailed annual medical history update. WHISH intervention participants received information during the first year describing the intervention, and opportunity to request not receiving materials (3.5% opted out), though remained analyzed in intention-to-treat analysis.	Regression, Cox		0.49	Differences in clinical outcomes by outcome source were assessed by proportional hazards models with each outcome as a function of trial arm, stratified within the proportional hazards model by age strata, census region, and prevalent disease.	Hazard Ratio (HR)	0.99			2-Sided	95	0.95	1.02

Primary

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

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.

Posted

Mean

Standard Deviation

Score

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.

ID	Title	Description
OG000	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
OG001	Usual Activity Control	Usual activity

Units	Counts
Participants

Primary

Non-Cardiovascular Disease Mortality

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

Posted

Count of Participants

Participants

median 8.7 years

ID	Title	Description
OG000	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
OG001	Usual Activity Control	Usual activity

Units	Counts
Participants	OG000

Primary

Hip Fracture

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

Posted

Count of Participants

Participants

median 8.7 years

ID	Title	Description
OG000	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
OG001	Usual Activity Control	Usual activity

Units	Counts
Participants	OG000

Primary

Falls / Year

Safety; self-report

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.

Posted

Mean

Standard Deviation

Falls / year

median 8.7 years

ID	Title	Description
OG000	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
OG001	Usual Activity Control	Usual activity

Units	Counts
Participants	OG000

Secondary

Peripheral Artery Disease

WHI centrally adjudicated events and CMS FFS-identified events.

Posted

Count of Participants

Participants

median 8.7 years

ID	Title	Description
OG000	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
OG001	Usual Activity Control	Usual activity

Units	Counts
Participants	OG000

Secondary

Venous Thromboembolic Event

WHI centrally adjudicated events and CMS FFS-identified events.

Posted

Count of Participants

Participants

median 8.7 years

ID	Title	Description
OG000	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
OG001	Usual Activity Control	Usual activity

Units	Counts
Participants	OG000

Secondary

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

Safety; adjudicated events

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

Posted

Count of Participants

Participants

median 8.7 years

ID	Title	Description
OG000	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
OG001	Usual Activity Control	Usual activity

Units	Counts
Participants	OG000

Secondary

Mobility Loss

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.

Posted

Number

Events

median 8.7 years

ID	Title	Description
OG000	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
OG001	Usual Activity Control	Usual activity

Units	Counts
Participants

Secondary

Short Physical Performance Battery (SPPB)

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.

Posted

Mean

Standard Deviation

Score

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

ID	Title	Description
OG000	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
OG001	Usual Activity Control	Usual activity

Units	Counts
Participants

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. Data not collected prior to 1/6/2021. The single value for this Outcome is based on the average of all collected measurements.

Posted

Mean

Standard Deviation

Score

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

ID	Title	Description
OG000	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
OG001	Usual Activity Control	Usual activity

Units	Counts

Primary

Clinical (Non-hip) Fracture

Safety. Self-report

Posted

Count of Participants

Participants

median 8.7 years

ID	Title	Description
OG000	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
OG001	Usual Activity Control	Usual activity

Units	Counts
Participants	OG000

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. Data not collected prior to 1/6/2021. The single value for this Outcome is based on the average of all collected measurements.

Posted

Mean

Standard Deviation

Score

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

ID	Title	Description
OG000	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
OG001	Usual Activity Control	Usual activity

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	9,614	24,657	0	24,657	0	24,657
EG001	Usual Activity Control	Usual activity	9,697	24,674	0	24,674	0	24,674

ID	Term
D009203	Myocardial Infarction
D020521	Stroke
D006620	Hip Fractures
D058729	Peripheral Arterial Disease
D050723	Fractures, Bone
D003863	Depression
D009043	Motor Activity
D002318	Cardiovascular Diseases

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D014652	Vascular Diseases
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D005264	Femoral Fractures
D014947	Wounds and Injuries
D025981	Hip Injuries
D007869	Leg Injuries
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D016491	Peripheral Vascular Diseases
D001526	Behavioral Symptoms
D001519	Behavior

ID	Term
D015444	Exercise

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena