Cardiovascular Mortality, Clinical (Non-hip) Fractures, Coronary Revascularization, Depressive Symptoms, Falls, Hip Fractures, Mobility and Independence, Mortality, Myocardial Infarction, Peripheral Artery Disease, Physical Function, Sleep, Stroke, Venous Thromboembolic Event
Conditions
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
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.
Interventions
BEHAVIORALPhysical 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.
Sponsors
Fred Hutchinson Cancer Center
University of California, San Diego
Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
66 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality | 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. |
| Physical Function (Physical Function Score From Self-report, RAND-36) | 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. |
| Non-Cardiovascular Disease Mortality | median 8.7 years | Safety. WHI centrally adjudicated events and CMS FFS-identified events. |
| Hip Fracture | median 8.7 years | Safety. WHI centrally adjudicated events and CMS FFS-identified events. |
| Falls / Year | median 8.7 years | Safety; self-report |
| Clinical (Non-hip) Fracture | median 8.7 years | Safety. Self-report |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral Artery Disease | median 8.7 years | WHI centrally adjudicated events and CMS FFS-identified events. |
| Venous Thromboembolic Event | median 8.7 years | WHI centrally adjudicated events and CMS FFS-identified events. |
| Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention) | median 8.7 years | Safety; adjudicated events |
| Mobility Loss | 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. |
| Short Physical Performance Battery (SPPB) | 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. |
| Sleep Disturbance | 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. |
| Depressive Symptoms | 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. |
Contacts
PRINCIPAL_INVESTIGATORCharles L Kooperberg, PhD
Fred Hutchinson Cancer Center
PRINCIPAL_INVESTIGATORAndrea Z LaCroix, PhD
University of California, San Diego
PRINCIPAL_INVESTIGATORMarcia L Stefanick, PhD
Stanford University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 79.8 Years of age STANDARD_DEVIATION 6.2 |
| Alcohol. drinks/week 1- <7 drinks per week | 6293 Participants |
| Alcohol. drinks/week <1 drink/week | 14736 Participants |
| Alcohol. drinks/week >=7 drinks per week | 3628 Participants |
| Antihyperlipidemic use | 13318 Participants |
| Antihypertensive use | 36330 Participants |
| Body Mass Index | 28.0 kg/m2 STANDARD_DEVIATION 5.8 |
| Coronary Artery Bypass Graft (CABG) / Percutaneous Transluminal Coronary Angioplasty (PTCA) | 1683 Participants |
| Education >= College degree | 11746 Participants |
| Education <= High school / GED | 4249 Participants |
| Education Missing | 280 Participants |
| Education School after high school | 8677 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 900 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23729 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 45 Participants |
| Heart Failure (HF) | 868 Participants |
| Myocardial Infarction (MI) | 6865 Participants |
| Physical Activity | 11.5 MET-hr/week STANDARD_DEVIATION 12.3 |
| Physical Function | 70.0 Score STANDARD_DEVIATION 25.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 104 Participants |
| Race (NIH/OMB) Asian | 423 Participants |
| Race (NIH/OMB) Black or African American | 4351 Participants |
| Race (NIH/OMB) More than one race | 291 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 38 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 524 Participants |
| Race (NIH/OMB) White | 21439 Participants |
| Sex: Female, Male Female | 49331 Participants |
| Sex: Female, Male Male | 0 Participants |
| Smoking Current | 609 Participants |
| Smoking Missing | 128 Participants |
| Smoking Never | 25275 Participants |
| Smoking Past | 11295 Participants |
| Stroke | 1042 Participants |
| US Census Region Midwest | 11488 Participants |
| US Census Region Northeast | 12050 Participants |
| US Census Region South | 14108 Participants |
| US Census Region West | 5838 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9,614 / 24,657 | 9,697 / 24,674 |
| other Total, other adverse events | 0 / 24,657 | 0 / 24,674 |
| serious Total, serious adverse events | 0 / 24,657 | 0 / 24,674 |
Outcome results
None listed