Physical Activity Intervention - Stanford University PI: Marcia L. Stefanick, Ph.D.

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1 A Pragmatic Trial : Physical Activity to Improve CV Health in Women 1 U01 HL Women s Health Initiative Strong & Healthy Trial Physical Activity Intervention - Stanford University PI: Marcia L. Stefanick, Ph.D. Behavioral Scientist: Abby C. King, Ph.D. Medical Director: Mark Hlatky, M.D. Data Coordinating Center FHCRC (WHI CCC) Multi-PIs: Charles Kooperberg, Ph.D. Andrea LaCroix, Ph.D. (UCSD) Co-investigators: Lesley Tinker, Ph.D.

2 Primary Hypothesis: Endurance physical activity combined with muscle strengthening, balance & flexibility exercises, and reduced sedentary behavior (sitting) will reduce major CV events (MI, stroke, CV death) in older women, compared to usual activity (Control) over 4-5 years Based on: Report of the Physical Activity Guidelines Advisory Committee, Chapter 5 Active Older Adults. Department of Health and Human Services. Implemented through: National Institutes on Aging (NIA) Primary Aim: Conduct a pragmatic trial in ~50,000 women (aged 65+ yrs) in the WHI Extension Study, for whom CV outcomes are available (WHI Medical Records Cohort or CMS linkage), randomized to a centralized physical activity intervention or usual activity (Control). Primary Safety Aim: Evaluate whether the PA intervention increases risk of total clinical fracture, hip fracture, falls, or non-cvd mortality Secondary Aim: Evaluate whether the PA intervention reduces risk of selected PA-linked secondary outcomes, potentially ameliorable through regular physical activity, of importance to maintaining independence in older women

3 Eligible based on existing data* no Randomized Consent Study Design yes Intervention *Inclusion: Alive, WHI Extension Study consent CV Outcomes available Medical Records Cohort or CMS, i.e. linkage to Medicare *Exclusions: dementia living in a nursing home self-reported inability to walk Based on Zelen. N Eng J Med ,936 WHI participants were randomized Follow, per original protocol Randomize Control Follow, per original protocol (opt out) no Passive Consent yes Follow, per original protocol Physical Activity (Go4Life ) Intervention Mailings ± IVR** (automated phone system), Website, , etc.+ live advisor, PRN ** Call out feature of Interactive Voice Response System Accelerometer Sub-study Physical Activity Study Consent Primary Outcomes: major CV events (MI, Stroke, CV Death)

4 #7: Fall Fall, 2016, Readiness New Survey for Change; Life Happens PA Cohort : Mailed out Oct 2016 N = 21,693

5 Fall 2016, New Survey PA Cohort : Mailed out Oct 2016 N = 21,693

6 #7: Fall Fall, 2016, Readiness New Survey for Change; Life Happens

7 Winter 2017

8 Winter 2017

9 #7: Winter Fall, 2017 Survey

10 #7: Fall, Survey Spring 2017

11 Spring 2017

12 #7: Spring Fall, Survey 2017

13 Summer 2017

14 #7: Fall, Survey Mailed Oct-Nov 2016: N = 21,693 2 nd mailing Jan 2017: 3 rd April 2017

15 Characteristics of WHISH PA-I group Overall N=21,692 Respondents N=10,959 (51%) Non-respondents N=10,733 (49%) N % N % N % Age at Randomization <77 years years years Race White African American Hispanic (English Speaking) Asian/Pacific Islander Native Am/Alaskan Other/Unknown Region (WHI) Northeast Southeast Midwest West

16 Characteristics of WHISH PA-I group Overall N=21,692 Respondents N=10,959 (51%) Non-respondents N=10,733 (49%) N % N % N % BMI (kg/m 2 ) < > Physical Function (SF36) < >

17 My Physical Activity Level since WHISH started has: Blue: Increased a lot or somewhat Red: Not changed; remained the same Green: Decreased somewhat or a lot Percent % 34% 35% 20 14% 21% 24% 0 < AGE

18 Walking more 3108 reported their Physical Activity level had increased since WHISH started How? [Mark all that apply] Sitting less Upper Body* Balance Lower Body* Flexibility 20 Aerobic activity Walking faster Other 0 *strengthening exercises

19 Already Regularly active 1962 reported their Physical Activity level had decreased since WHISH started. Why? [Mark all that apply] Health Lack of Issues energy/i nterest Volun -teer Too busy Materials not motivating Caregiving Fear of falling None

20 reported their Physical Activity level had remained the same since WHISH started. Why? [Mark all that apply] Already Regularly active Lack of Health energy/i Issues nterest Volun -teer Materials not motivating Too busy Caregiving Fear of falling None 0

21 Top Two Reasons you want to be physically active? Personal Health [Mark only two.] Maintain Regain Independence Enjoyment Family Social interested Not Interaction in being active Other

22 ,386 Women who answered at least 1 Survey Question Which (if any) of the following materials have helped you to become more physically active (or to maintain your physical activity level) since WHISH started Newsletter Go4 Life Pedometer Calendar Website Adriana s None

23 Adriana Women s Health Initiative Strong & Healthy (WHISH) 1 U01 HL Rebecca Renae Katie Gaelyn Drieling Jennings Weber Georgia Krauss Katelyn Abby Marcia Cynthia Valerie Fishpaw King Stefanick To McGuire

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