WOMEN´S HEALTH STUDY: CONTINUED FOLLOW-UP

Lee I-min
Brigham And Women´s Hospitalcity: Boston country: United States (us)

Grant 5R01CA047988-21 from National Cancer Institute

Keywords: 25-hydroxyvitamin D; Address; adiponectin; aged; Ancillary Study; Androgen Receptor; Apolipoprotein A-I; apolipoprotein B-100; Arthritis; Aspirin; base; biobank; Biochemical; Biochemical Genetics; Biochemical Markers; Biological; Biological Assay; biomarker; Blood specimen; Blood Vessels; Brain hemorrhage; Breast; C-reactive protein; Cancer Etiology; cancer risk; Cardiovascular Diseases; cardiovascular disorder risk; case control; Cause of Death; Cholesterol; Chronic Disease; Clinical; Clinical Trials; cohort; Collaborations; Collection; Colon Carcinoma; Colorectal; Colorectal Cancer; Connective Tissue Diseases; cost; cost effective; Creatinine; Data; Data Quality; Data Set; Data Sources; Death, Sudden, Cardiac; density; Development; Diabetes Mellitus; disability; DNA; Dose; double-blind placebo controlled trial; energy balance; Enrollment; Environmental Risk Factor; Enzymes; Epidemiology; Evaluation; Event; Eye diseases; Failure (biologic function); Fatty acid glycerol esters; Fibrinogen; follow-up; Freezing; functional outcomes; Funding; gene environment interaction; Genes; Genetic; genetic analysis; Genetic Markers; Genetic Polymorphism; genetic resource; Genetic Risk; genetic risk factor; Genome; genome wide association study; Genomics; Genotype; Glycosylated hemoglobin A; Grant; Health; Health Professional; Hemoglobin; Hemostatic function; High Density Lipoprotein Cholesterol; Homocysteine; Homocystine; Hormones; Hypertension; Impaired cognition; Incidence; Individual; Inflammation; Intercellular Adhesion Molecules; Investigation; Ischemic Stroke; LDL Cholesterol Lipoproteins; Life Style; lifestyle factors; Lipids; Lipoprotein (a); Mails; Malignant neoplasm of lung; Malignant Neoplasms; Mediator of activation protein; Medical; Medical History; Medical Records; Melanocortin 4 Receptor; Metabolism; Migraine; Modification; Morbidity - disease rate; Mortality Vital Statistics; Myocardial Infarction; National Heart, Lung, and Blood Institute; novel; Obesity; oncology; Outcome; Parents; Participant; Pathway interactions; Patient Self-Report; Pattern; Peripheral arterial disease; Physical activity; Plasma; Predisposition; prevent; Primary Cancer Prevention; Process; public health relevance; Publications; Questionnaires; Randomized; randomized trial; receptor; Recording of previous events; Reporting; Request for Proposals; Research; Research Infrastructure; Resources; Restless Legs Syndrome; Risk; Risk Factors; Role; RXRA gene; RXRB gene; RXRG gene; Sample Size; Sampling; Scanning; Secure; Signal Transduction; Single Nucleotide Polymorphism; Site; Smoking; Specific qualifier value; stroke; Thromboembolism; Thrombosis; Time; treatment duration; Triglycerides; United States National Institutes of Health; Validation; Variant; Variation (Genetics); Venous; Vitamin D; Vitamin E; Woman; Women`s Health

Relevance: NARRATIVE The Women´s Health Study (WHS) is an ongoing observational follow-up of the 39,876 initially healthy women who were enrolled in the WHS trial, begun in 1992, to evaluate the roles of low-dose aspirin and vitamin E in the primary prevention of cancer and cardiovascular disease (CVD). The participants have now been followed for an average of 15 years, and extensive clinical and risk factor data have been collected over that time. Biochemical and genome-wide scan data are also available for the more than 28,000 participants who provided a baseline blood sample. This proposal requests funding for 5 more years of ascertainment and validation of cancer and CVD endpoints, to allow the evaluation of clinically important questions related to the influence of lifestyle, biochemical markers, genetic markers, and gene-environment interactions on cancer and CVD risk

Project start date: 1991-02-01

Project end date: 2014-12-31

Budget start date: 1-JAN-2012

Budget end date: 31-DEC-2012

5R01CA047988-21 (2012): $1664698

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WOMEN´S HEALTH STUDY: CONTINUED FOLLOW-UP

Lee I-min, Senior Epidemiologist
Brigham And Women´s Hospitalcity: Boston country: United States (us)

Grant 5R01CA047988-20 from National Cancer Institute

Abstract: This proposal seeks funding to continue observational follow-up of the 39,876 Women´s Health Study (WHS) participants for an additional 5 years, with the overarching aim of accruing and validating a substantially increased number of both cancer and cardiovascular disease (CVD) endpoints to evaluate clinically important questions related to lifestyle, biochemical markers, genetic markers, and gene-environment interactions. At a very low incremental cost per participant, an added 5 years of observational follow-up will increase total cancer and CVD endpoints by 57% to 86% over the numbers occurring in the first 15 years of the study. The WHS began in 1992 as a randomized trial of aspirin and vitamin E in the primary prevention of cancer and CVD among 39,876 female health professionals aged e45 years, ending in 2004 after a mean of 10 years. Pre-randomization blood samples provided by >28,000 participants were processed, frozen, and stored, and federal and non-federal funding has allowed the conduct of extensive plasma biomarker analyses and a whole genome association scan (GWAS). Women are now followed observationally with yearly endpoint and risk factor questionnaires. After 15 years, morbidity follow-up is well over 90% and mortality follow-up is virtually 100%. Endpoint validation is up to date, with review of 89-95% of medical records completed for self-reported cancer and CVD endpoints. Thus, this study represents an extremely rich resource of high-quality data for studying important health concerns in women. In addition to the overarching aim, the proposal specifically seeks to evaluate questions that have not had adequate sample sizes to date. For cancer, we will investigate aspects of energy balance, vitamin D metabolism, and colorectal cancer risk by examining (1) the interaction between obesity and physical activity on colon cancer risk; (2) obesity-associated gene variants and colorectal cancer risk; (3) the associations of adiponectin, related gene variants, and colorectal cancer risk; and (4) gene variants related to vitamin D metabolism and colorectal cancer. For CVD, the application seeks to evaluate clinical, biochemical, and genetic risk factors for subtypes of stroke and functional outcomes from stroke in women, an understudied group. With an additional 5 years of endpoints, power will now be adequate to address these questions. Finally, augmenting the existing WHS biorepository with additional cancer and CVD endpoints will allow continued fruitful collaborations with cancer, CVD, and genomic consortia to answer questions regarding genetic and environmental risk factors and gene-environment interactions (the WHS has 44 completed and 36 currently funded ancillary studies). Failure to secure an additional 5 years of endpoints will jeopardize not only the parent study, but also all ancillary studies as well as the ability to capitalize on this enormously valuable data resource and GWAS already available. 1 The Women´s Health Study (WHS) is an ongoing observational follow-up of the 39,876 initially healthy women who were enrolled in the WHS trial, begun in 1992, to evaluate the roles of low-dose aspirin and vitamin E in the primary prevention of cancer and cardiovascular disease (CVD). The participants have now been followed for an average of 15 years, and extensive clinical and risk factor data have been collected over that time. Biochemical and genome-wide scan data are also available for the more than 28,000 participants who provided a baseline blood sample. This proposal requests funding for 5 more years of ascertainment and validation of cancer and CVD endpoints, to allow the evaluation of clinically important questions related to the influence of lifestyle, biochemical markers, genetic markers, and gene-environment interactions on cancer and CVD risk. 1

Project start date: 1991-02-01

Project end date: 2014-12-31

Budget start date: 1-JAN-2011

Budget end date: 31-DEC-2011

PFA/PA: PA-07-070

5R01CA047988-20 (2011): $1808081

Grants awarded to Lee I-min

OBJECTIVELY MEASURED PHYSICAL ACTIVITY AND MORTALITY IN WOMEN

Lee I-min
Brigham And Women´s Hospitalcity: Boston country: United States (us)

Grant 1R01CA154647-01 from National Cancer Institute

Abstract: This proposal seeks funding to measure physical activity objectively using the Actigraph GT3X accelerometer, a device that can accurately measure movement accelerations in three planes, among 21,249 women in the Women´s Health Study and to follow them over 4 years for mortality. Already available are data from annual questionnaires over 15 years on risk factors (including self-reported physical activity every 2-3 years) and medical history in women, as well as plasma biomarker and whole genome scan data from blood samples collected at baseline. Morbidity follow-up is well over 90% and mortality follow-up is virtually 100%. In 2008, the federal government released its first-ever Physical Activity Guidelines for Americans, recommending the types and amounts of physical activity believed to offer substantial health benefits. The basis for these guidelines comes almost exclusively from observational epidemiologic studies of clinical endpoints, with physical activity assessed by self-report. Supporting such studies are data from randomized controlled trials of supervised exercise and cardiovascular risk factors, providing plausible biologic underpinnings for the lower risks of chronic diseases with physical activity. However, national surveys using self-reported physical activity show 47-50% of American adults meet physical activity recommendations, but national surveys measuring physical activity objectively using accelerometers indicate that <5% do so. Additionally, recent data suggest that sedentary behavior (e.g., time sitting) may be an independent risk factor, separate from physical activity, for chronic diseases. Sedentary behavior is imprecisely measured using self- reports, but can be accurately determined using accelerometers. Thus, the present proposal seeks to clarify the relations between physical activity, as well as sedentary behavior, and mortality by objectively measuring physical activity and sedentary behavior. Women will be asked to wear the Actigraph accelerometer for 1 week. Women will be recruited on a rolling basis over 2 years. Data from the accelerometers will classify women according to the time spent in light, moderate, and vigorous intensity physical activity (or combinations thereof), and sedentary behavior. At the end of the study, we will use the National Death Index to ascertain decedents. We will have sufficient statistical power to determine associations between physical activity, or sedentary behavior, and all-cause mortality. We also will be able to compare self-reported and accelerometer-measured physical activity, providing useful data on measurement error correction for other epidemiologic studies which may not have the resources to objectively measure physical activity. Finally, this study will be of tremendous advantage for future grant applications to cost- efficiently address the associations of objectively measured physical activity with other clinical endpoints which will accumulate in sufficient numbers over time, such as incident cardiovascular disease, cancer, and type 2 diabetes, all major causes of morbidity and mortality, as well as to examine physical activity-gene interactions. 1 The federal government in 2008 recommended the types and amounts of physical activity believed to offer substantial health benefits, based primarily on observational epidemiologic studies of clinical endpoints, with physical activity assessed via self-report. However, there appears to be a large disparity between self-reported physical activity and objectively measured physical activity national surveys using self-reports show 47-50% of American adults meet physical activity recommendations, but national surveys measuring physical activity objectively using accelerometers indicate that <5% do so. The present study seeks to clarify knowledge on the association of physical activity with health by objectively measuring physical activity using accelerometers among 21,249 women, and following them over 4 years for mortality. 1

Keywords: 21+ years old; Acceleration; Active Follow-up; Address; Adult; adult human (21+); adult onset diabetes; American; Applications Grants; base; Behavior; Biochemical Genetics; biomarker; Blood Plasma; Blood Pressure, High; Blood Sample; Blood specimen; body movement; cancer type; cardiac disease risk; cardiac disorder risk; Cardiovascular Diseases; cardiovascular disorder; cardiovascular risk; cardiovascular risk factor; Cause of Death; Cessation of life; Chronic Disease; chronic disease/disorder; chronic disorder; Chronic Illness; Clinical; cost; Data; Death; Devices; Diabetes Mellitus, Adult-Onset; Diabetes Mellitus, Ketosis-Resistant; Diabetes Mellitus, Non-Insulin-Dependent; Diabetes Mellitus, Noninsulin Dependent; Diabetes Mellitus, Slow-Onset; Diabetes Mellitus, Stable; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type II; Dose; Energy Expenditure; Energy Metabolism; Epidemiologic Research; Epidemiologic Studies; Epidemiological Studies; Epidemiology Research; Epidemiology, Personal Medical History; Exercise; Exercise, Physical; Federal Government; Female Health; follow-up; Frequencies (time pattern); Frequency; Funding; Future; gene interaction; Genetic, Biochemical; genome wide association scan; genome wide association studies; genome wide association study; genome-wide scan; genomewide association scan; genomewide association studies; genomewide association study; genomewide scan; Grant Proposals; Grants, Applications; Guidelines; GWAS; Health; Health Benefit; heart disease risk; heart disorder risk; High Prevalence; Human, Adult; Hydrogen Oxide; hyperpiesia; hyperpiesis; Hypertension; hypertensive disease; indexing; Individual; ketosis resistant diabetes; Knowledge; Label; Light; maturity onset diabetes; Maturity-Onset Diabetes Mellitus; Measurement; Measures; Medical History; meetings; men; men`s; MODY; Morbidity; Morbidity - disease rate; Mortality; Mortality Vital Statistics; Movement; National Government; national surveillance; NIDDM; Non-Insulin Dependent Diabetes; Non-Insulin-Dependent Diabetes Mellitus; Observational Study; Patient Self-Report; Personal Medical History; Persons; Photoradiation; Physical activity; Physical assessment; physical conditioning; Plasma; premature; Primary Prevention; Public Health; public health medicine (field); public health relevance; Questionnaires; randomized controlled study; Randomized Controlled Trials; randomized trial; Recommendation; recruit; Recruitment Activity; Reporting; Research Resources; Resources; response; Reticuloendothelial System, Serum, Plasma; Risk; Risk Factors; Risk Reduction; sedentary; Self-Report; Serum, Plasma; Smoker; Smoking; Supervision; Survey Instrument; Surveys; T2D; T2DM; Time; Type 2 diabetes; Type II diabetes; Vascular Hypertensive Disease; Vascular Hypertensive Disorder; Water; whole genome association studies; whole genome association study; Woman; Women`s Health

Relevance: NARRATIVE The federal government in 2008 recommended the types and amounts of physical activity believed to offer substantial health benefits, based primarily on observational epidemiologic studies of clinical endpoints, with physical activity assessed via self-report. However, there appears to be a large disparity between self-reported physical activity and objectively measured physical activity: national surveys using self-reports show 47-50% of American adults meet physical activity recommendations, but national surveys measuring physical activity objectively using accelerometers indicate that <5% do so. The present study seeks to clarify knowledge on the association of physical activity with health by objectively measuring physical activity using accelerometers among 21,249 women, and following them over 4 years for mortality. 1

Project start date: 2011-01-12

Project end date: 2014-12-31

Budget start date: 12-JAN-2011

Budget end date: 31-DEC-2011

PFA/PA: PA-10-067

1R01CA154647-01 (2011): $403630