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Annals of Epidemiology
Volume 13, Issue 9, Supplement,
, Pages S87-S97
Author links open overlay panelCherylRitenbaughPhD, MPHRuth EPattersonPhD, RDPersonEnvelopeRowan TChlebowskiMD, PhDBetteCaanDrPHLesleyFels-TinkerPhD, RDBarbaraHowardPhDJudyOckenePhD
The Dietary Modification (DM) component of the Women's Health Initiative (WHI) is a randomized controlled evaluation of a low-fat diet that is high in fruits, vegetables, and grains. This low-fat dietary pattern is hypothesized to reduce the risk of breast and colorectal cancer and secondarily, coronary heart disease, in postmenopausal women. To test these hypotheses, 48,836 postmenopausal women were randomly assigned to either the low-fat eating pattern (40%) or self-selected dietary behavior (60%). The nutrition goals for women in the intervention arm are to reduce energy from fat to 20% and energy from saturated fat to 7%, and to increase fruit and vegetable intake to at least five servings per day and grains to at least six servings per day. Participants will be followed for an average of 8.5 years.
The DM was motivated by animal studies 1., 2., international ecologic studies of diet and disease 3., 4., migrant studies 5., 6., 7., and epidemiologic studies (8) indicating that the diet, particularly lower levels of fat intake, has the potential to reduce risk of breast cancer, colon cancer, and heart disease. Within-country analytic epidemiologic studies of fat and breast and colorectal cancers have yielded inconsistent or null results 9., 10., 11.. However there are substantial obstacles to finding clear and interpretable relationships in these studies (12):
Current or recent fat intakes may differ from intakes during the years pertinent to the development of chronic diseases, likely attenuating associations.
Fat intakes in Western populations may not be highly variable, in spite of the variety of foods available.
It is difficult to estimate the relationship between fat intake and disease because diet is a complex mixture of foods, nutrients, and other bioactive compounds.
Dietary patterns often relate to other disease risk factors, offering the potential for confounding (or over-control) in these studies.
Considerable random, systematic, and person-specific errors exist in all available dietary assessment methods and the key measurement properties of these instruments are not well understood.
The purpose of this report is to describe the baseline characteristics of participants in the DM trial, with emphasis on sociodemographics, health behavior, medical history, dietary intake, and other factors that could relate to the clinical outcomes.
Screening and eligibility for the dietary modification trial
The WHI included postmenopausal women aged 50 to 79 years. Women with previous or existing breast cancer or invasive cancer of any type within the past 10 years were excluded. General WHI trial eligibility criteria are provided in Hays' article in this issue. The DM component also excluded women who were: 1) on a low-fat diet (<32% energy from fat); 2) had dietary needs incompatible with the intervention program (e.g. celiac sprue); 3) ate 10 or more meals per week outside the home; 4) could
Similar to the presentation of results for the other components, the baseline description of participants in the Dietary Modification trial is stratified by age. Because there was a study-wide emphasis on inclusion of minorities, all demographic, medical history, dietary intake and blood analytes are given by race/ethnicity group in the Appendix to Hays' article. Differences by age and race/ethnicity are generally statistically significant because of the large sample sizes. Therefore, we simply
Comparisons of key variables to national data
Since DM participants were not recruited as a representative sample from the US population, it is instructive to compare this sample to US women aged 50 to 79 years. Compared with women from the NHANES III, DM participants are more obese. Specifically, in the three age decades, 73%, 76%, and 73% of DM participants have BMI greater than 25 as compared with 64%, 64%, and 58% of NHANES III women (19). In contrast, DM participants have lower rates of hypertension: 28%, 38%, and 45% compared with
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- F Sacks et al.Rationale and design of the Dietary Approaches to Stop Hypertension (DASH) trial. A multicenter controlled-feeding study of dietary patterns to lower blood pressure
- T.M Vogt et al.Dietary Approaches to Stop Hypertension: Rationale, design, and methods
J Am Diet Assoc
- A.R Kristal et al.Dietary assessment instruments are susceptible to intervention-associated response set bias
J Am Diet Assoc
- A.E Black et al.Measurement of total energy expenditure provide insights into the validity of dietary measurements of energy intake
J Am Diet Assoc
- R.K Johnson et al.Literacy and body fatness are associated with underreporting of energy intake in US low-income women using the multiple-pass 24-hour recall: a doubly labeled water study
J Am Diet Assoc
- M.M Henderson et al.Feasibility of a randomized trial of a low-fat diet for the prevention of breast cancer: Dietary compliance in the Women's Health Trial vanguard study
- T Robertson et al.Epidemiologic studies of coronary heart disease and stroke in Japanese men living in Japan, Hawaii, and California: incidence of myocardial infarction and death from coronary heart disease
Am J Cardiol
- L Freedman et al.
Meta-analysis of animal experiments: elucidating relationships between dietary fat and mammary tumor development in rodents
Adv Exp Med Biol
- L Zhao et al.
Quantitative review of studies of dietary fat and rat colon carcinoma
- R.L Prentice et al.
Dietary fat and cancer: consistency of the epidemiologic data, and disease prevention that may follow from a practical reduction in fat consumption
Cancer Causes Control
Seven Countries: A multivariate analysis of death and coronary heart disease
Migration patterns and breast cancer risk in Asian-American women
J Natl Cancer Inst
Cancer in migrants to Australia: extending the descriptive epidemiological data
Dietary factors and risk of breast cancer: combined analysis of 12 case-control studies
J Natl Cancer Inst
Association of dietary intake of fat and fatty acids with risk of breast cancer
Cohort studies of fat intake and the risk of breast cancer–a pooled analysis
N Engl J Med
Dietary fat and fiber in relation to risk of breast cancer
Fat and fiber and breast cancer research-where is the field going?
Breast Cancer Res
The Women's Health Initiative: Overview of the Nutrition Components
Results of a randomized feasibility study of a low-fat diet
Arch Intern Med
The Women's Health Trial Feasibility Study in Minority Populations: Design and baseline descriptions
- Diet in different fat content and cardiometabolic health
2022, Advances in Dietary Lipids and Human Health
In the past several decades, the health effects of dietary fats on human health have been a longstanding research topic of interest. Numerous observational epidemiology studies and randomized controlled trials indicate that amounts and specific types of fat have different effects on the intermediate risk factors and incidence of cardiometabolic diseases. In countries under nutrition transition, a reduction in total dietary fat and an increase in carbohydrate consumption have paralleled the increased prevalence of obesity and cardiometabolic diseases for decades. The nutrition transition has been considered to be one of the risk factors contributing to this epidemic. We previously conducted a 6-month randomized controlled feeding trial to investigate whether a lower-fat, higher-carbohydrate diet was more effective than a higher-fat, lower-carbohydrate diet (consumed in most Western societies), for weight control and modifying cardiometabolic disease risk factors among healthy young adults. Findings from this trial indicated that a lower-fat, higher-carbohydrate diet appeared to be less likely to promote excessive weight gain than a higher-fat, lower-carbohydrate diet. The higher-fat, lower-carbohydrate diet was also associated with unfavorable changes in gut microbiota, fecal microbial metabolites, and circulating proinflammatory factors in healthy young adults. This chapter will discuss evidence from population-based studies regarding diets with different fat-to-carbohydrate ratios and cardiometabolic health and provide an overview of our previous key findings.
- Oxidative stress as a therapeutic target for the prevention and treatment of early age-related macular degeneration
2021, Survey of Ophthalmology
Age-related macular degeneration, the leading cause of irreversible visual loss among older adults in developed countries, is a chronic, multifactorial, and progressive disease with the development of painless, central vision loss. Retinal pigment epithelial cell dysfunction is a core change in age-related macular degeneration that results from aging and the accumulated effects of genetic and environmental factors that, in part, is both caused by and leads to oxidative stress. In this review, we describe the role of oxidative stress, the cytoprotective oxidative stress pathways, and the impact of oxidative stress on critical cellular processes involved in age-related macular degeneration pathobiology. We also offer targeted therapy that may define how antioxidant therapy can either prevent or improve specific stages of age-related macular degeneration.
Accuracy of self-reported weight in the Women's Health Initiative
2019, Public Health Nutrition
Role of dietary patterns and acculturation in cancer risk and mortality among postmenopausal Hispanic women: results from the Women’s Health Initiative (WHI)
2022, Journal of Public Health (Germany)
Social Isolation and Incident Heart Failure Hospitalization in Older Women: Women’s Health Initiative Study Findings
2022, Journal of the American Heart Association
Research articleRecruitment challenges in a diabetes prevention trial in a low- and middle-income setting
Diabetes Research and Clinical Practice, Volume 110, Issue 1, 2015, pp. 51-59
To describe recruitment challenges in a randomized controlled translational trial (RCTT) of diabetes prevention in India.
The Diabetes Community Lifestyle Improvement Program (D-CLIP) is a RCTT, comparing standard of care to a step-wise model of diabetes prevention. Overweight adults with prediabetes were identified through a two-step screening process (1) field-based screening: minimal testing with a random capillary glucose measurement and (2) clinic-based screening including an Oral Glucose Tolerance Test (OGTT).
Individuals from the community (n=19377) were screened at residential locations, offices, educational institutions, places of worship, parks and beaches. Of these, 3535 (18.2%) ‘high-risk’ participants based on capillary glucose values were eligible for step 2 screening with OGTT. However, only 21.5% participated. An additional 521 participants directly entered step 2 via direct referrals from our clinical/research databases, study participant referrals and targeted advertisements. Of the 1285 individuals who underwent an OGTT, 710 (55.3%) were eligible for randomization, and 602 (84.8%) were randomized into the trial. The ratio of participants entering from step 1 to step 2 was 25:1 (3.9%) and from step 2 to randomization 2:1 (47%). Average staff time for recruitment was 350h per week for an 11-person team.
Nearly 55 people needed to be screened with a questionnaire plus capillary glucose test to randomize one participant with prediabetes. Using a 2-step strategy requires additional staff time, but considerably reduces the need for OGTT's, thereby minimizing participant burden and study costs.
Research articleRelationship between measures of central and general adiposity with aortic stiffness in the general population
Atherosclerosis, Volume 235, Issue 2, 2014, pp. 625-631
Increased aortic stiffness may be one of the mechanisms by which obesity increases cardiovascular risk independently of traditional risk factors. While body mass index (BMI) is generally used to define excess adiposity, several studies have suggested that measures of central obesity may be better predictors of cardiovascular risk. However, data comparing the association between several measures of central and general obesity with aortic stiffness in the general population are inconclusive.
In 1031 individuals (age 53±13 years, 45% men) without manifest cardiovascular disease randomly selected from population, we tested the association between parameters of central obesity (waist circumference – WC, waist-to-hip-ratio – WHR, waist-to-height ratio – WHtR) and general obesity (BMI) with carotid-femoral pulse wave velocity (cfPWV).
In univariate analysis, WC and WHtR were more strongly associated with cfPWV than BMI in both genders, while WHR showed a stronger association with cfPWV only in women. WHtR was more closely associated with cfPVW than WHR. This difference between obesity measures remained after multivariate adjustment. When the fully adjusted hierarchical regression was used, among central obesity measures, WHtR had the largest additive value on top of BMI, while there was no additive value of BMI on top of WHtR.
Central obesity parameters are more closely associated with aortic stiffness than BMI. Of central adiposity measures, WHtR has the strongest association with aortic stiffness beyond body mass index and cardiovascular risk factors. Our results suggest that WHtR may be the best anthropometric measure of excess adiposity in the general population.
Research articleMarkers of a recent bocavirus infection in children with Kawasaki disease: “A year prospective study”
Pathologie Biologie, Volume 62, Issue 6, 2014, pp. 365-368
Retrospective studies and case-reports have suggested the possible role of various viruses in the pathogenesis of the Kawasaki disease.
To determine prospectively the incidence of Kawasaki diseases associated with a recent bocavirus infection in the course of a year.
Thirty-two children with Kawasaki disease were enrolled in a 13months prospective study to assess the frequency of human bocavirus type 1 infections. Seasonal shedding of virus, markers of recent infection such as viraemia, viral load, and serum interferon alpha were analyzed.
Three of 32 (9%) children had HBoV-DNA in the serum suggesting a recent infection. HBoV-DNA was detected in naso-pharyngeal aspiration of 7/32 (21.8%) children with Kawasaki Disease and six of them (18%) had an increased viral load. No common respiratory viruses were isolated from the 32 patients with the exception of one adenovirus. The seven bocaviruses were identified during the winter-spring season. In addition, 4 of 7 of Kawasaki disease patients shedding bocavirus had detectable interferon alpha in the blood, indicating a possible active or recent viral infection.
This study shows that a recent bocavirus infection is concomitant with the onset of some cases of Kawasaki disease. Bocavirus may be a cofactor in the pathogenesis of this disease as previously reported for other infectious agents.
Plusieurs études suggèrent le rôle de différents virus dans la pathogenèse de la maladie de Kawasaki.
Déterminer de façon prospective l’incidence d’une infection récente à bocavirus associée à l’apparition d’une maladie de Kawasaki.
Sur une période de 13mois, 32enfants développant une maladie de Kawasaki ont été recrutés dans une étude prospective à la recherche d’une infection récente à bocavirus. Le portage du virus en fonction de la saison, les marqueurs d’une infection récente: charge virale, virémie, interferonémie ont été analysés.
L’ADN du bocavirus a été détecté dans 3sérums sur 32 (9%) des enfants suggérant ainsi une infection récente. Sept patients sont porteurs d’ADN viral dans les aspirations naso-pharyngées mais avec une charge virale à des valeurs faibles ou modérées. Excepté un adénovirus isolé chez un 8e patient, les cultures virales et les tests par immunofluoresence sont restés négatifs. Sept bocavirus ont été identifiés dans la période hiver–printemps et aucun parmi les 6cas de maladies de Kawasaki observés dans la période été automne. De plus, 4/7 patients porteurs de bocavirus avaient une interferonémie positive qui est en faveur d’une infection virale récente.(Video) Health Affairs Briefing: Type 2 Diabetes: Policies To Improve Prevention, Care And Outcomes
Cette étude démontre qu’au moins 9% des maladies de Kawasaki se déclare au cours ou à la suite d’une infection récente à bocavirus, Ces virus pourraient donc être un cofacteur dans la pathogénie de cette maladie au même titre que d’autres agents infectieux déjà rapportés.
Research articleChange in motor function and adverse health outcomes in older African-Americans
Experimental Gerontology, Volume 70, 2015, pp. 71-77
We tested whether declining motor function accelerates with age in older African-Americans.
Eleven motor performances were assessed annually in 513 older African-Americans.
During follow-up of 5years, linear mixed-effect models showed that motor function declined by about 0.03units/year (Estimate, −0.026, p<0.001); about 4% more rapidly for each additional year of age at baseline. A proportional hazard model showed that both baseline motor function level and its rate of change were independent predictors of death and incident disability (all p's<0.001). These models showed that the additional annual amount of motor decline in 85year old persons at baseline versus 65year old persons was associated with a 1.5-fold higher rate of death and a 3-fold higher rate of developing Katz disability.
The rate of declining motor function accelerates with increasing age and its rate of decline predicts adverse health outcomes in older African-Americans.
Research articleLow Apgar scores at 5 minutes in a low risk population: Maternal and obstetrical factors and postnatal outcome
Revista da Associação Médica Brasileira, Volume 58, Issue 5, 2012, pp. 587-593
To evaluate the association between Apgar scores of less than seven at five minutes (AS5min < 7) and antenatal factors and postnatal outcomes.
A retrospective cohort and case-control study of 27,252 consecutive term newborns in a low risk obstetrical population between January 2003 and December 2010. Maternal and infant databases were reviewed from all cases with AS5min < 7 (n = 121; 0.4%) and 363 cases with AS5min ≥7 at 5 minutes who were randomly selected by a computer program. The main outcomes were neonatal death, newborn respiratory distress, need for orotracheal intubation and neonatal intensive care unit (NICU), and hypoxic-ischemic-encephalopathy.
After multiple regression analysis, repeated late decelerations on cardiotocography (OR: 2.4; 95% CI: 1.4–4.1) and prolonged second stage of labor (OR: 3.3; 95% CI: 1.3-8.3) were associated with AS5min < 7, as well as neonatal respiratory distress (OR: 3.0; 95% CI: 1.3-6.9), orotracheal intubation (OR: 2.5; 95% CI: 1.2-4.8), need for NICU (OR: 9.5; 95% CI: 6.7-16.8), and hypoxic-ischemic-encephalopathy (OR: 14.1; 95% CI: 3.6-54.7). No other antenatal factors were associated with AS5min < 7 (p > 0.05).
Repeated late decelerations and prolonged second stage of labor in the low-risk population are predictors of AS5min < 7, a situation associated with increased risk of neonatal respiratory distress, need for mechanical ventilatory support and NICU, and hypoxic-ischemic-encephalopathy.
Avaliar a associação entre índice de Apgar menor que sete no 5° minuto, os fatores pré-natais e resultados pós-natais.
Trata-se de estudo retrospectivo com 27.252 recém-nascidos em maternidade escola com população de baixo risco obstétrico, de janeiro de 2003 a dezembro de 2010. Prontuários de todos os casos com índice de Apgar < 7 no 5° minuto (n = 121; – 0,4%) e de 363 casos com Apgar ≥7 no 5° minuto, escolhidos ao acaso, foram revisados. Os principais desfechos estudados foram: óbito neonatal, insuficiência respiratória neonatal, necessidade de intubação orotraqueal e de unidade terapia intensiva (UTI) neonatal e encefalopatia hipóxico-isquêmica.
Após análise de regressão múltipla, desacelerações tardias (DIP II) (OR: 2,4; IC95%: 1,4–4,1) e período expulsivo prolongado (OR: 3,3; IC 95%: 1,3–8,3) se associaram com Apgar < 7 no 5° minuto; assim como com insuficiência respiratória ao nascimento (OR: 3,0; IC 95%: 1,3–6,9), intubação traqueal (OR: 2,5; IC 95%: 1,2–4,8), necessidade de UTI neonatal (OR: 9,5; IC 95%: 6,7–16,8) e encefalopatia hipóxico-isquêmica (OR: 14,1; IC 95%: 3,6–54,7). Nenhuma outra variável prénatal se associou com Apgar < 7 no 5° minuto (p < 0,05).
DIP II e período expulsivo prolongado estão associados com Apgar < 7 no 5° minuto em população obstétrica de baixo risco; situação essa relacionada com maior risco de insuficiência respiratória no parto, necessidade de suporte ventilatório e encefalopatia hipóxico-isquêmica.
Research articleSociodemographic and lifestyle factors as determinants of energy intake and macronutrient composition: a 10-year follow-up after bariatric surgery
Surgery for Obesity and Related Diseases, Volume 13, Issue 9, 2017, pp. 1572-1583
Early identification of the potential to adopt a long-term unhealthy diet, could improve weight outcomes for patients having undergone bariatric surgery.
We explored whether presurgical sociodemographic and lifestyle characteristics, together with the type of surgery, could predict 10-year changes in dietary intake after bariatric surgery.
Surgical departments and primary healthcare centers, nationwide.
Participants were from the Swedish Obese Subjects study, a matched (nonrandomized) prospective trial comparing bariatric surgery with standard care for obese patients. This study included the 1695 surgery patients with complete information on presurgery diet. Questionnaires were completed before and 6 months, 1–4, 6, 8, and 10 years after surgery. Analyses were conducted with linear mixed-model.
Dietary changes were observed in 1561, 1298, and 1243 participants, at the 2-, 6-, and 10-year follow-ups, respectively. Sex and treatment type predicted changes in energy, carbohydrate, protein, and fiber intake over the follow-up (P<.05). Furthermore, male sex, younger age, a sedentary behavior, and gastric bypass predicted increased alcohol consumption (P<.001). Two important phases for intervening bariatric patients’ diet were identified. The first was 6 months after surgery, when the maximal changes in diet were achieved. The second, stretched from 6 months until 4 years after surgery, during which earlier commitments to dietary changes were largely abandoned.
Male sex and banding surgery in particular predicted unfavorable post-surgery changes in energy and macronutrient intake. Furthermore, gastric bypass, a younger age, and an unhealthy lifestyle presurgery, may predispose individuals to increased alcohol intake after surgery.See AlsoCPCB | Central Pollution Control BoardA Guest's Guide to Every Kind of Wedding Dress CodeBacking Tracks for Singers | Musical & Orchestral Karaoke Tracks Online12 Dresses To Wear With Cowboy Boots 2022(Video) Nutritional Management of Metabolic Syndrome and Disorders | Indian Medical Association Pune
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