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Background: Glycemic effects of the Women's Health Initiative (WHI) low-fat dietary intervention are unknown., Objective: Our objective was to analyze the effects of the WHI low-fat dietary intervention on serum glucose and insulin and insulin resistance up to 6 y after random assignment., Design: Postmenopausal WHI Dietary Modification trial intervention (DM-I) and comparison (DM-C) participants with blood measures at least at baseline and year 1 (n = 2263) were included. Anthropometric measures, dietary assessments, serum glucose and insulin concentrations, homeostasis model assessment of insulin resistance (HOMA-IR) measures, and quantitative insulin sensitivity check index (QUICKI) values were obtained at baseline, year 1, year 3, and year 6. Changes in measures were compared between groups at years 1, 3, and 6 overall and within stratified analyses., Results: Mean (±SD) differences in changes at year 1 between the DM-I and DM-C groups were as follows: glucose, -1.7 ± 17.9 mg/dL; insulin, -0.7 ± 5.1 μIU/mL; HOMA-IR, -0.2 ± 1.9; and QUICKI, 0.004 ± 0.019 (all P < 0.05). Similar findings resulted from repeated-measures analyses comparing the intervention and comparison groups over the 6 y. Whereas normoglycemic women at baseline had a decrease in glucose at year 1 that was 1.9 ± 17.2 mg/dL greater in the DM-I than in the DM-C group, diabetic women had an increase in glucose that was 7.9 ± 20.3 mg/dL greater in the DM-I than in the DM-C group (P for interaction <0.001)., Conclusions: A low-fat diet was not significantly associated with adverse glycemic effects up to 6 y after random assignment in postmenopausal women. However, diabetic women experienced adverse glycemic effects of the low-fat diet. This trial is registered at clinicaltrials.gov as NCT00000611.

Individuals with "metabolically benign" obesity (obesity unaccompanied by hypertension, dyslipidemia, and diabetes) are not at elevated 10-year risk of cardiovascular disease (CVD) compared to normal weight individuals. It remains unclear whether these obese individuals or normal weight individuals with clustering of cardiometabolic factors display heightened immune activity. Therefore, we characterized levels of acute-phase reactants (C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), white blood cell (WBC) count), adhesion molecules (E-selectin, vascular cell adhesion molecule-1), and coagulation products (fibrinogen, plasminogen activator inhibitor-1 (PAI-1)) among four body size phenotypes (normal weight with 0/1 vs. ≥2 metabolic syndrome components/diabetes and overweight/obesity with 0/1 vs. ≥2 metabolic syndrome components/diabetes) in cross-sectional analyses of 1,889 postmenopausal women from the Women's Health Initiative Observational Study (WHI-OS) nested case-control stroke study. Higher levels of all three inflammatory marker categories were found among women with overweight/obesity or ≥2 metabolic syndrome components or diabetes. Compared to normal weight women with 0 or 1 metabolic syndrome components, normal weight women with ≥2 metabolic syndrome components or diabetes were more likely to have ≥3 inflammatory markers in the top quartile (multivariate odds ratio (OR) 2.0, 95% confidence interval (CI): 1.3-3.0), as were overweight/obese women with 0 or 1 metabolic syndrome components (OR 2.3; 95% CI: 1.5-3.5). Overweight/obese women with ≥2 metabolic syndrome components or diabetes had the highest OR (OR 4.2; 95% CI: 2.9-5.9). Despite findings that metabolically benign obese individuals are not at increased 10-year risk of CVD compared to normal weight individuals, the current results suggest that overweight/obese women without clustering of cardiometabolic risk factors still possess abnormal levels of inflammatory markers.

Background: Nutritional epidemiology cohort studies primarily use food frequency questionnaires (FFQs). In part because FFQs are more reliable for nutrient densities than for absolute nutrient consumption, reports from association studies typically present only nutrient density measures in relation to disease risk., Methods: We used objective biomarkers to correct FFQ assessments for measurement error, and examined absolute energy and protein consumption in relation to cardiovascular disease incidence. FFQs and subsequent physician-adjudicated cardiovascular disease incidence were assessed for 80,370 postmenopausal women in the age range 50-79 years at enrollment in the comparison group of the Dietary Modification Trial or the prospective Observational Study in the Women's Health Initiative. Urinary recovery biomarkers of energy and protein were obtained from a subsample of 544 women, with concurrent FFQ information., Results: After biomarker correction, energy consumption was positively associated with coronary heart disease incidence (hazard ratio = 1.18; 95% confidence interval = 1.04-1.33, for 20% consumption increment) and protein density was inversely associated (0.85 [0.75-0.97]). The positive energy association appeared to be mediated by body fat accumulation. Ischemic stroke incidence was inversely associated with energy and protein consumption, but not with protein density., Conclusions: A positive association between energy and coronary heart disease risk can be attributed to body mass accumulation. Ischemic stroke risk is inversely associated with energy and protein consumption, possibly due to correlations between consumption and physical activity.

Background: Results of the Women's Health Initiative Randomized Controlled Dietary Modification Trial (WHI-DM) suggest that a low-fat diet may be associated with beneficial health outcomes for specific groups of women., Objective: The objective is to assess how cost-effective the WHI-DM would be if implemented as a public health intervention and under the sponsorship of private health insurers and Medicare. Breast and ovarian cancers are the health outcomes of interest., Participants: Two groups of WHI-DM participants form the target population for this analysis: participants consuming >36.8% of energy from fat at baseline, and participants at high risk for breast cancer with 32% or more of energy from fat at baseline., Methods: This study uses Markov cohort modeling, following societal and health care payer perspectives, with Monte Carlo simulations and one-way sensitivity analyses. WHI-DM records, nationally representative prices, and published estimates of medical care costs were the sources of cost information. Simulations were performed for hypothetical cohorts of women aged 50, 55, 60, 65, or 70 years at the beginning of the intervention. Effectiveness was estimated by quality-adjusted life years (QALYs) and the main outcome measure was the incremental cost-effectiveness ratio (ICER)., Results: Following the societal perspective, the ICERs for the 50-year old cohort are $13,773/QALY (95% confidence interval $7,482 to $20,916) for women consuming >36.8% of energy from fat at baseline and $10,544/QALY ($2,096 to $23,673) for women at high risk for breast cancer. The comparable ICER from a private health care payer perspective is $66,059/QALY ($30,155 to $121,087) and from a Medicare perspective, it is $15,051/QALY ($6,565 to $25,105)., Conclusions: The WHI-DM is a cost-effective strategy for the prevention of breast and ovarian cancers in the target population, from both societal and Medicare perspectives. Private health care payers have a relative short timeframe to realize a return on investment, since after age 65 years the financial benefits associated with the prevention program would accrue to Medicare. For this reason, the intervention is not cost-effective from a private health care payer perspective., (Copyright © 2011 American Dietetic Association. Published by Elsevier Inc. All rights reserved.)

Background: Recent studies have linked plasma markers of inflammation and endothelial dysfunction to type 2 diabetes mellitus (DM) development. However, the utility of these novel biomarkers for type 2 DM risk prediction remains uncertain., Methods: The Women's Health Initiative Observational Study (WHIOS), a prospective cohort, and a nested case-control study within the WHIOS of 1584 incident type 2 DM cases and 2198 matched controls were used to evaluate the utility of plasma markers of inflammation and endothelial dysfunction for type 2 DM risk prediction. Between September 1994 and December 1998, 93 676 women aged 50 to 79 years were enrolled in the WHIOS. Fasting plasma levels of glucose, insulin, white blood cells, tumor necrosis factor receptor 2, interleukin 6, high-sensitivity C-reactive protein, E-selectin, soluble intercellular adhesion molecule 1, and vascular cell adhesion molecule 1 were measured using blood samples collected at baseline. A series of prediction models including traditional risk factors and novel plasma markers were evaluated on the basis of global model fit, model discrimination, net reclassification improvement, and positive and negative predictive values., Results: Although white blood cell count and levels of interleukin 6, high-sensitivity C-reactive protein, and soluble intercellular adhesion molecule 1 significantly enhanced model fit, none of the inflammatory and endothelial dysfunction markers improved the ability of model discrimination (area under the receiver operating characteristic curve, 0.93 vs 0.93), net reclassification, or predictive values (positive, 0.22 vs 0.24; negative, 0.99 vs 0.99 [using 15% 6-year type 2 DM risk as the cutoff]) compared with traditional risk factors. Similar results were obtained in ethnic-specific analyses., Conclusion: Beyond traditional risk factors, measurement of plasma markers of systemic inflammation and endothelial dysfunction contribute relatively little additional value in clinical type 2 DM risk prediction in a multiethnic cohort of postmenopausal women.

Background: Studies of weight and health-related quality of life (HRQOL) generally focus on white populations. This analysis examines the association between clinical weight categories and physical HRQOL in five racial/ethnic groups of older women and determines the extent to which emotional/psychological (social support, caregiver burden) and physical health (diabetes, osteoarthritis) factors modify this relationship., Methods: The cross-sectional analysis, completed in 2007, used baseline data from postmenopausal women enrolled in the Women's Health Initiative (WHI) during the 5-year recruitment period (1993-1998)., Results: Of 161,393 women, 83% were non-Hispanic white, 9% were African American, 4% were Hispanic/Latina, 3% were Asian/Pacific Islander, and <1% were American Indian/Alaska Native. Obesity (body mass index [BMI] > or =30 kg/m(2)) was most common in non-Asian minority groups. Regression modeling showed higher odds of poor physical HRQOL with increasing weight category in all groups. In the total sample, these odds were at least 6 times as high in women with class 3 obesity as in women of normal weight and were only mildly attenuated after the analysis adjusted for emotional/psychological factors. Further adjustment for physical health factors made odds ratio (OR) estimates drop from 2.36 to 1.59 for class 1 obesity and from 6.96 to 3.71 for class 3 obesity. This pattern generally persisted within each racial/ethnic group., Conclusions: Heavier weight negatively affects physical HRQOL in postmenopausal women across diverse racial/ethnic backgrounds. Weight-relevant physical health factors have a greater impact on this weight-HRQOL association than do emotional/psychological factors.

Objective: Associations between dietary glycemic load (GL) and cardiovascular disease risk factors, including plasma lipoprotein/lipid levels, blood pressure, and glucose metabolism factors, in the Women's Health Initiative Observational Study were examined., Methods: A random sample of 878 Observational Study participants (postmenopausal women 50-79 y of age) with baseline blood measurements (647 white, 104 black, 127 Hispanic) was included. Dietary GL was estimated from baseline food-frequency questionnaires, which assessed dietary intake over the previous 3 mo. At the baseline visit, participants completed demographic and health habit questionnaires, fasting blood samples were collected, anthropometric measurements were completed, and blood pressure was assessed., Results: In all participants combined, GL was inversely associated with high-density lipoprotein cholesterol (P for trend = 0.004) and positively associated with log(10)-transformed triacylglycerols (P = 0.008). Although there were no statistically significant interactions of race/ethnicity with associations between GL and cardiovascular disease risk factors, stratified results were suggestive, showing that GL was positively associated with total cholesterol (P = 0.018) and low-density lipoprotein cholesterol (P = 0.038) in Hispanics. In white subjects, there was a trend of reduced high-density lipoprotein cholesterol with higher GL (P = 0.003), whereas GL was positively associated with log(10)-transformed triacylglycerols (P = 0.015). Associations between GL and high-density lipoprotein cholesterol and between GL and triacylglycerols also differed by body mass index, although the interactions were not statistically significant., Conclusion: Among these generally healthy postmenopausal women, GL was associated with high-density lipoprotein cholesterol and triacylglycerols. Suggestive effects of race/ethnicity and body mass index on these associations need to be confirmed in larger studies., (Copyright 2010 Elsevier Inc. All rights reserved.)

Few strong and consistent associations have arisen from observational studies of dietary consumption in relation to chronic disease risk. Measurement error in self-reported dietary assessment may be obscuring many such associations. Attempts to correct for measurement error have mostly used a second self-report assessment in a subset of a study cohort to calibrate the self-report assessment used throughout the cohort, under the dubious assumption of uncorrelated measurement errors between the two assessments. The use, instead, of objective biomarkers of nutrient consumption to produce calibrated consumption estimates provides a promising approach to enhance study reliability. As summarized here, we have recently applied this nutrient biomarker approach to examine energy, protein, and percent of energy from protein, in relation to disease incidence in Women's Health Initiative cohorts, and find strong associations that are not evident without biomarker calibration. A major bottleneck for the broader use of a biomarker-calibration approach is the rather few nutrients for which a suitable biomarker has been developed. Some methodologic approaches to the development of additional pertinent biomarkers, including the possible use of a respiratory quotient from indirect calorimetry for macronutrient biomarker development, and the potential of human feeding studies for the evaluation of a range of urine- and blood-based potential biomarkers, will briefly be described.

The authors previously reported equations, derived from the Nutrient Biomarker Study within the Women's Health Initiative, that produce calibrated estimates of energy, protein, and percentage of energy from protein consumption from corresponding food frequency questionnaire estimates and data on other factors, such as body mass index, age, and ethnicity. Here, these equations were applied to yield calibrated consumption estimates for 21,711 women enrolled in the Women's Health Initiative dietary modification trial comparison group and 59,105 women enrolled in the observational study. These estimates were related prospectively to total and site-specific invasive cancer incidence (1993-2005). In combined cohort analyses that do not control for body mass, uncalibrated energy was not associated with total cancer incidence or site-specific cancer incidence for most sites, whereas biomarker-calibrated energy was positively associated with total cancer (hazard ratio = 1.18, 95% confidence interval: 1.10, 1.27, for 20% consumption increase), as well as with breast, colon, endometrial, and kidney cancer (respective hazard ratios of 1.24, 1.35, 1.83, and 1.47). Calibrated protein was weakly associated, and calibrated percentage of energy from protein was inversely associated, with total cancer. Calibrated energy and body mass index associations were highly interdependent. Implications for the interpretation of nutritional epidemiology studies are described.

Evidence implicating hyperinsulinemia and insulin resistance in the etiology of colorectal cancer suggests that a diet characterized by a high glycemic index and load may increase the risk of this disease, but previous studies have yielded inconsistent results. We assessed the association between intake of total carbohydrates, sugars, fiber, and the glycemic index (GI) and glycemic load (GL) of individual diets, and risk of developing colorectal cancer among 158,800 participants in the Women's Health Initiative (WHI). We used a GI/GL database developed specifically for the WHI food-frequency questionnaire. Over an average of 7.8 years of follow-up, 1,476 incident cases of colorectal cancer were identified. Cox proportional hazards models were used to estimate the association between dietary factors classified by quintiles and risk of colorectal cancer, with adjustment for covariates. Total carbohydrate intake, glycemic index, glycemic load, and intake of sugars and fiber showed no association with colorectal cancer. Analyses by cancer subsite also yielded null results, with the exception of a borderline positive association between glycemic load and rectal cancer (HR for the highest versus lowest quintile 1.84, 95% confidence interval 0.95-3.56, p for trend 0.05). Analyses stratified by tertiles of body mass index and physical activity showed no evidence of effect modification by these factors. Results of this large study do not support of a role of a diet characterized by high glycemic index or load in colorectal carcinogenesis in postmenopausal women.

Background: Decreased fat intake with weight loss and increased exercise may reduce the risk of diabetes mellitus in persons with impaired glucose tolerance. This study was undertaken to assess the effects of a low-fat dietary pattern on incidence of treated diabetes among generally healthy postmenopausal women., Methods: A randomized controlled trial was conducted at 40 US clinical centers from 1993 to 2005, including 48,835 postmenopausal women aged 50 to 79 years. Women were randomly assigned to a usual-diet comparison group (n = 29,294 [60.0%]) or an intervention group with a 20% low-fat dietary pattern with increased vegetables, fruits, and grains (n = 19,541 [40.0%]). Self-reported incident diabetes treated with oral agents or insulin was assessed., Results: Incident treated diabetes was reported by 1303 intervention participants (7.1%) and 2039 comparison participants (7.4%) (hazard ratio, 0.96; 95% confidence interval, 0.90-1.03; P = .25). Weight loss occurred in the intervention group, with a difference between intervention and comparison groups of 1.9 kg after 7.5 years (P < .001). Subgroup analysis suggested that greater decreases in percentage of energy from total fat reduced diabetes risk (P for trend = .04), which was not statistically significant after adjusting for weight loss., Conclusions: A low-fat dietary pattern among generally healthy postmenopausal women showed no evidence of reducing diabetes risk after 8.1 years. Trends toward reduced incidence were greater with greater decreases in total fat intake and weight loss. Weight loss, rather than macronutrient composition, may be the dominant predictor of reduced risk of diabetes.

Background & Aims: An association between female hormones and symptomatic gastroesophageal reflux disease (GERD) and may be modified by obesity is suggested but not proven. Factors affecting GERD progression, however, are largely unknown., Methods: At 40 US clinical centers, postmenopausal women with hysterectomy (n = 10,739) were randomly assigned to receive 0.625 mg/d of conjugated equine estrogens or placebo. Women without hysterectomy (n = 16,608) were randomly assigned to receive estrogen plus progestin, given as 0.625 mg conjugated equine estrogens/d plus 2.5 mg medroxyprogesterone acetate/d, or placebo. We performed secondary analyses using data from these trials., Results: After 1 year, there was a trend toward a higher incidence of symptomatic GER among women randomly assigned to the estrogen treatment (4.2%) than with placebo (3.1%). The estrogen plus progestin treatment did not affect this risk. Neither treatment affected the progression of existing GER symptom. There was a dose-response association between baseline obesity, particularly as measured by waist circumference, with more than double the risk of incident symptomatic GER at 1 year among women with the largest waist circumference (>or=114 cm) compared with a normal waist circumference (70-80 cm). Weight gain at 1 year was associated with elevated risk of incident symptomatic GER. Weight loss at 1 year alleviated existing GER symptoms. No interaction between hormone therapy and obesity on symptomatic GER was observed., Conclusions: Estrogen treatment alone, but not with progestin, may cause GER symptoms in postmenopausal women. Increasing weight and girth increases the risk of developing GER symptoms, whereas weight loss alleviates existing GER symptoms. This trial was registered at www.clinicaltrials.gov as NCT00000611.

Objective: Experimental and epidemiologic studies suggest that calcium and vitamin D may reduce the risk of developing diabetes. We examined the effect of calcium plus vitamin D supplementation on the incidence of drug-treated diabetes in postmenopausal women., Research Design and Methods: The Women's Health Initiative Calcium/Vitamin D Trial randomly assigned postmenopausal women to receive 1,000 mg elemental calcium plus 400 IU of vitamin D3 daily, or placebo, in a double-blind fashion. Among 33,951 participants without self-reported diabetes at baseline, we ascertained by treatment assignment new diagnoses of diabetes treated with oral hypoglycemic agents or insulin. Effects of the intervention on fasting measurements of glucose, insulin, and insulin resistance were examined among a subset of participants., Results: Over a median follow-up time of 7 years, 2,291 women were newly diagnosed with diabetes. The hazard ratio for incident diabetes associated with calcium/vitamin D treatment was 1.01 (95% CI 0.94-1.10) based on intention to treat. This null result was robust in subgroup analyses, efficacy analyses accounting for nonadherence, and analyses examining change in laboratory measurements., Conclusions: Calcium plus vitamin D3 supplementation did not reduce the risk of developing diabetes over 7 years of follow-up in this randomized placebo-controlled trial. Higher doses of vitamin D may be required to affect diabetes risk, and/or associations of calcium and vitamin D intake with improved glucose metabolism observed in nonrandomized studies may be the result of confounding or of other components of foods containing these nutrients.

Objective: To identify predictors of dietary change to and maintenance of a low-fat eating pattern (<20% energy from fat, > or = 5 servings fruits/vegetables daily, and > or = 6 servings grains daily) among a cohort of postmenopausal women. Candidate predictors included intrapersonal, interpersonal, intervention program characteristics, and clinical center., Design: Longitudinal study within the Women's Health Initiative Dietary Modification Trial. Dietary change was evaluated after 1 year of participation in the Women's Health Initiative Dietary Modification Trial, and dietary maintenance after 3 years., Subjects: Postmenopausal women aged 50 to 79 years at baseline who were randomized to the intervention arm of the Women's Health Initiative Dietary Modification Trial (n=19,541)., Statistical Analysis: Univariate and multivariate linear regression analysis was performed and associations evaluated between candidate predictors and each of the three dietary goals: percent energy from fat, fruit/vegetable servings, and grain servings., Results: Year 1 (change) predictors of percent energy from fat (P<0.005) included being younger (beta=2.12; 70 to 79 years vs 50 to 59 years), more educated (beta=-.69; college vs high school), more optimistic (beta=-.07), attending more sessions (beta=-.69), and submitting more self-monitoring records (beta=-.74). At year 3 (maintenance), the predictors of percent energy from fat (P<0.005) included attending more sessions (beta=-.65) and submitting more self-monitoring scores (beta=-.71). The analytic model predicted 22% of the variance in fat intake at year 1 and 27% at year 3 (P<0.01)., Conclusions: The strongest predictors of dietary change and maintenance were attending intervention sessions and self-monitoring dietary intake. Novel was the finding that optimism predicted dietary change.

Consumption of foods with a high glycemic index (GI) or glycemic load (GL) is hypothesized to contribute to insulin resistance, which is associated with increased risk of diabetes mellitus, obesity, cardiovascular disease, and some cancers. However, dietary assessment of GI and GL is difficult because values are not included in standard food composition databases. Our objective was to develop a database of GI and GL values that could be integrated into an existing dietary database used for the analysis of FFQ. Food GI values were obtained from published human experimental studies or imputed from foods with a similar carbohydrate and fiber content. We then applied the values to the Women's Health Initiative (WHI) FFQ database and tested the output in a random sample of previously completed WHI FFQs. Of the 122 FFQ line items (disaggregated into 350 foods), 83% had sufficient carbohydrate (>5 g/serving) for receipt of GI and GL values. The foods on the FFQ food list with the highest GL were fried breads, potatoes, pastries, pasta, and soft drinks. The fiber content of foods had very little influence on calculated GI or GL estimates. The augmentation of this FFQ database with GI and GL values will enable etiologic investigations of GI and GL with numerous disease outcomes in the WHI and other epidemiologic studies that utilize this FFQ.

Context: Multiple epidemiologic studies and some trials have linked diet with cardiovascular disease (CVD) prevention, but long-term intervention data are needed., Objective: To test the hypothesis that a dietary intervention, intended to be low in fat and high in vegetables, fruits, and grains to reduce cancer, would reduce CVD risk., Design, Setting, and Participants: Randomized controlled trial of 48,835 postmenopausal women aged 50 to 79 years, of diverse backgrounds and ethnicities, who participated in the Women's Health Initiative Dietary Modification Trial. Women were randomly assigned to an intervention (19,541 [40%]) or comparison group (29,294 [60%]) in a free-living setting. Study enrollment occurred between 1993 and 1998 in 40 US clinical centers; mean follow-up in this analysis was 8.1 years., Intervention: Intensive behavior modification in group and individual sessions designed to reduce total fat intake to 20% of calories and increase intakes of vegetables/fruits to 5 servings/d and grains to at least 6 servings/d. The comparison group received diet-related education materials., Main Outcome Measures: Fatal and nonfatal coronary heart disease (CHD), fatal and nonfatal stroke, and CVD (composite of CHD and stroke)., Results: By year 6, mean fat intake decreased by 8.2% of energy intake in the intervention vs the comparison group, with small decreases in saturated (2.9%), monounsaturated (3.3%), and polyunsaturated (1.5%) fat; increases occurred in intakes of vegetables/fruits (1.1 servings/d) and grains (0.5 serving/d). Low-density lipoprotein cholesterol levels, diastolic blood pressure, and factor VIIc levels were significantly reduced by 3.55 mg/dL, 0.31 mm Hg, and 4.29%, respectively; levels of high-density lipoprotein cholesterol, triglycerides, glucose, and insulin did not significantly differ in the intervention vs comparison groups. The numbers who developed CHD, stroke, and CVD (annualized incidence rates) were 1000 (0.63%), 434 (0.28%), and 1357 (0.86%) in the intervention and 1549 (0.65%), 642 (0.27%), and 2088 (0.88%) in the comparison group. The diet had no significant effects on incidence of CHD (hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.90-1.06), stroke (HR, 1.02; 95% CI, 0.90-1.15), or CVD (HR, 0.98; 95% CI, 0.92-1.05). Excluding participants with baseline CVD (3.4%), the HRs (95% CIs) for CHD and stroke were 0.94 (0.86-1.02) and 1.02 (0.90-1.17), respectively. Trends toward greater reductions in CHD risk were observed in those with lower intakes of saturated fat or trans fat or higher intakes of vegetables/fruits., Conclusions: Over a mean of 8.1 years, a dietary intervention that reduced total fat intake and increased intakes of vegetables, fruits, and grains did not significantly reduce the risk of CHD, stroke, or CVD in postmenopausal women and achieved only modest effects on CVD risk factors, suggesting that more focused diet and lifestyle interventions may be needed to improve risk factors and reduce CVD risk., Clinical Trials Registration: ClinicalTrials.gov Identifier: NCT00000611.

Objective: To examine whether the effects of physical and emotional status on adherance to a low-fat (20% energy) dietary pattern are mediated by participation in an intervention program (attending sessions and self-monitoring)., Design: The Baron and Kenny mediator model, a series of 4 regression analyses, was used to evaluate whether: a) physical and emotional status predicted program participation, b) program participation predicted dietary adherence, c) physical and emotional status factors predicted dietary adherence, and, ultimately d) the effects of physical and emotional status on dietary adherence were mediated by program participation., Subjects/setting: Data from 13,277 postmenopausal women randomly assigned to the low-fat intervention arm of the Women's Health Initiative Dietary Modification Trial., Intervention: The nutrition goals for women randomly assigned to the low-fat intervention were to reduce total fat intake to 20% or less of energy from fat and to consume 5 or more fruit/vegetable servings daily and 6 or more grain servings daily., Main Outcome Measures: Year 1 program participation (degree of attending group sessions and submitting fat scores) and adherence to the low-fat dietary pattern (percent energy from fat) as predicted by baseline physical and emotional status (eight SF-36 Health Survey subscales)., Results: Participating in the dietary intervention program reduced (mediated) the negative effect of poorer mental health on dietary adherence by 15%. Additional findings included that a 10% increase in physical functioning increased session attendance by 0.4% (P<.001) and a 10% increase in mental health predicted a decrease in percent energy from fat of 0.3% (P<.001). Program participation had a marked effect on dietary adherence: a 10% increase in session attendance predicted a 1.2% decrease in percent energy from fat (P<.001)., Applications/conclusions: Understanding and using instruments to assess the physical and emotional status of a target population will help dietetic professionals promote healthful dietary change and maintenance.