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Objective To examine the traditional diet-heart hypothesis through recovery and analysis of previously unpublished data from the Minnesota Coronary Experiment (MCE) and to put findings in the context of existing diet-heart randomized controlled trials through a systematic review and meta-analysis.Design The MCE (1968-73) is a double blind randomized controlled trial designed to test whether replacement of saturated fat with vegetable oil rich in linoleic acid reduces coronary heart disease and death by lowering serum cholesterol. Recovered MCE unpublished documents and raw data were analyzed according to hypotheses prespecified by original investigators. Further, a systematic review and meta-analyses of randomized controlled trials that lowered serum cholesterol by providing vegetable oil rich in linoleic acid in place of saturated fat without confounding by concomitant interventions was conducted.Setting One nursing home and six state mental hospitals in Minnesota, United States.Participants Unpublished documents with completed analyses for the randomized cohort of 9423 women and men aged 20-97; longitudinal data on serum cholesterol for the 2355 participants exposed to the study diets for a year or more; 149 completed autopsy files.Interventions Serum cholesterol lowering diet that replaced saturated fat with linoleic acid (from corn oil and corn oil polyunsaturated margarine). Control diet was high in saturated fat from animal fats, common margarines, and shortenings.Main outcome measures Death from all causes; association between changes in serum cholesterol and death; and coronary atherosclerosis and myocardial infarcts detected at autopsy.Results The intervention group had significant reduction in serum cholesterol compared with controls (mean change from baseline −13.8% v −1.0%; P<0.001). Kaplan Meier graphs showed no mortality benefit for the intervention group in the full randomized cohort or for any prespecified subgroup. There was a 22% higher risk of death for each 30 mg/dL (0.78 mmol/L) reduction in serum cholesterol in covariate adjusted Cox regression models (hazard ratio 1.22, 95% confidence interval 1.14 to 1.32; P<0.001). There was no evidence of benefit in the intervention group for coronary atherosclerosis or myocardial infarcts. Systematic review identified five randomized controlled trials for inclusion (n=10 808). In meta-analyses, these cholesterol lowering interventions showed no evidence of benefit on mortality from coronary heart disease (1.13, 0.83 to 1.54) or all cause mortality (1.07, 0.90 to 1.27).Conclusions Available evidence from randomized controlled trials shows that replacement of saturated fat in the diet with linoleic acid effectively lowers serum cholesterol but does not support the hypothesis that this translates to a lower risk of death from coronary heart disease or all causes. Findings from the Minnesota Coronary Experiment add to growing evidence that incomplete publication has contributed to overestimation of the benefits of replacing saturated fat with vegetable oils rich in linoleic acid.

Background Non-Hispanic black (NHB) infants are twice as likely as non-Hispanic white infants to experience rapid weight gain in the first 6 months, yet few trials have targeted this population. The current study tests the efficacy of “Mothers & Others,” a home-based intervention for NHB women and their study partners versus an attention-control, on infant size and growth between birth and 15 months. Methods Mothers & Others was a two-group randomized controlled trial conducted between November 2013 and December 2017 with enrollment at 28-weeks pregnancy and follow-up at 3-, 6-, 9-, 12-, and 15-months postpartum. Eligible women self-identified as NHB, English-speaking, and 18–39 years. The obesity prevention group (OPG) received anticipatory guidance (AG) on responsive feeding and care practices and identified a study partner, who was encouraged to attend home visits. The injury prevention group (IPG) received AG on child safety and IPG partners only completed study assessments. The primary delivery channel for both groups was six home visits by a peer educator (PE). The planned primary outcome was mean weight-for-length z-score. Given significant differences between groups in length-for-age z-scores, infant weight-for-age z-score (WAZ) was used in the current study. A linear mixed model, using an Intent-To-Treat (ITT) data set, tested differences in WAZ trajectories between the two treatment groups. A non-ITT mixed model tested for differences by dose received. Results Approximately 1575 women were screened for eligibility and 430 were enrolled. Women were 25.7 ± 5.3 years, mostly single (72.3%), and receiving Medicaid (74.4%). OPG infants demonstrated lower WAZ than IPG infants at all time points, but differences were not statistically significant (WAZ diff  = − 0.07, 95% CI − 0.40 to 0.25, p  = 0.659). In non-ITT models, infants in the upper end of the WAZ distribution at birth demonstrated incremental reductions in WAZ for each home visit completed, but the overall test of the interaction was not significant ( F 2,170  = 1.41, p  = 0.25). Conclusions Despite rich preliminary data and a strong conceptual model, Mothers & Others did not produce significant differences in infant growth. Results suggest a positive impact of peer support in both groups. Trial registration ClinicalTrials.gov, NCT01938118 , 09/10/2013.

Background Pharmacologic treatments are efficacious in reducing post-myocardial infarction (MI) morbidity and mortality. The potential influence of socioeconomic factors on the receipt of pharmacologic therapy has not been systematically examined, even though healthcare utilization likely influences morbidity and mortality post-MI. This study aims to investigate the association between socioeconomic factors and receipt of evidence-based treatments post-MI in a community surveillance setting. Methods We evaluated the association of census tract-level neighborhood household income (nINC) and Medicaid coverage with pharmacologic treatments (aspirin, beta [β]-blockers and angiotensin converting enzyme [ACE] inhibitors; optimal therapy, defined as receipt of two or more treatments) received during hospitalization or at discharge among 9,608 MI events in the ARIC community surveillance study (1993-2002). Prevalence ratios (PR, 95% CI), adjusted for the clustering of hospitalized MI events within census tracts and within patients, were estimated using Poisson regression. Results Seventy-eight percent of patients received optimal therapy. Low nINC was associated with a lower likelihood of receiving β-blockers (0.93, 0.87-0.98) and a higher likelihood of receiving ACE inhibitors (1.13, 1.04-1.22), compared to high nINC. Patients with Medicaid coverage were less likely to receive aspirin (0.92, 0.87-0.98), compared to patients without Medicaid coverage. These findings were independent of other key covariates. Conclusions nINC and Medicaid coverage may be two of several socioeconomic factors influencing the complexities of medical care practice patterns.

Declines in case fatality post–myocardial infarction (MI) have been observed over the past 3 decades. Few studies report socioeconomic disparities in survival post-MI. We assessed 1-year case fatality among 9,116 incident MI patients included in the Atherosclerosis Risk in Communities community surveillance from 1992 to 2002. Addresses of hospitalized MI patients were geocoded by a commercial vendor and linked to year 2000 United States Census tract-level neighborhood income (nINC) data. We estimated case fatality odds ratios and 95% CIs with a multinomial logistic model to quantify the association between nINC tertile and case fatality, comparing short- (within 28 days) and long-term (29-365 days) case fatality to no death 1 year post-MI. Overall, 1-year age-adjusted case fatality rates were highest among MI patients living in low-nINC areas, followed by medium- and high-nINC areas, respectively. We found significant odds ratio modification by race (P < .10) and formed race-nINC strata with high-nINC whites as the referent group. In multivariable models adjusting for age, gender, study community, and year of MI, low-nINC whites and low- and medium-nINC blacks had higher short-term case fatality than high-nINC whites. Low- and medium-nINC blacks had higher long-term case fatality compared with high-nINC whites. Differences in short- and long-term case fatality by neighborhood socioeconomic factors have not been systematically studied in the United States. Surveillance efforts can be expanded to incorporate measures of the neighborhood context to examine these associations over time.

AbstractObjectiveTo determine whether dietary interventions that increase n-3 fatty acids with and without reduction in n-6 linoleic acid can alter circulating lipid mediators implicated in headache pathogenesis, and decrease headache in adults with migraine.DesignThree arm, parallel group, randomized, modified double blind, controlled trial.SettingAmbulatory, academic medical center in the United States over 16 weeks.Participants182 participants (88% women, mean age 38 years) with migraines on 5-20 days per month (67% met criteria for chronic migraine).InterventionsThree diets designed with eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and linoleic acid altered as controlled variables: H3 diet (n=61)—increase EPA+DHA to 1.5 g/day and maintain linoleic acid at around 7% of energy; H3-L6 diet (n=61)—increase n-3 EPA+DHA to 1.5 g/day and decrease linoleic acid to ≤1.8% of energy; control diet (n=60)—maintain EPA+DHA at <150 mg/day and linoleic acid at around 7% of energy. All participants received foods accounting for two thirds of daily food energy and continued usual care.Main outcome measuresThe primary endpoints (week 16) were the antinociceptive mediator 17-hydroxydocosahexaenoic acid (17-HDHA) in blood and the headache impact test (HIT-6), a six item questionnaire assessing headache impact on quality of life. Headache frequency was assessed daily with an electronic diary.ResultsIn intention-to-treat analyses (n=182), the H3-L6 and H3 diets increased circulating 17-HDHA (log ng/mL) compared with the control diet (baseline-adjusted mean difference 0.6, 95% confidence interval 0.2 to 0.9; 0.7, 0.4 to 1.1, respectively). The observed improvement in HIT-6 scores in the H3-L6 and H3 groups was not statistically significant (−1.6, −4.2 to 1.0, and −1.5, −4.2 to 1.2, respectively). Compared with the control diet, the H3-L6 and H3 diets decreased total headache hours per day (−1.7, −2.5 to −0.9, and −1.3, −2.1 to −0.5, respectively), moderate to severe headache hours per day (−0.8, −1.2 to −0.4, and −0.7, −1.1 to −0.3, respectively), and headache days per month (−4.0, −5.2 to −2.7, and −2.0, −3.3 to −0.7, respectively). The H3-L6 diet decreased headache days per month more than the H3 diet (−2.0, −3.2 to −0.8), suggesting additional benefit from lowering dietary linoleic acid. The H3-L6 and H3 diets altered n-3 and n-6 fatty acids and several of their nociceptive oxylipin derivatives in plasma, serum, erythrocytes or immune cells, but did not alter classic headache mediators calcitonin gene related peptide and prostaglandin E2.ConclusionsThe H3-L6 and H3 interventions altered bioactive mediators implicated in headache pathogenesis and decreased frequency and severity of headaches, but did not significantly improve quality of life.Trial registrationClinicalTrials.gov NCT02012790

Background Heart failure is sometimes incorrectly listed as the underlying cause of death (UCD) on death certificates, thus compromising the accuracy and comparability of mortality statistics. Statistical redistribution of the UCD has been used to examine the effect of misclassification of the UCD attributed to heart failure, but sex- and race-specific redistribution of deaths on coronary heart disease (CHD) mortality in the United States has not been examined. Methods We used coarsened exact matching to infer the UCD of vital records with heart failure as the UCD from 1999 to 2010 for decedents 55 years old and older from states encompassing regions under surveillance by the Atherosclerosis Risk in Communities (ARIC) Study (Maryland, Minnesota, Mississippi, and North Carolina). Records with heart failure as the UCD were matched on decedent characteristics (five-year age groups, sex, race, education, year of death, and state) to records with heart failure listed among the multiple causes of death. Each heart failure death was then redistributed to plausible UCDs proportional to the frequency among matched records. Results After redistribution the proportion of deaths increased for CHD, chronic obstructive pulmonary disease, diabetes, hypertensive heart disease, and cardiomyopathy, P  < 0.001. The percent increase in CHD mortality after redistribution was the highest in Mississippi (12%) and lowest in Maryland (1.6%), with variations by year, race, and sex. Redistribution proportions for CHD were similar to CHD death classification by a panel of expert reviewers in the ARIC study. Conclusions Redistribution of ill-defined UCD would improve the accuracy and comparability of mortality statistics used to allocate public health resources and monitor mortality trends.

Objective To evaluate the effectiveness of replacing dietary saturated fat with omega 6 linoleic acid, for the secondary prevention of coronary heart disease and death.Design Evaluation of recovered data from the Sydney Diet Heart Study, a single blinded, parallel group, randomized controlled trial conducted in 1966-73; and an updated meta-analysis including these previously missing data.Setting Ambulatory, coronary care clinic in Sydney, Australia.Participants 458 men aged 30-59 years with a recent coronary event.Interventions Replacement of dietary saturated fats (from animal fats, common margarines, and shortenings) with omega 6 linoleic acid (from safflower oil and safflower oil polyunsaturated margarine). Controls received no specific dietary instruction or study foods. All non-dietary aspects were designed to be equivalent in both groups.Outcome measures All cause mortality (primary outcome), cardiovascular mortality, and mortality from coronary heart disease (secondary outcomes). We used an intention to treat, survival analysis approach to compare mortality outcomes by group.Results The intervention group (n=221) had higher rates of death than controls (n=237) (all cause 17.6% v 11.8%, hazard ratio 1.62 (95% confidence interval 1.00 to 2.64), P=0.05; cardiovascular disease 17.2% v 11.0%, 1.70 (1.03 to 2.80), P=0.04; coronary heart disease 16.3% v 10.1%, 1.74 (1.04 to 2.92), P=0.04). Inclusion of these recovered data in an updated meta-analysis of linoleic acid intervention trials showed non-significant trends toward increased risks of death from coronary heart disease (hazard ratio 1.33 (0.99 to 1.79); P=0.06) and cardiovascular disease (1.27 (0.98 to 1.65); P=0.07).Conclusions Advice to substitute polyunsaturated fats for saturated fats is a key component of worldwide dietary guidelines for coronary heart disease risk reduction. However, clinical benefits of the most abundant polyunsaturated fatty acid, omega 6 linoleic acid, have not been established. In this cohort, substituting dietary linoleic acid in place of saturated fats increased the rates of death from all causes, coronary heart disease, and cardiovascular disease. An updated meta-analysis of linoleic acid intervention trials showed no evidence of cardiovascular benefit. These findings could have important implications for worldwide dietary advice to substitute omega 6 linoleic acid, or polyunsaturated fats in general, for saturated fats.Trial registration Clinical trials NCT01621087.

Reports from large studies using administrative data sets and event registries have characterized recent temporal trends and treatment patterns for acute myocardial infarction. However, few were population based, and fewer examined differences in patterns of treatment for patients presenting with ST-segment elevation myocardial infarction (STEMI) and non–ST-segment elevation myocardial infarction (NSTEMI). The aim of this study was to examine 22-year trends in the use of 10 medical therapies and procedures by STEMI and NSTEMI classification in 30,986 definite or probable myocardial infarctions in the Atherosclerosis Risk in Communities (ARIC) Community Surveillance Study from 1987 to 2008. Weighted multivariate Poisson regression, controlling for gender, race and center classification, age, and Predicting Risk of Death in Cardiac Disease Tool score, was used to estimate average annual percentage changes in medical therapy use. From 1987 to 2008, 6,106 hospitalized events (19.7%) were classified as STEMIs and 20,302 (65.5%) as NSTEMIs. Among patients with STEMIs, increases were noted in the use of angiotensin-converting enzyme inhibitors (6.4%, 95% confidence interval [CI] 5.7 to 7.2), antiplatelet agents other than aspirin (5.0%, 95% CI 4.0% to 6.0%), lipid-lowering medications (4.5%, 95% CI 3.1% to 5.8%), β blockers (2.7%, 95% CI 2.4% to 3.0%), aspirin (1.2%, 95% CI 1.0% to 1.3%), and heparin (0.8%, 95% CI 0.4% to 1.3%). Among patients with NSTEMIs, the use of angiotensin-converting enzyme inhibitors (5.5%, 95% CI 5.0% to 6.1%), antiplatelet agents other than aspirin (3.7%, 95% CI 2.7% to 4.7%), lipid-lowering medications (3.0%, 95% CI% 1.9 to 4.1%), β blockers (4.2%, 95% CI 3.9% to 4.4%), aspirin (1.9%, 95% CI 1.6% to 2.1%), and heparin (1.7%, 95% CI 1.3% to 2.1%) increased. Among patients with STEMIs, decreases in the use of thrombolytic agents (−7.2%, 95% CI −7.9% to −6.6%) and coronary artery bypass grafting (−2.4%, 95% CI −3.6% to −1.2%) were observed. Similar increases in percutaneous coronary intervention and decreases in the use of thrombolytic agents and coronary artery bypass grafting were noted among all patients. In conclusion, trends of increasing use of evidence-based therapies were found for patients with STEMIs and those with NSTEMIs over the past 22 years.

Investigations of socioeconomic status (SES) and health during the transition to adulthood in the United States are complicated by the later and more varied transitions in residence, employment, schooling, and social roles compared with previous generations. Parental SES is an important influence during adolescence but cannot sufficiently capture the SES of the independent young adult. Typical, single SES indicators based on income or education likely misclassify the SES of young adults who have not yet completed their education or other training, or who have entered the labor force early with ultimately lower status attainment. We use a latent class analysis (LCA) framework to characterize five intergenerational SES groups, combining multidimensional SES information from two time points—that is, adolescent (parental) and young adult (self) SES data. Associations of these groups with obesity, a high-risk health outcome in young adults, revealed nuanced relationships not seen using traditional intergenerational SES measures. In males, for example, a middle-class upbringing in adolescence and continued material advantage into adulthood was associated with nearly as high obesity as a working poor upbringing and early, detrimental transitions. This intergenerational typology of early SES exposure facilitates understanding of SES and health during young adulthood.

Introduction Community mobilization (CM) is increasingly recognized as critical to generating changes in social norms and behaviours needed to achieve reductions in HIV. We conducted a CM intervention to modify negative gender norms, particularly among men, in order to reduce associated HIV risk. Methods Twenty two villages in the Agincourt Health and Socio‐Demographic Surveillance Site in rural Mpumalanga, South Africa were randomized to either a theory‐based, gender transformative, CM intervention or no intervention. Two cross‐sectional, population‐based surveys were conducted in 2012 (pre‐intervention, n = 600 women; n = 581 men) and 2014 (post‐intervention, n = 600 women; n = 575 men) among adults ages 18 to 35 years. We used an intent‐to‐treat (ITT) approach using survey regression cluster‐adjusted standard errors to determine the intervention effect by trial arm on gender norms, measured using the Gender Equitable Mens Scale (GEMS), and secondary behavioural outcomes. Results Among men, there was a significant 2.7 point increase (Beta Coefficient 95% CI: 0.62, 4.78, p = 0.01) in GEMS between those in intervention compared to control communities. We did not observe a significant difference in GEMS scores for women by trial arm. Among men and women in intervention communities, we did not observe significant differences in perpetration of intimate partner violence (IPV), condom use at last sex or hazardous drinking compared to control communities. The number of sex partners in the past 12 months (AOR 0.29, 95% CI 0.11 to 0.77) were significantly lower in women in intervention communities compared to control communities and IPV victimization was lower among women in intervention communities, but the reduction was not statistically significant (AOR 0.53, 95% CI 0.24 to 1.16). Conclusion Community mobilization can reduce negative gender norms among men and has the potential to create environments that are more supportive of preventing IPV and reducing HIV risk behaviour. Nevertheless, we did not observe that changes in attitudes towards gender norms resulted in desired changes in risk behaviours suggesting that more time may be necessary to change behaviour or that the intervention may need to address behaviours more directly. Clinical Trials number ClinicalTrials.gov NCT02129530.