Patricia J. Elmer

Dietary Approaches to Prevent and Treat Hypertension: A Scientific Statement From the American Heart Association

A substantial body of evidence strongly supports the concept that multiple dietary factors affect blood pressure (BP). Well-established dietary modifications that lower BP are reduced salt intake, weight loss, and moderation of alcohol consumption (among those who drink). Over the past decade, increased potassium intake and consumption of dietary patterns based on the “DASH diet” have emerged as effective strategies that also lower BP. Of substantial public health relevance are findings related to blacks and older individuals. Specifically, blacks are especially sensitive to the BP-lowering effects of reduced salt intake, increased potassium intake, and the DASH diet. Furthermore, it is well documented that older individuals, a group at high risk for BP-related cardiovascular and renal diseases, can make and sustain dietary changes. The risk of cardiovascular disease increases progressively throughout the range of BP, beginning at 115/75 mm Hg. In view of the continuing epidemic of BP-related diseases and the increasing prevalence of hypertension, efforts to reduce BP in both nonhypertensive and hypertensive individuals are warranted. In nonhypertensive individuals, dietary changes can lower BP and prevent hypertension. In uncomplicated stage I hypertension (systolic BP of 140 to 159 mm Hg or diastolic BP of 90 to 99 mm Hg), dietary changes serve as initial treatment before drug therapy. In those hypertensive patients already on drug therapy, lifestyle modifications, particularly a reduced salt intake, can further lower BP. The current challenge to healthcare providers, researchers, government officials, and the general public is developing and implementing effective clinical and public health strategies that lead to sustained dietary changes among individuals and more broadly among whole populations.

Community education for cardiovascular disease prevention: risk factor changes in the Minnesota Heart Health Program.

OBJECTIVES The Minnesota Heart Health Program is a 13-year research and demonstration project to reduce morbidity and mortality from coronary heart disease in whole communities. METHODS Three pairs of communities were matched on size and type; each pair had one education site and one comparison site. After baseline surveys, a 5- to 6-year program of mass media, community organization, and direct education for risk reduction was begun in the education communities, whereas surveys continued in all sites. RESULTS Many intervention components proved effective in targeted groups. However, against a background of strong secular trends of increasing health promotion and declining risk factors, the overall program effects were modest in size and duration and generally within chance levels. CONCLUSIONS These findings suggest that even such an intense program may not be able to generate enough additional exposure to risk reduction messages and activities in a large enough fraction of the population to accelerate the remarkably favorable secular trends in health promotion activities and in most coronary heart disease risk factors present in the study communities.

Effects of comprehensive lifestyle modification on diet, weight, physical fitness, and blood pressure control: 18-month results of a randomized trial.

Context Can adults make sustained changes in unhealthy lifestyle behaviors? Content In this multicenter trial, 810 adult volunteers with prehypertension or stage 1 hypertension were randomly assigned to a multicomponent behavioral intervention group, a group combining the behavioral intervention plus the Dietary Approaches to Stop Hypertension (DASH) diet, or an advice only group. At 18 months, participants in both behavioral intervention groups had less hypertension, more weight loss, and better reduction in sodium and fat intake than those receiving advice only. The participants in the DASH diet group also increased their intake of fruits, vegetables, and fiber. Implications Motivated adults can sustain several lifestyle changes over 18 months, which might reduce their risk for cardiovascular disease. The Editors The public health burden of chronic diseases related to suboptimal diet and physical inactivity is enormous. It has been estimated that these lifestyle factors contribute to approximately 20% of deaths in the United States (1). Incidence of atherosclerotic cardiovascular disease, overweight and obesity, elevated blood pressure and lipid levels, diabetes, osteoporosis, and cancer is increased by unhealthy lifestyles (2-8). Multiple lifestyle factors, such as physical inactivity; excessive intake of calories, sodium, saturated fat, and cholesterol; and inadequate intake of fruits, vegetables, and low-fat dairy products, are etiologically related to the development of these diseases (4, 5, 8-10). To reduce the burden of chronic disease, increased physical activity and changes in diet are needed, yet few intervention studies have attempted to achieve many lifestyle changes simultaneously. The PREMIER randomized trial tested the effects of 2 multicomponent behavioral interventions on blood pressure (11). Both interventions promoted increased physical activity, weight loss, and reduced sodium intake, each of which is recommended by the 2005 Dietary Guidelines Scientific Advisory Committee (12). One intervention also added the Dietary Approaches to Stop Hypertension (DASH) diet (13). This diet, which is high in fruits, vegetables, and low-fat dairy products and low in saturated fat, total fat, and cholesterol, meets each of the major nutrient recommendations that were established by the Institute of Medicine (14-18). We report the effects of the PREMIER interventions on lifestyle changes and blood pressure status at 18 months. The main results of PREMIER, namely change in blood pressure at 6 months, were reported previously (11). Methods The PREMIER study design and rationale (19) and intervention methods (11) have been described previously. The institutional review boards at each clinical center; an external protocol review committee appointed by the National Heart, Lung, and Blood Institute (NHLBI); and the NHLBI reviewed and approved the protocol (available at www.kpchr.org/public/premier/intervention/default.asp). The NHLBI also appointed a data and safety monitoring board to monitor the trial. Each participant provided written informed consent. The trial was conducted from January 2000 through November 2002. Study Participants Participants were generally healthy adults, age 25 years or older, who had prehypertension or stage 1 hypertension and met the Joint National Committee VI (JNC VI) criteria for a 6-month trial of nonpharmacologic therapy (2). Targeted recruitment methods were used to ensure adequate representation of clinically important subgroups, in particular, African-American persons. Specific methods varied from site to site but included direct mailings, radio and newspaper advertisements, and networking within the local African-American communities. Eligibility criteria included not taking antihypertensive medication and having a systolic blood pressure of 120 to 159 mm Hg and a diastolic blood pressure of 80 to 95 mm Hg, based on the average of 3 screening visits. Persons with prehypertension (systolic blood pressure of 120 to 139 mm Hg or diastolic blood pressure of 80 to 89 mm Hg) were included because of the excess risk for cardiovascular disease in those with blood pressure within this range (20). Major exclusion criteria were a body mass index less than 18.5 kg/mg2 or greater than 45.0 kg/m2, use of antihypertensive drugs or other drugs that affect blood pressure, JNC VI risk category C (target organ damage or diabetes), use of prescription weight loss medications, previous cardiovascular event, congestive heart failure, angina, cancer, and consumption of more than 21 alcoholic drinks per week. Trial Conduct Eligible participants were randomly assigned, with equal probability, to 1 of 3 groups: an advice only comparison group (advice only); an intervention group that targeted established, guideline-recommended lifestyle recommendations (established) (2); or an intervention group targeting the established recommendations and adding the DASH dietary pattern (established plus DASH) (13). Computer-generated treatment assignments were stratified by clinic and hypertension status and were assigned in blocks of varying sizes to provide balance over time. The actual assignments were administered by using a password-protected, Web-based application developed by the coordinating center and accessible only by authorized individuals. All clinic measurement staff were blinded to treatment assignment, and all intervention staff were blinded to clinic measurements. Hypertension was defined by using the JNC VI criteria for hypertension treatment: an average systolic blood pressure of 140 mm Hg, a diastolic blood pressure greater than 90 mm Hg, or use of antihypertensive medication. Normal blood pressure was defined as systolic blood pressure less than 120 mm Hg, diastolic blood pressure less than 80 mm Hg, and no use of antihypertensive medication (21) (Figure). Intervention was provided by masters degreelevel counselors (dietitians and health educators trained in behavioral methods). The counselors were centrally trained before the start of the study, attended annual 3-day training sessions, and participated in monthly conference calls. Figure. Flow diagram of enrollment, measurements, and visit completion. Advice Only Group Participants in the advice group received advice to follow the National High Blood Pressure Education Program lifestyle recommendations for blood pressure control (2). Lifestyle recommendations included reducing weight (if overweight), following a reduced-sodium diet, engaging in regular moderate-intensity physical activity, and eating a heart-healthy diet, including the DASH diet. This advice was provided in two 30-minute individual sessions, 1 immediately after random assignment and 1 after the 6-month data collection visit. A PREMIER counselor reviewed the guidelines with the participant and provided printed educational materials and information about community resources. This intervention did not include advice to keep a food or exercise diary. Behavioral Interventions in the Established and Established plus DASH Groups Participant goals for the established and established plus DASH groups included weight loss of at least 6.8 kg (15 lb) for those with a body mass index of 25 kg/m2 or greater, at least 180 minutes per week of moderate-intensity physical activity, no more than 100 mmol per day of dietary sodium, and alcohol consumption of no more than 30 mL (1 oz) per day (2 drinks) for men and 15 mL (0.5) oz per day (1 drink) for women. Participants assigned to the established plus DASH group (but not those in the established group) also received counseling on the DASH diet, with goals for increased consumption of fruits and vegetables (9 to 12 servings/d) and low-fat dairy products (2 to 3 servings/d) and reduced consumption of saturated fat ( 7% of energy) and total fat ( 25% of energy). The intervention format, contact pattern, and behavior change strategies for the established and established plus DASH groups were identical. During the first 6 months, participants in both behavioral intervention groups attended 14 group sessions and 4 individual sessions; during months 7 to 18, they attended monthly group sessions supplemented with 3 individual counseling sessions. Throughout the trial, participants in the established and established plus DASH groups (but not those in the advice group) kept food diaries, monitored dietary calorie and sodium intakes, and recorded minutes of physical activity. Self-monitoring was used to provide individualized feedback, reinforcement, problem solving, and support. Social support for initial behavior changes and maintenance of change was provided during the group sessions. More detailed descriptions of the behavorial intervention methods are available (22). Measurements Blood pressure was assessed twice at each measurement, and systolic and diastolic blood pressures were calculated by using the mean of all available measurements (4 sets before random assignment, 3 sets at 6 and 18 months, and 1 set at 3 and 12 months). For 4 participants who were started on antihypertensive drug therapy between the 12- and 18-month visits, we obtained an official set of blood pressure measurements before initiation of therapy and used these as our 18-month blood pressure values for analysis. A similar procedure was used to obtain the 6-month blood pressure value for the 1 participant who began taking antihypertensive drugs between the 3- and 6-month visits. Two 24-hour dietary recalls, 1 obtained on a weekday and the other obtained on a weekend, were collected at baseline and at 6 and 18 months by telephone interview (23). Intakes of nutrients and food groups were calculated by using the Nutrition Data System for Research, version NDS-R 1998 (University of Minnesota, Minneapolis, Minnesota). Urinary excretion of sodium (reflecting salt intake) and potassium (reflecting fruit and vegetable intake) was obtained from 24-hour urinary collections at baseline a

Long-term Effects on Sexual Function of Five Antihypertensive Drugs and Nutritional Hygienic Treatment in Hypertensive Men and Women: Treatment of Mild Hypertension Study (TOMHS)

Problems with sexual function have been a long-standing concern in the treatment of hypertension and may influence the choice of treatment regimens and decisions to discontinue drugs. The Treatment of Mild Hypertension Study (TOMHS) provides an excellent opportunity for examination of sexual function and effects of treatment on sexual function in men and women with stage I diastolic hypertension because of the number of drug classes studied, the double-blind study design, and the long-term follow-up. TOMHS was a double-blind, randomized controlled trial of 902 hypertensive individuals (557 men, 345 women), aged 45 to 69 years, treated with placebo or one of five active drugs (acebutolol, amlodipine maleate, chlorthalidone, doxazosin maleate, or enalapril maleate). All participants received intensive lifestyle counseling regarding weight loss, dietary sodium reduction, alcohol reduction (for current drinkers), and increased physical activity. Sexual function was ascertained by physician interviews at baseline and annually during follow-up. At baseline, 14.4% of men and 4.9% of women reported a problems with sexual function. In men, 12.2% had problems obtaining and/or maintaining an erection; 2.0% of women reported a problem having an orgasm. Erection problems in men at baseline were positively related to age, systolic pressure, and previous antihypertensive drug use. The incidences of erection dysfunction during follow-up in men were 9.5% and 14.7% through 24 and 48 months, respectively, and were related to type of antihypertensive therapy. Participants randomized to chlorthalidone reported a significantly higher incidence of erection problems through 24 months than participants randomized to placebo (17.1% versus 8.1%, P = .025). Incidence rates through 48 months were more similar among treatment groups than at 24 months, with nonsignificant differences between the chlorthalidone and placebo groups. Incidence was lowest in the doxazosin group but was not significantly different from the placebo group. Incidence for acebutolol, amlodipine, and enalapril groups was similar to that in the placebo group. In many cases, erection dysfunction did not require withdrawal of medication. Disappearance of erection problems among men with problems at baseline was common in all groups but greatest in the doxazosin group. Incidence of reported sexual problems in women was low in all treatment groups. In conclusion, long-term incidence of erection problems in treated hypertensive men is relatively low but is higher with chlorthalidone treatment. Effects of erection dysfunction with chlorthalidone appear relatively early and are often tolerable, and new occurrences after 2 years are unlikely. The rate of reported sexual problems in hypertensive women is low and does not appear to differ by type of drug. Similar incidence rates of erection dysfunction in placebo and most active drug groups caution against routine attribution of erection problems to antihypertensive medication.

Nutritional Therapy for High Blood Pressure: Final Report of a Four-Year Randomized Controlled Trial— The Hypertension Control Program

A four-year trial assessed whether less severe hypertensives could discontinue antihypertensive drug therapy, using nutritional means to control blood pressure. Randomization was to three groups: group 1--discontinue drug therapy and reduce overweight, excess salt, and alcohol; group 2--discontinue drug therapy, with no nutritional program; or group 3--continue drug therapy, with no nutritional program. In groups 1 and 2 patients resumed drug therapy if pressure rose to hypertensive levels. Loss of at least 4.5 kg (10 + lb) was maintained by 30% of group 1, with a group mean loss of 1.8 kg (4 lb); sodium intake fell 36% and modest alcohol intake reduction was reported. At four years, 39% in group 1 remained normotensive without drug therapy, compared with 5% in group 2. Study findings demonstrated that nutritional therapy may substitute for drugs in a sizable proportion of hypertensives or, if drugs are still needed, can lessen some unwanted biochemical effects of drug treatment.

Effects of Reducing Dietary Saturated Fatty Acids on Plasma Lipids and Lipoproteins in Healthy Subjects: The Delta Study, Protocol 1

Few well-controlled diet studies have investigated the effects of reducing dietary saturated fatty acid (SFA) intake in premenopausal and postmenopausal women or in blacks. We conducted a multicenter, randomized, crossover-design trial of the effects of reducing dietary SFA on plasma lipids and lipoproteins in 103 healthy adults 22 to 67 years old. There were 46 men and 57 women, of whom 26 were black, 18 were postmenopausal women, and 16 were men > or =40 years old. All meals and snacks, except Saturday dinner, were prepared and served by the research centers. The study was designed to compare three diets: an average American diet (AAD), a Step 1 diet, and a low-SFA (Low-Sat) diet. Dietary cholesterol was constant. Diet composition was validated and monitored by a central laboratory. Each diet was consumed for 8 weeks, and blood samples were obtained during weeks 5 through 8. The compositions of the three diets were as follows: AAD, 34.3% kcal fat and 15.0% kcal SFA; Step 1, 28.6% kcal fat and 9.0% kcal SFA; and Low-Sat, 25.3% kcal fat and 6.1% kcal SFA. Each diet provided approximately 275 mg cholesterol/d. Compared with AAD, plasma total cholesterol in the whole group fell 5% on Step 1 and 9% on Low-Sat. LDL cholesterol was 7% lower on Step 1 and 11% lower on Low-Sat than on the AAD (both P<.01). Similar responses were seen in each subgroup. HDL cholesterol fell 7% on Step 1 and 11% on Low-Sat (both P<.01). Reductions in HDL cholesterol were seen in all subgroups except blacks and older men. Plasma triglyceride levels increased approximately 9% between AAD and Step 1 but did not increase further from Step 1 to Low-Sat. Changes in triglyceride levels were not significant in most subgroups. Surprisingly, plasma Lp(a) concentrations increased in a stepwise fashion as SFA was reduced. In a well-controlled feeding study, stepwise reductions in SFA resulted in parallel reductions in plasma total and LDL cholesterol levels. Diet effects were remarkably similar in several subgroups of men and women and in blacks. The reductions in total and LDL cholesterol achieved in these different subgroups indicate that diet can have a significant impact on risk for atherosclerotic cardiovascular disease in the total population.

Reducing Consumption of Sugar-Sweetened Beverages Is Associated With Reduced Blood Pressure A Prospective Study Among United States Adults

Background— Increased consumption of sugar-sweetened beverages (SSBs) has been associated with an elevated risk of obesity, metabolic syndrome, and type II diabetes mellitus. However, the effects of SSB consumption on blood pressure (BP) are uncertain. The objective of this study was to determine the relationship between changes in SSB consumption and changes in BP among adults. Methods and Results— This was a prospective analysis of 810 adults who participated in the PREMIER Study (an 18-month behavioral intervention trial). BP and dietary intake (by two 24-hour recalls) were measured at baseline and at 6 and 18 months. Mixed-effects models were applied to estimate the changes in BP in responding to changes in SSB consumption. At baseline, mean SSB intake was 0.9±1.0 servings per day (10.5±11.9 fl oz/d), and mean systolic BP/diastolic BP was 134.9±9.6/84.8±4.2 mm Hg. After potential confounders were controlled for, a reduction in SSB of 1 serving per day was associated with a 1.8-mm Hg (95% confidence interval, 1.2 to 2.4) reduction in systolic BP and 1.1-mm Hg (95% confidence interval, 0.7 to 1.4) reduction in diastolic BP over 18 months. After additional adjustment for weight change over the same period, a reduction in SSB intake was still significantly associated with reductions in systolic and diastolic BPs (P<0.05). Reduced intake of sugars was also significantly associated with reduced BP. No association was found for diet beverage consumption or caffeine intake and BP. These findings suggest that sugars may be the nutrients that contribute to the observed association between SSB and BP. Conclusions— Reduced consumption of SSB and sugars was significantly associated with reduced BP. Reducing SSB and sugar consumption may be an important dietary strategy to lower BP. Clinical Trial Registration— URL: http://clinicaltrials.gov. Unique identifier: NCT00000616.

Reduction in consumption of sugar-sweetened beverages is associated with weight loss: the PREMIER trial

BACKGROUND Consumption of liquid calories from beverages has increased in parallel with the obesity epidemic in the US population, but their causal relation remains unclear. OBJECTIVE The objective of this study was to examine how changes in beverage consumption affect weight change among adults. DESIGN This was a prospective study of 810 adults participating in the PREMIER trial, an 18-mo randomized, controlled, behavioral intervention trial. Measurements (weight, height, and 24-h dietary recall) were made at baseline, 6 mo, and 18 mo. RESULTS Baseline mean intake of liquid calories was 356 kcal/d (19% of total energy intake). After potential confounders and intervention assignment were controlled for, a reduction in liquid calorie intake of 100 kcal/d was associated with a weight loss of 0.25 kg (95% CI: 0.11, 0.39; P < 0.001) at 6 mo and of 0.24 kg (95% CI: 0.06, 0.41; P = 0.008) at 18 mo. A reduction in liquid calorie intake had a stronger effect than did a reduction in solid calorie intake on weight loss. Of the individual beverages, only intake of sugar-sweetened beverages (SSBs) was significantly associated with weight change. A reduction in SSB intake of 1 serving/d was associated with a weight loss of 0.49 kg (95% CI: 0.11, 0.82; P = 0.006) at 6 mo and of 0.65 kg (95% CI: 0.22, 1.09; P = 0.003) at 18 mo. CONCLUSIONS These data support recommendations to limit liquid calorie intake among adults and to reduce SSB consumption as a means to accomplish weight loss or avoid excess weight gain. This trial was registered at clinicaltrials.gov as NCT00000616.

Electronic medical record reminder improves osteoporosis management after a fracture: a randomized, controlled trial.

OBJECTIVES: Osteoporosis treatment rates after a fracture are low. This study evaluated methods to increase guideline‐recommended osteoporosis care postfracture.

Effect of lifestyle modifications on blood pressure by race, sex, hypertension status, and age

Recommendations for control of high blood pressure (BP) emphasize lifestyle modification, including weight loss, reduced sodium intake, increased physical activity, and limited alcohol consumption. The Dietary Approaches to Stop Hypertension (DASH) dietary pattern also lowers BP. The PREMIER randomized trial tested multicomponent lifestyle interventions on BP in demographic and clinical subgroups. Participants with above-optimal BP through stage 1 hypertension were randomized to an Advice Only group or one of two behavioural interventions that implement established recommendations (Est) or established recommendations plus DASH diet (Est plus DASH). The primary outcome was change in systolic BP at 6 months. The study population was 810 individuals with an average age of 50 years, 62% women, 34% African American (AA), 95% overweight/obese, and 38% hypertensive. Participants in all the three groups made lifestyle changes. Mean net reductions in systolic (S) BP in the Est intervention were 1.2 mmHg in AA women, 6.0 in AA men, 4.5 in non-AA women, and 4.2 in non-AA men. The mean effects of the Est Plus DASH intervention were 2.1, 4.6, 4.2, and 5.7 mmHg in the four race–sex subgroups, respectively. BP changes were consistently greater in hypertensives than in nonhypertensives, although interaction tests were nonsignificant. The Est intervention caused statistically significant BP reductions in individuals over and under age 50. The Est Plus DASH intervention lowered BP in both age groups, and significantly more so in older individuals. In conclusion, diverse groups of people can adopt multiple lifestyle changes that can lead to improved BP control and reduced CVD risk.