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Nonpharmacologic treatment of hypertension.

A variety of lifestyle modifications will lower both the blood pressure and various other cardiovascular risk factors that are frequently present in patients with hypertension. Numerous recent studies document the overall efficacy of some (weight reduction, sodium restriction, physical activity, moderation of alcohol) and the relative lack of effect of others (stress management and calcium, magnesium, and fish oil supplements). In particular, the Trials of Hypertension Prevention, Phase I (a control trial funded by the National Heart, Lung, and Blood Institute) provides important new data on the ability of these various modalities to prevent the development of hypertension, an equally or even more important goal than the reduction of already-established disease.

Humans↗

Results of a three-year trial of arterial hypertension prevention in a population of children aged 11-15 years by overweight control.

As part of a study of prevention of atherosclerosis precursors mass examinations were performed in two districts of Moscow. In the intervention district, the sample included 1123 pupils aged 11-12 years (544 boys, 579 girls), in the control district 1963 pupils (963 boys, 1000 girls) were examined. Repeat checks were performed one, 2 and 3 years after initial examination (blood pressure, body mass and height, skinfold thickness above m. triceps and below the scapula). The prevention programme addressed the whole population, with special emphasis on obese children (instruction about diet and correct feeding habits, body mass control) and their social microenvironment. Favourable results were registered, in terms of blood pressure and skinfold thickness reduction, during the first 2 years in boys; in girls diastolic BP dropped in the 1st year only, skinfold thickness was reduced in the first 2 years. Multiple regression analysis confirmed that the observed changes could be ascribed to the effect of the preventive programme.

Arteriosclerosis↗

The Hypertension Prevention Trial: assessment of the quality of blood pressure measurements.

Blood pressure variability is an important consideration in hypertension trials for determining required sample size and consequently making accurate outcome statements. The Hypertension Prevention Trial was a randomized controlled trial carried out in 1983-1986 in four US clinics on men and women with high normal diastolic blood pressure. This trial provided an opportunity to assess conditions affecting blood pressure measurement variability. Trained blood pressure observers measured systolic and diastolic blood pressures twice, 30 seconds apart, using a random-zero sphygmomanometer. The quality of blood pressure measurements was assessed by computing the variability of the two readings per participant-visit for each blood pressure observer at each study clinic. Other sources of variability investigated included observer digit preference, time of day, and ambient temperature. On the basis of data from this population, it is estimated that the standard deviation of blood pressure values can be reduced by 5% by taking two measurements per participant-visit. An additional reduction of variability can be effected by having the duplicate blood pressure measurements made by different blood pressure observers. In special instances where the range of blood pressure values is very restricted, use of the random-zero sphygmomanometer can increase or decrease the among-participant variability in blood pressure values, depending upon where the distribution of blood pressure values is centered.

Adult↗

Demographic, knowledge, physiological, and behavioral variables as predictors of compliance with dietary treatment goals in hypertension.

The Hypertension Prevention Trial (HPT) was a multicenter, randomized trial testing calorie control, sodium restriction, and potassium increases in the prevention of hypertension in 841 men and women. Thirty four variables that were potentially related to changes in urine sodium, urine potassium, and weight were examined individually and together across 3 years of treatment and maintenance sessions. Univariate and multivariate analysis did not reveal a consistent pattern of variables associated with successful attainment of treatment goals or failure to do so. Baseline levels of urine sodium, urine potassium, and weight were the variables most consistently associated with compliance. Household composition, such as number of people living in the house or marital status and control over selection and preparation of foods, was associated with compliance in sodium reduction treatments. Number of complaints about the diets were positively associated with noncompliance. Attendance at treatment sessions was generally associated with compliance especially for weight loss. Practical implications of these results are discussed.

Adult↗

Program to Avoid Cerebrovascular Events Through Systematic Electronic Tracking and Tailoring of an Eminent Risk Factor: A Randomized Trial.

BACKGROUND: Individuals residing in the southeastern United States experience disproportionately worse stroke outcomes. Although blood pressure (BP) reduction is among the most effective strategies for improving stroke outcomes, fewer than one third of survivors of stroke achieve BP control within 1 year of the index event. METHODS: The PACESETTER (Program to Avoid Cerebrovascular Events Through Systematic Electronic Tracking and Tailoring of an Eminent Risk Factor) trial enrolled patients with stroke and uncontrolled BP from 3 safety-net health care systems in South Carolina. Patients were randomized 1:1 to the PACESETTER intervention, which included a Bluetooth-enabled electronic pill tray, a BP monitor, and a smartphone application for automated data transmission of medication adherence and BP data to a central server or to usual care. The primary outcome was systolic BP <130&#x2009;mm&#x2009;Hg at 12 months, analyzed according to the intention-to-treat principle. RESULTS: The trial was stopped early due to low recruitment during the COVID-19 and funding constraints. Between September 2019 and February 2023, 120 participants were randomized to PACESETTER (n=60) or the usual care arm (n=60). At 4&#xa0;months, systolic BP <130&#x2009;mm&#x2009;Hg favored the PACESETTER arm (48.8% versus 29.3%, P=0.07), but no significant difference was observed at 12 months (50% versus 47.2%, P=0.82). CONCLUSIONS: Because the trial was terminated prematurely, the effect of the PACESETTER intervention on 12-month BP control after stroke remains uncertain. A trial completed to its full term and sufficiently powered to also evaluate key short-term end points is needed. REGISTRATION: URL: https://www.clinicalstrial.org; Unique Identifier: NCT03401489.

Aged↗

Randomized clinical trials of weight reduction in nonhypertensive persons.

Since 1987, four randomized controlled clinical trials with 872 nonhypertensive subjects have produced results on weight-reducing interventions, involving decreased caloric intake and/or increased expenditure, for effects on blood pressure (BP). The Hypertension Prevention Trial maintained a 3.5-kg net weight loss through 36 months with intake reduction alone. This program decreased BP by 2.4/1.8 mm Hg (systolic/diastolic) compared to controls, but both weight loss and blood pressure changes were smaller when combined with decreased sodium intake. A Stanford University trial achieved weight losses of 7.4 and 5.1 kg over 12 months with diet and exercise, respectively. Effects on clinic BP were in the range of 1.5 to 3.0 mm Hg and did not differ by intervention approach. The sole trial in children, conducted at University of Michigan, found similar weight loss (about 7 kg) and BP effects from limiting caloric intake over 20 weeks, regardless of inclusion of an exercise program; the latter did, however, result in greater reductions in percent body fat, heart rate, and serum insulin levels. The Primary Prevention of Hypertension trial tested a multifactor intervention including reductions in weight (mean, 2.7 kg), sodium and alcohol intake, and increased physical activity. During a 5-year period, clinic BP was reduced by 2.0/1.9 mm Hg, and the incidence of hypertension, by 52%. It is concluded that weight loss, however achieved, lowers BP in overweight nonhypertensive persons, and probably can contribute substantially to reducing the incidence of hypertension. Whether there are independent effects additive to weight loss from increasing physical activity and reducing sodium intake remains unknown.

Blood Pressure↗

Trials of hypertension prevention. Phase I design.

Phase I of the Trials of Hypertension Prevention (TOHP) was a National Heart, Lung, and Blood Institute-sponsored, 3-year, national, multicenter, randomized, controlled trial designed to test the feasibility and efficacy of three life-style (weight loss, sodium restriction, and stress management) and four nutrition supplement (calcium, magnesium, fish oil, and potassium) interventions aimed at lowering diastolic blood pressure in those whose blood pressure was initially in the high normal range (80 to 89 mm Hg). A total of 2182 volunteers were recruited and allocated to the various treatment arms, such that each hypothesis was tested with a power of 85% or higher to detect a diastolic blood pressure treatment effect of 2 mm Hg. The four nutrition supplement interventions were delivered in a double-blinded fashion and the three life-style interventions, single (observed) -blinded. Phase I was designed to provide a rigorous test of short-term lowering of blood pressure for each of the seven treatments chosen and provides the basis for planning of a subsequent long-term trial of hypertension prevention.

Adult↗

The effects of nonpharmacologic interventions on blood pressure of persons with high normal levels. Results of the Trials of Hypertension Prevention, Phase I.

OBJECTIVE: To test the short-term feasibility and efficacy of seven nonpharmacologic interventions in persons with high normal diastolic blood pressure. DESIGN: Randomized control multicenter trials. SETTING: Volunteers recruited from the community, treated and followed up at special clinics. PARTICIPANTS: Of 16,821 screenees, 2182 men and women, aged 30 through 54 years, with diastolic blood pressure from 80 through 89 mm Hg were selected. Of these, 50 did not return for follow-up blood pressure measurements. INTERVENTIONS: Three life-style change groups (weight reduction, sodium reduction, and stress management) were each compared with unmasked nonintervention controls over 18 months. Four nutritional supplement groups (calcium, magnesium, potassium, and fish oil) were each compared singly, in double-blind fashion, with placebo controls over 6 months. MAIN OUTCOME MEASURES: Primary: change in diastolic blood pressure from baseline to final follow-up, measured by blinded observers. Secondary: changes in systolic blood pressure and intervention compliance measures. RESULTS: Weight reduction intervention produced weight loss of 3.9 kg (P less than .01), diastolic blood pressure change of -2.3 mm Hg (P less than .01), and systolic blood pressure change of -2.9 mm Hg (P less than .01). Sodium reduction interventions lowered urinary sodium excretion by 44 mmol/24 h (P less than .01), diastolic blood pressure by 0.9 mm Hg (P less than .05), and systolic blood pressure by 1.7 mm Hg (P less than .01). Despite good compliance, neither stress management nor nutritional supplements reduced diastolic blood pressure or systolic blood pressure significantly (P greater than .05). CONCLUSIONS: Weight reduction is the most effective of the strategies tested for reducing blood pressure in normotensive persons. Sodium reduction is also effective. The long-term effects of weight reduction and sodium reduction, alone and in combination, require further evaluation.

Adult↗

[Practical use of mortality statistics and mass examination results by health workers in the local authority of the community].

In Kochi prefecture, the prefectural health service bureau tabulates both mortality statistics and mass examination results for each community and the tabulated report is sent annually to public health services staff in each local authority. While recognizing its limitations, methods of how to use the annual report are demonstrated. For example comparison of the mortality statistics and the mass examination results of the male population of A town, which is administered by Susaki Health Center, to that of the combined male population of all the towns administered by the health center shows that although the mortality rate for cerebrovascular disease for the A town-male population had been much higher than that of the combined male population in the early 1980's, the difference disappeared in the late 1980's. On the other hand, prevalence of systolic hypertension in the A town-male population continued to be higher than that for the combined male population in the late 1980's. Therefore hypertension prevention programs appears to still have significance in the A town-male population. Certain weaknesses exist in this annual report. In the comparison of mass examination results among different populations, the presence of selection bias of those receiving examinations should be considered. Standardization of mass examination procedures and quality controls of the examinations should also be considered. To get health workers to utilize the annual report further, the reported items should be improved. Particularly useful would be tabulation by residential subdivision and occupation.

Community Health Services↗

Attributions for dietary failures: problems reported by participants in the Hypertension Prevention Trial.

Assigned participants in the Hypertension Prevention Trial to one of four diets for a period of 3 years: (a) weight loss, (b) reduced sodium, (c) weight loss plus reduced sodium, and (d) reduced sodium plus increased potassium. At 6-month intervals, they reported problems they were having adhering to their diets. Problem attributions were coded along the dimensions of internality, stability, and controllability and were categorized as intrapersonal or extrapersonal. Attributions were found to differ by type of diet and sex of participant. Participants assigned to weight-loss groups were significantly more likely than those assigned to non-weight-loss groups to blame themselves for their problems with adherence, making characterological as opposed to external or situational attributions. Men perceived problems to be more controllable than women. Attributions did not predict weight loss, change in urinary sodium, or change in potassium excretion.

Adult↗

Weight-loss experience of black and white participants in NHLBI-sponsored clinical trials.

We examined race-specific weight-loss results from two randomized, multicenter trials; the Hypertension Prevention Trial (HPT) and the Trials of Hypertension Prevention (TOHP). Mean weight change from baseline averaged 2.2 kg less in black women than in white women during 18 mo of follow-up in TOHP and 2.7 kg less during 36 mo of follow-up in HPT. Mean weight loss averaged 2.0 kg less in black than in white men in TOHP and 1.4 kg less in HPT. Because of greater weight gain in black control subjects, a comparison of net weight loss (change in intervention minus change in control participants, within-race) showed a less marked difference than did black-white differences in weight loss within the actively treated group. Thus, relative to weight that would have been gained without the intervention, the experience of blacks and whites was more similar. Racial differences in weight loss may result from a combination of behavioral, sociocultural, biological, and programmatic factors.

Black or African American↗

Baseline characteristics of participants in phase I of the Trials of Hypertension Prevention.

Phase I of the Trials of Hypertension Prevention was designed to test the effectiveness and safety of three life-style (weight loss, sodium restriction, and stress management) and four nutrition supplement (calcium, magnesium, potassium, and fish oil) interventions in reducing diastolic blood pressure (DBP) in persons with a high-normal blood pressure. A total of 2182 persons with a DBP between 80 and 89 mm Hg met the eligibility criteria for participation in phase I and were randomized to one of the active intervention or control treatment groups. Most were white (82%), male (70%), married (76%), nonsmoking (88%), college graduate (53%), full-time employees (91%). The average blood pressure prior to entry into the trial was 124.9 mm Hg systolic and 83.8 mm Hg diastolic. A variety of baseline observations, including sociodemographic characteristics, personal and family medical history, health habits, diet, and biologic measurements, were documented before randomization and compared among the seven active intervention and control groups. As might be expected in a randomized trial of this sample size, the distribution of measured baseline characteristics was virtually identical in the treated and control groups. Based on this finding and the knowledge that randomization procedures were implemented without deviation from the phase I protocol, it is probable that unknown potential confounders were also equally distributed at entry into the study. Given the achievement of high rates of follow-up, subsequent differences in blood pressure are unlikely to have been due to baseline differences between the active treatment and control groups, and can probably be attributed to effects of the active interventions.

Adult↗

Hypertension Prevention Trial (HPT): food pattern changes resulting from intervention on sodium, potassium, and energy intake. Hypertension Prevention Trial Research Group.

The Hypertension Prevention Trial (HPT) was a multicenter randomized trial designed to assess the effects of long-term dietary changes on blood pressure in a normotensive population (diastolic blood pressure greater than or equal to 78 but less than 90 mm Hg) for a period of 3 years. The dietary treatments were reduction of sodium intake, increase of potassium intake, and decrease of energy intake. Estimates of changes in food intake were made by comparing 24-hour food records of the treatment and control participants. The participants in the treatment groups reported sodium intakes that were 30% to 40% lower than those of the controls. The restriction was achieved mainly by reducing intake of salt, meats, and grain products. Meats and grain products were still a major source of total sodium intake after treatment (41% to 47%), perhaps because of continued use of processed foods. Potassium intake was reported to be 16% to 25% higher in the treatment groups than in the controls, the increase achieved largely through increased consumption of fruits, with a lesser contribution from vegetables. Participants with higher initial body weights reported smaller increases in fruit and vegetable consumption than participants of normal weight, perhaps because of concerns about weight gain. Energy intake in the weight loss groups was 8% to 11% less than that of the controls. Men reported success in restricting calories from meats, dairy products, fats, beverages, and sugars. Women were less successful in restricting calories from most food groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Blood Pressure↗

A comparison of two automated monitors in the measurement of blood pressure reactivity. Trials of Hypertension Prevention Collaborative Research Group.

Cardiovascular reactivity is the change in blood pressure, pulse, and other parameters of cardiovascular function in response to a challenging task. During the conduct of cardiovascular reactivity protocols, researchers frequently use automated blood pressure devices to measure blood pressure reactivity. However, the accuracy of automated devices in measuring blood pressure reactivity is unknown. To investigate the accuracy and precision of the Dinamap 1846 SXP and the VitaStat 2600B in the measurement of blood pressure reactivity, we compared blood pressure reactivity recorded by the VitaStat and Dinamap with that obtained by observers using a conventional mercury sphygmomanometer. At three sites, 159 normotensive subjects performed the same task twice, once with blood pressure reactivity measured by the manual observers and once by the VitaStat (n = 79) or Dinamap (n = 80), with the order determined at random. Ratios (VitaStat/Dinamap) of aggregate within-person variance for baseline and task, systolic and diastolic blood pressures ranged from 1.53 to 4.93 (all P < 0.01), suggesting that the Dinamap has better precision than the VitaStat. For both diastolic and systolic blood pressure reactivity and for both types of automated devices, the mean differences in blood pressure reactivity between manual and automated measurements were small (range, -1.8 to 0.8 mm Hg). However, the VitaStat versus manual scatter plot of diastolic blood pressure reactivity showed greater dispersion (correlation coefficient r = 0.16, P = 0.15) than the Dinamap versus manual scatter plot (r = 0.36, P = 0.001). For systolic blood pressure reactivity, the VitaStat versus manual and Dinamap versus manual scatter plots were similar. Our data indicate that the Dinamap is superior to the VitaStat in the measurement of blood pressure reactivity. The substantial performance differences between the VitaStat and Dinamap suggest that other automated blood pressure monitors must be evaluated prior to use in cardiovascular reactivity studies.

Adult↗

Dietary sodium reduction for hypertension prevention and treatment.

Nutritional-nonpharmacological approaches for the treatment and prevention of hypertension are of great interest. Sodium reduction is one of the primary methods recommended for these purposes. The general public is interested in the reduction of dietary sodium intake and has responded with a decrease in table salt use, the purchase of lowered sodium food products, and the use of food labels to help guide food purchases. Countervailing trends in the use of convenience foods and dining out increase the difficulty for individuals to lower sodium intake. Clinical trials that have used sodium reduction alone or in combination with other lifestyle therapies have demonstrated the feasibility of reducing dietary sodium intake from 30% to 50% for up to 4 years, in a variety of populations. Trials that used lifestyle and weight loss interventions have also achieved significant reductions in body weight and alcohol consumption and increases in physical activity. A variety of studies indicate that long-term sodium reduction is feasible and that it is acceptable to patients. No negative consequences of these interventions have been observed, and in some cases improvement in the intake of other nutrients has occurred. Nonpharmacological interventions have resulted in hypertension control in significant proportions of the trial populations. These studies demonstrate that the foregoing types of interventions can significantly contribute to hypertension treatment and prevention.

Attitude to Health↗

[The efficacy of a program of arterial hypertension prevention among an organized population (the results of a 5-year observation)].

An epidemiological examination of 4323 motor transport workers made according to the program of the All-Union Cardiology Research Center, USSR AMS, revealed high arterial pressure (AP) in 22.6% of cases. The knowledge of hypertension was found to be low (34%) as was the coverage with hypotensive treatment (7.1%) and the efficacy of the latter one (1.8%). The follow-up studies (for 5 years) demonstrated the efficacy of non-medicamentous and medicamentous AP control exercised in motor transport workers. It was proved that in the principle AP might adequately be decreased and maintained for a long time at the safe level in the overwhelming majority of subjects with AP.

Age Factors↗