SYSTEMIC HYPERTENSION

Effects of Weight Loss on Clinic and Ambulatory Blood Pressure in Normotensive Men Stephen P. Fortmann, MD, William L. Haskell, PhD, Peter D. Wood, DSC,

and the Stanford Weight Control Project Team

Obesity and physical inactivity are associated with both elevated cardiovascular risk and blood pres- sure (BP), but the interrelation of exercise, weight loss and BP is poorly understood. This study exam- ines the independent effects of exercise and weight loss on both standard clinic and automated, ambu- latory BP in 115 overweight, sedentary, normoten- sive men (aged 30 to 59 years) who were randomly assigned to control status or to lose weight over 1 year by moderate caloric restriction (dieting) or by increased caloric expenditure (exercise). Median daytime and evening BP were determined from measurements made every 20 minutes while the subjects were awake. After 1 year, the control group gained (mean f standard deviation) 0.5 f 3.8 kg while the diet group lost 6.9 f 4.4 kg and the exercise group lost 4.6 f 3.5 kg. Clinic BP de- creased similarly in all 3 groups, but daytime and evening ambulatory BP decreased in both interven- tion groups and increased in the control group. Rel- ative to the l-year change in control subjects, net change in daytime ambulatory BP averaged -2 to -3 mm Hg in both dieters and exercisers, while net change in evening ambulatory BP averaged -3 to -4 mm Hg. These changes were all statistically sig- nificant (p <0.05) when compared with control sub- jects except for daytime systolic BP in both inter- vention groups and evening diastolic BP in dieters. Weight loss achieved through caloric restriction or expenditure may cause important decreases in BP in normotensive men; exercise appears to confer no unique benefit. If confirmed, these results have im- portant public health implications for the preven- tion of cardiovascular disease.

(Am J Cardiol 1988;62:89-93)

- - .- ^~ i-rom the Center tar Research in Disease Prevention and the Divisions of General Internal Medicine and Cardiology, Stanford University School of Medicine, Stanford. California. This study was supported by Public Health Service grants HL 31 I38 and HL 24462 to Drs. Fort- mann and Wood, respectively, from the National Heart, Lung, and Blood Institute, Bethesda, Maryland. Manuscript received December 4, 1987; revised manuscript received and accepted March 18, 1988.

Address for reprints: Stephen P. Fortmann, MD, Center for Re- search in Disease Prevention, Stanford University School of Medicine, 1000 Welch Road, Palo Alto, California 94304-1885.

E levated arterial blood pressure (BP) is a significant and reversible cause of cardiovascular diseases, which continue to cause most deaths in the Unit-

ed States. The recent decline in cardiovascular disease rates is probably due in part to improved treatment of systemic hypertension,’ especially drug treatment by physicians. Pharmacologic treatment of hypertension is generally accepted by the medical profession,2 but the level of BP that requires drug therapy remains contro- versial.3m5 In addition, there are many persons with moderately increased cardiovascular risk from “high normal” BP, in whom drug therapy is not cost-effective but who nevertheless constitute a significant part of the public health impact of cardiovascular disease.6 These facts have directed considerable attention to nonphar- macologic approaches to lowering BP.4

Obesity shows a significant association in epidemio- logic studies with both BP level and cardiovascular dis- ease incidence, and there is considerable evidence that weight loss lowers BP.’ Some controversy exists over the strength of this evidence.* Well-controlled studies of the effect of increased exercise on BP, independent of weight change, are almost completely lacking.9m’ I Exer- cise and weight loss, however, have other benefits and are frequently promoted for their health effects. If they do improve BP, then the public health implications would be significant.

The study reported here took advantage of a clinical trial of the effects of weight loss on lipoproteins to ex- amine the relation of increased exercise, body fat loss and BP change. The subjects of the parent study were to be overweight and sedentary, but not hypertensive. We therefore decided to study ambulatory BP in addi- tion to the usual, clinic BP as a potentially more sensi- tive measure of small BP changes. We hypothesized that body fat loss achieved through increased caloric ex- penditure (exercise) alone would be associated with a greater decrease in average ambulatory BP than would body fat loss achieved through caloric restriction alone, because of additional effects of exercise on the cardio- vascular and neurohormonal systems. We did not ex- pect to see this effect on the usual, resting clinic BP.

METHODS Design: The parent study was designed to distin-

guish the differential effects on plasma lipoproteins of weight loss achieved by reduced caloric intake (dieting) and weight loss achieved by increased caloric expendi- ture (exercise).

THE AMERICAN JOURNAL OF CARDIOLOGY JULY 1. 1988 89

WEIGHT LOSS AND AMBULATORY BLOOD PRESSURE

Clinically healthy, sedentary, overweight, normoten- sive men were recruited via the mass media to partici- pate in a l-year weight loss trial. Following the baseline evaluation, 155 men were randomly assigned to 1 of 3 groups. The control group was to make no changes in diet, exercise or body weight. The diet group partici- pants were to attempt to lose one-third of their body fat by caloric restriction with no change in physical activity. The exercise group participants were to attempt to lose one-third of their body fat by increased caloric expendi- ture, with no change in diet. In all 3 groups, qualitative dietary composition was to remain unchanged. Weight loss in the diet and exercise groups was targeted for 9 months followed by a 3-month weight stabilization peri- od. Evaluations were repeated 12 months after baseline. The protocol was approved by the Stanford University Medical School Committee for the Protection of Hu- man Subjects before the study and annually thereafter.

Subjects: Subjects were recruited via mass media from the general public to meet the following criteria: men aged 30 to 59 years; relative weight 120 to 150% of ideal; no regular exercise for 3 months; nonsmoker; no orthopedic limitations; and willing to accept random as- signment and to participate for 1 year. After initial ex- amination, subjects further had to be clinically healthy on routine physical examination by a physician and have a resting, clinic BP <160/95 mm Hg, plasma cho- lesterol <3 15 mg/dl and plasma triglyceride <500 mg/ dl. Subjects taking medications known to affect either BP or plasma lipids were excluded.

Measurement procedures: Body weight was deter- mined with a balance scale and height with a metal cen- timeter ruler. Body composition was determined by hy- drostatic weighing using the formula of Siri.t2 Lung re- sidual volume was measured by the oxygen dilution method.t3 Dietary intake was measured using a 7-day record, which was coded and analyzed using food tables (version 10) obtained from the Nutrition Coordinating Center in Minneapolis, Minnesota.t4 A 7-day physical activity recall questionnaire was also obtained.t5

Maximal oxygen uptake was determined during a maximal treadmill exercise test, using a modified Balke protocol. Oxygen uptake was measured each minute us- ing a microcomputer-based system, with the highest val- ue obtained considered the peak or maximal value.t6 The electrocardiogram and BP were recorded at the end of each 2-minute stage of the test, at peak exercise and at 1, 3 and 6 minutes of recovery.

Resting BP was determined with the subject seated after 5 minutes of quiet rest. Brachial artery pressure was determined indirectly in the right arm using a stan- dard sphygmomanometer and stethoscope. First and fifth phase Korotkoff sounds were taken as systolic and diastolic BP, respectively. Three determinations were made and the last 2 averaged to obtain the recorded resting BP. These measurements were made before venipuncture. BP was measured the same number of times in all 3 study groups.

Ambulatory BP was determined using an automatic BP recorder model from Instruments for Cardiac Re-

90 THE AMERICAN JOURNAL OF CARDIOLOGY VOLUME 62

search. The recorder weighs 1.7 kg, measures 22 X 11 X 5 cm, and is worn at the waist. A standard BP cuff is worn on the right arm, connected to the recorder. This instrument has a programmable solid state memory and both inflates and deflates the cuff automatically. Re- cording frequency is programmed by the operator and a recording can be initiated by the subject. This instru- ment uses sound wave frequencies in the audible range to detect and record first and fifth phase Korotkoff sounds and is susceptible to error from ambient noise. This problem is minimized by instructing the subject to remain relatively still during measurements. This instru- ment has been shown to obtain readings comparable to interarterial monitoring.t7

In this study the ambulatory recorder was fitted to each patient by project staff between 7 and 8 A.M. and worn until bedtime or 11 P.M. (whichever came first). Readings were obtained automatically every 20 min- utes. Between 5 and 10% of readings were not obtain- able (the device prints an artifact code), usually because of excess ambient noise or body movement. In addition, individual pressures were excluded if the systolic BP was <50 or >260 or the diastolic BP was <30 or >150 mm Hg or if the pulse pressure was <12 or > 149 mm Hg. Overall, about 25% of readings were excluded and the mean number of acceptable readings per individual was 24 daytime and 11 evening.

Ambulatory recordings were analyzed separately for the daytime period (7 A.M. to 4:59 P.M.) and the evening period (5 to 11 P.M.). For each person, the median BP for the period was calculated to avoid giving outlying readings inappropriate weight.

Treatment program: DIET: Using the baseline 7-day diet recall, a registered dietitian provided each subject in the diet group with individual counselling on how to reduce caloric intake to achieve gradual, progressive weight loss to the goal weight after 7 months. Instruc- tions were provided so that caloric restriction would be achieved without change in nutrient composition. Sub- jects were requested to remain sedentary.

EXERCISE: Increased caloric expenditure was promot- ed in subjects assigned to the exercise group through supervised exercise training sessions and increases in routine physical activity. Each subject was scheduled for a l-hour supervised exercise session of calisthenics, walking, jogging or running 3 times a week. Exercise intensity was established at 70 to 85% of the peak heart rate reached during the baseline treadmill test. Care was taken to avoid orthopedic injuries. Subjects were also instructed to increase routine activity such as stair climbing and walking. Activity logs were kept and sub- jects were asked not to change their diet.

Compliance was enhanced in all 3 groups by sub- stantial personal attention from the staff and by foster- ing a spirit of intellectual cooperation with the investi- gators. The participants were considered “partners in research” (the motto of the study) and the need for compliance with the protocol was emphasized.

Statistical analysis: Comparisons of the baseline val- ues among groups and changes from baseline to l-year

were made by the nonparametric Wilcoxon 2-sample test. Spearman correlation coefficients were used to test associations between baseline and change variables. Standard statistical software packages were used to pro- duce both descriptive and analytic statisticsi Signifi- cance at the 5% level was accepted, using 2-tailed tests.

RESULTS Recruitment: A total of 750 persons were inter-

viewed by telephone in response to the media announce- ments. Many of these were ineligible because of age or gender, or were uninterested after additional informa- tion was given, so that only 334 were scheduled for group orientation sessions. Of these, 247 actually at- tended the orientation, during which the study was ex- plained in detail. Preliminary screening tests were per- formed on 202 subjects, after providing written consent. One hundred and fifty-five men met the criteria for en- try to the trial, and were randomized. One-hundred and fifteen men provided satisfactory data for body compo- sition, resting and ambulatory BP and dietary intake at the end of the trial, and are included in the present analysis. Loss of participants occurred equally among the control and the 2 intervention groups.

Baseline values and intervention effects: Table I lists the mean values at baseline by group for the major variables of interest. There were no significant differ- ences among the 3 groups for any of the variables listed, which includes age, body weight, body fat weight, exer- cise capacity and BP.

Table II lists the change in body weight over time for the 3 groups. The control group showed no change while the dieters, on average, achieved goal weight loss; the exercise group was intermediate. However, dieters lost lean body mass compared with control subjects while the exercisers did not. Thus, body fat loss was more comparable between the diet and exercise groups. Net body fat loss compared with control subjects was 5.2 f 0.9 kg (mean f standard error) in the diet group and 3.7 f 0.8 kg in the exercise group. This change was not significantly different between dieters and exercisers (p = 0.24). Proportional body composition (as percent body fat) also changed comparably in the 2 intervention groups, relative to control (-2.8 f 0.7% in exercisers and -3.7 f 0.9% in dieters, a diet-exercise difference of -0.9 f 0.9%, p = 0.42).

According to the 7-day diet records, daily calorie in- take decreased over the year in all 3 groups, but only the diet group changed significantly more than the con- trol group. Table II also shows this comparison and oth- er relevant dietary changes, few of which differed signif- icantly among the 3 groups. Total fat intake (g/ 1,000 kcal) decreased significantly in both dieters and exercis- ers (p <0.05), compared with control subjects, and di- etary monounsaturated fat decreased significantly in ex- ercisers. Note that the sodium estimate does not include added salt.

Maximal oxygen uptake increased significantly in the exercise group (t4.4 f 5.2 ml/kg/min, p <O.Ol compared with the control group) while decreasing

TABLE I Comparison of Major Variables at Baseline Among the Three Study Groups

Vanable’”

Age (~-1 Height (cm) Body weight (kg) Body fat weight (kg) Body fat (%) Maxrmal oxygen uptake

(ml/kg/min)

Control Group (n = 35)

45 f 7 179 f 8

95f 11 27 f 6 28 f 4 34 f 4

Diet Group Exercrse Group (n = 38) (n = 42)

44f8 44f8 177zk6 181 f 6

92 f 8 94 f 8 25 f 6 26 f 6 27 f 4 27 f 5 34 f 4 35 f 5

Blood Pressure (mm Hg)

Clrnrc Restrng SBP 120 f 9 118f9 122 f 13 Resting DBP 79 f 8 80 f 8 78 f 8

Ambulatory Daytime SBPt 126 f 10 125 f 10 128 f 10 Daytrme DBP 84 f 7 85 f 6 85 f 7 Evening SBP 123 f 11 125 f 9 126 f 10 Evening DBP 81 f 7 83 f 7 81 f 7

*No slanlflcant differences were detected amcw ~rwps for any of these

+ The group ambulatory blood pressure values are the average of the mednn blood pressures for each person during the day or evening

Data are mean f standard devlatlon DBP = dwstollc blood pressure, SBP = systolic blood pressure

TABLE II Comparison of Change in Body Mass and Dietary Intake at One Year Among the Three Study Groups

Group

Variable Control (n = 35)

Dret (n = 38)

Exercrse (n = 42)

Body werght (kg) Body fat weight (kg) Body fat (%) Calories/day

Fat (g/day) Saturated fat

(g/day) Polyunsaturated

fat (g/day) Monounsaturated

fat (g/kcal) Alcohol (g/day) Calcrum (mg/day) Potassrum (mg/day) Sodrum (mg/day)

0.5 f 3.8 -0.6 f 3.3 -0.9 f 2.9

-112 f 463 1.4 f 6.9 0.2 f 2.7

-6.9 f 4 4’ -5.8 f 4.6’ -4 6 f 4.5+

-306 f 448’ 2.0 f 7.2*

-1.0 f 3.0

-4.6 f 3.5+ -4.3 * 3.5+ -3.7 f 3.4+

-169 f 602 -2.2 f 5 5* -0.9 * 2.9

0.6 f 3.1 -0.2 + 2.3

0.5 f 2.6

-3.5 f 19 -40 f 264

-125 f 614 -101 f 1,123

-0.8 f 3.4

-48f 13 -111 l 333 -208 f 823 -148 f 856

0.0 f 2 5

-1.1 f 26’

-3.3 f 16 -25 f 316

-215 f 758 -111 f 1,083

* p < 0.05, + p < 0 01 compared wth control group Data are mea” change 3~ standard devlatlon

slightly in the other 2 groups (-0.2 f 3.5 and -2.5 f 3.4 for the diet and control groups, respectively).

In summary, the trial achieved its major goals to randomly allocate comparable groups of sedentary, overweight, middle-aged men to 3 groups, to have the control group’s mean weight, body composition, exercise and diet remain unchanged over 1 year, to have the ex- ercise group increase caloric expenditure and fitness without altering diet and to have the diet group restrict dietary calories without changing exercise level. The ex- ercise group did not achieve the desired total body fat loss, but did not lag too far behind the dieters.

Blood pressure change: Table III compares the l- year BP changes by study group, for both ambulatory

THE AMERICAN JOURNAL OF CARDIOLOGY JULY 1, 1988 91

WEIGHT LOSS AND AMBULATORY BLOOD PRESSURE

TABLE III Comparison of Change in Blood Pressure Measured at One Year Among the Three Study Groups

Variable

Clinic SBP DBP

Daytime SBP DBP

Evening spp DBP

Group Changes

Control (C) (n = 35)

-4.1 f 8.0 -2.6 f 8.1

0.2 f 7.0 1.5 f 5.4

0.6 f 7.8 1.1 f 6.3

Diet (D) Exercise (E) (n = 38) (n = 42)

-5.7 f 7.9 -6.6 f 8.4 -5.6 f 7.3 -4.1 f 8.0

-2.7 f 10.7 -2.3 f 7.1 -1.4 f 7.8 -2.0 f 5.8

-4.2 f 12.3 -3.1 f 7.9 -2.3 f 8.8 -2.0 f 7.6

Comparisons

D-C

-1.6 f 1.9 -3.0 f 1.9

-2.9 f 2.1 -2.8 f 1.6*

-4.8 f 2.4* -3.4 f 1.8

E-C

-2.5 f 1.9 -1.5 f 1.9

-2.5 f 1.6 -3.5 f 1.3’

-3.7 f 1.8’ -3.1 f 1.6*

*p<005,+p<0.01 Group changes are mean f standard devlatm: comparums of group changes are mean f standard error. DBP = dmtollc blood pressure. SBP = systok blood pressure.

and resting measurements. Clinic systolic and diastolic BP decreased between baseline and 1 year in all 3 groups without significant variation among the groups. Mean daytime and evening ambulatory systolic and dia- stolic BP decreased in both treatment groups but not in control. The magnitude of the net changes (compared with controls) was similar in both treatment groups and was between 2 and 5 mm Hg. The changes were statis- tically significant for daytime diastolic and evening sys- tolic BP in both dieters and exercisers; in addition, eve- ning diastolic BP changed significantly in exercisers, compared with control subjects. For dieters, the change in evening diastolic BP was different from control sub- jects at p = 0.07.

Because changes in nutrient intake may be associ- ated with changes in BP, we examined correlations be- tween l-year change in each of the BP variables and l- year change in dietary composition assessed from the 7- day record. Spearman’s correlation coefficients ranged from 0.01 to 0.39; most were below 0.1 and few were statistically significant. There were no convincing rela- tions between changes in nutrient intake and changes in BP in any of the 3 groups (data available from au- thors).

DISCUSSION This study demonstrates a significant decrease in

mean ambulatory BP following weight loss in 115 sed- entary, overweight, normotensive men using a random- ized control design. Weight loss achieved by reduced caloric intake or increased caloric expenditure (exer- cise) appeared to have equal effect; certainly there was no support for the hypothesis that the exercise group would show a greater BP decrease than the diet group. Clinic BP did not change significantly more in the inter- vention groups than in the control group.

The magnitude of the decrease is small, 3 to 4 mm Hg systolic and 4 to 5 mm Hg diastolic, and will seem unimportant to the clinician. However, while over- weight, these men were normotensive (mean baseline BP = 120/79 mm Hg). It is therefore inappropriate to interpret the results in a clinical setting. The public health impact of such changes is potentially large con-

92 THE AMERICAN JOURNAL OF CARDIOLOGY VOLUME 62

sidering the number of overweight persons in the US and the distinct increase in cardiovascular risk that ac- companies even small elevations of BP.6

These results do provide support, in a randomized, controlled trial using an objective measure of BP, for a causal relation between obesity and hypertension. While such a relationship has considerable support from pub- lished findings,’ many studies have design problems that limit interpretation8 The design of this study allows a strong causal inference in the group studied. It is rea- sonable to expect these results to generalize to men with higher BP, and to women, but such generalization needs to be supported by further investigation. It is appropri- ate meanwhile to use weight loss in the management of hypertension, especially for persons with mild eleva- tions, in whom the benefit to cost ratio for medications may be close to 1.

Whether or not an increase in physical activity causes a decrease in BP is controversial.g While several studies seem to show such an effect,rOJ’ others do not.19,20 Based on the results of previous research, given the normal resting BP values in our subjects, a signifi- cant reduction would not be expected. Many studies of this issue have been uncontrolled or have failed to moni- tor weight change. We postulated that the effects of ex- ercise on catecholamine response*’ would lead to a greater decrease in ambulatory BP in the exercise group than in the diet group, both of which were to lose body fat. There is no evidence in this study to support such an independent effect of exercise on BP. Again, these re- sults should be generalized to men with higher BP, and to women, with caution.

The decrease in resting clinic BP was similar for all 3 groups. The most likely explanation for this response was accommodation to the testing situation and person- nel, commonly seen for BP determinations. Accommo- dation to the ambulatory device probably occurs within the first hour or so of wearing; thus, it does not influ- ence the difference in ambulatory BP from baseline to 1 year. Also, it may be that the physiologic factor that links obesity and BP is more active during daily activi- ties than at rest and therefore would be detectable only with ambulatory monitoring.

Acknowledgment: The authors thank Darlene M. Dreon, Barbara Frey-Hewitt, Susan Garay, Marcia L. Stefanick, Richard Terry, H. Robert Superko, Paul T. Williams and the other members of the Stanford Weight Control Project Team for their assistance in planning and conducting this project. We also thank Karen Vranizan for assistance with the data analysis and Cathy Nevin for typing the manuscript.

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