OBJECTIVE: To compare weight loss in blacks and whites in the Trial of Nonpharmacologic Interventions in the Elderly (TONE).
RESEARCH METHODS AND PROCEDURES: TONE enrolled 421 overweight white and 164 overweight black adults, 60 to 79 years old, with blood pressure well-controlled on a single, antihypertensive drug. Drug therapy withdrawal was attempted 3 months after randomization to counseling for weight loss, sodium reduction, both weight loss and sodium reduction, or to usual care, with follow-up for 15 to 36 months after enrollment. Statistical procedures included repeated measures analysis of covariance and logistic and proportional hazards regression.
RESULTS: In the weight-loss condition, net weight change (in kilograms) was -2.7 in blacks and -5.9 in whites (p < 0.001; ethnic difference, p = 0.0002) at 6 months and -2.0 (p < 0.05) in blacks and -4.9 (p < 0.001) in whites at the end of follow-up (ethnic difference, p = 0.007). In weight/sodium, net weight change was -2.1 (p < 0.01) in blacks and -2.8 (p < 0.001) in whites at 6 months, and -1.9 in blacks and -1.7 in whites at the end of follow-up (p < 0.05; ethnic difference, p > 0.5). Exploratory analyses suggested a more favorable pattern of weight change in blacks than in whites from 6 months onward. There was no ethnic difference in blood pressure outcomes.
DISCUSSION: Whites lost more weight than blacks without, but not with, a concurrent focus on sodium reduction.
BACKGROUND: Weight loss and sodium reduction programs are effective in treating hypertension, but there is little information about the persistence of the benefit after discontinuation of the intervention.
METHODS: The Trial of Nonpharmacologic Interventions in the Elderly (TONE) was a four-center controlled clinical trial of weight loss, reduced sodium intake, or both in maintaining normotension after withdrawal of antihypertensive drug therapy in older men and women whose hypertension was controlled with a single antihypertensive medication. Information on maintenance of normotension without need for drug therapy was obtained on 222 of 223 participants at the Robert Wood Johnson Medical School clinical center on average of 48.4 months (range 45 to 54 months) after the end of TONE.
RESULTS: At the end of TONE follow-up, 43% of participants in the combined intervention group were off medication compared with 25% in the usual care group (P = .011). At 48 months after the end of TONE and discontinuation of contact of the participants with the clinical center, 23% of the combined intervention group v 7% in the usual care group were off medication (P = .012).
CONCLUSIONS: Some benefits of structured dietary intervention appears to persist long term in a significant number of patients after discontinuation of the intervention.
BACKGROUND: National guidelines recommend consideration of step down or withdrawal of medication in patients with well-controlled hypertension, but knowledge of factors that predict or mediate success in achieving this goal is limited. OBJECTIVE: To identify patient characteristics associated with success in controlling blood pressure (BP) after withdrawal of antihypertensive medication. DESIGN: The Trial of Nonpharmacologic Interventions in the Elderly tested whether lifestyle interventions designed to promote weight loss or a reduced intake of sodium, alone or in combination, provided satisfactory BP control among elderly patients (aged 60-80 years) with hypertension after withdrawal from antihypertensive drug therapy. Participants were observed for 15 to 36 months after attempted drug withdrawal. MAIN OUTCOME MEASURES: Trial end points were defined by (1) a sustained BP of 150/90 mm Hg or higher, (2) a clinical cardiovascular event, or (3) a decision by participants or their personal physicians to resume BP medication. RESULTS: Proportional hazards regression analyses indicated that the hazard (+/- SE) of experiencing an end point among persons assigned to active interventions was 75% +/- 9% (weight loss), 68% +/- 7% (sodium reduction), and 55% +/- 7% (combined weight loss/sodium reduction) that of the hazard for those assigned to usual care. Lower baseline systolic BP (P < .001), fewer years since diagnosis of hypertension (P < .001), fewer years of antihypertensive treatment (P < .001), and no history of cardiovascular disease (P = .01) were important predictors of maintaining successful nonpharmacological BP control throughout follow-up, based on logistic regression analysis. Age, ethnicity, baseline level of physical activity baseline weight, medication class, smoking status, and alcohol intake were not statistically significant predictors. During follow-up, the extent of weight loss (P = .001) and urinary sodium excretion (P = .04) were associated with a reduction in the risk of trial end points in a graded fashion. CONCLUSIONS: Withdrawal from antihypertensive medication is most likely to be successful in patients with well-controlled hypertension who have been recently (within 5 years) diagnosed or treated, and who adhere to life-style interventions involving weight loss and sodium reduction. More than 80% of these patients may have success in medication withdrawal for longer than 1 year.
CONTEXT: Nonpharmacologic interventions are frequently recommended for treatment of hypertension in the elderly, but there is a paucity of evidence from randomized controlled trials in support of this recommendation. OBJECTIVE: To determine whether weight loss or reduced sodium intake is effective in the treatment of older persons with hypertension. DESIGN: Randomized controlled trial. PARTICIPANTS: A total of 975 [corrected] men and women aged 60 to 80 years with systolic blood pressure lower than 145 mm Hg and diastolic blood pressure lower than 85 mm Hg while receiving treatment with a single antihypertensive medication. SETTING: Four academic health centers. INTERVENTION: The 585 obese participants were randomized to reduced sodium intake, weight loss, both, or usual care, and the 390 nonobese participants were randomized to reduced sodium intake or usual care. Withdrawal of antihypertensive medication was attempted after 3 months of intervention. MAIN OUTCOME MEASURE: Diagnosis of high blood pressure at 1 or more follow-up visits, or treatment with antihypertensive medication, or a cardiovascular event during follow-up (range, 15-36 months; median, 29 months). RESULTS: The combined outcome measure was less frequent among those assigned vs not assigned to reduced sodium intake (relative hazard ratio, 0.69; 95% confidence interval [CI], 0.59-0.81; P<.001) and, in obese participants, among those assigned vs not assigned to weight loss (relative hazard ratio, 0.70; 95% CI, 0.57-0.87; P<.001). Relative to usual care, hazard ratios among the obese participants were 0.60 (95% CI, 0.45-0.80; P<.001) for reduced sodium intake alone, 0.64 (95% CI, 0.49-0.85; P=.002) for weight loss alone, and 0.47 (95% CI, 0.35-0.64; P<.001) for reduced sodium intake and weight loss combined. The frequency of cardiovascular events during follow-up was similar in each of the 6 treatment groups. CONCLUSION: Reduced sodium intake and weight loss constitute a feasible, effective, and safe nonpharmacologic therapy of hypertension in older persons.
OBJECTIVE: To compare and assess the single and joint effect of diet and exercise intervention for 1 year on insulin resistance and the development leading toward the insulin resistance syndrome. RESEARCH DESIGN AND METHODS: An unmasked, randomized 2 x 2 factorial intervention trial was applied with a duration of 1 year for each participant. The trial comprised 219 men and women with diastolic blood pressure of 86-99 mmHg, HDL cholesterol < 1.20 mmol/l, triglycerides > 1.4 mmol/l, total cholesterol of 5.20-7.74 mmol/l, and BMI > 24 kg/m2. Participants were randomly allocated to diet group (n = 35), diet and exercise group (n = 67), exercise group (n = 54), and control group (n = 43). The diet included increased intake of fish and reduced total fat intake. The exercise program entailed supervised endurance exercise three times a week. Baseline cross-sectional changes and 1-year changes in insulin resistance, fasting serum levels of insulin, C-peptide, proinsulin, glucose, and lipids as well as weight, mean blood pressure, and plasminogen activator inhibitor 1 (PAI-1) values were recorded. RESULTS: The cross-sectional results at baseline showed significant correlations between the calculated insulin resistance and BMI (r = 0.54) and correlations between the mean blood pressure (mBP) (r = 0.26) and PAI-1 (r = 0.40). The 1-year diet intervention gave a significant decrease in the calculated insulin resistance from 4.6 to 4.2 and a positive correlation between the changes in insulin resistance and changes in BMI (r = 0.40). The diet and exercise intervention also led to significantly decreased insulin resistance (from 5.0 to 4.0). The exercise intervention did not significantly change insulin resistance. CONCLUSIONS: The cross-sectional and 1-year intervention results supported each other and underscored the important connection between increased BMI and the development leading toward the insulin resistance syndrome.
OBJECTIVES: To compare the single and joint effect of 1-year diet and exercise intervention on carbohydrate metabolism and associated coronary risk variables. DESIGN: Unmasked, randomized, 2 x 2 factorial intervention trial with 1-year duration for each participant. SETTING: The participants were recruited from a screening examination of 40-year-old persons in Oslo, Norway. SUBJECTS: Two hundred and nineteen sedentary men and women, with diastolic blood pressure 86-99 mmHg, HDL cholesterol < 1.20 mmol L-1, triglycerides > 1.4 mmol L-1, total cholesterol 5.20-7.74 mmol L-1 and BMI > 24. Participants were randomly allocated to control (n = 43), diet (n = 55), exercise (n = 54) and diet+exercise (n = 67). INTERVENTIONS: Exercise: supervised endurance exercise three times a week. Diet: reduce weight, increase the intake of fish and reduce total fat intake. MAIN OUTCOME MEASURES: One-year changes in insulin and glucose before and after a standardized glucose load. RESULTS: As compared with controls fasting insulin in pmol L-1 decreased significantly in the combined diet and exercise group (3.9 +/- 6.2 versus -22.6 +/- 4.7 respectively, P = 0.003). Insulin in pmol L-1 after glucose load decreased significantly in all intervention groups compared to controls (diet: -82.2 +/- 49.9 P = 0.02; exercise: -92.4 +/- 60.1 P = 0.03; diet + exercise: -179.6 +/- 46.1 P = 0.0004). Fasting glucose in mmol L-1 decreased significantly in the diet alone group (0.21 +/- 0.07 P = 0.006) and in the diet+exercise group (-0.26 +/- 0.08 P = 0.005). In a subgroup analysis of the good responders, the observed changes with respect to total cholesterol (-0.76 mmol L-1), HDL cholesterol (0.16 mmol L-1), triglycerides (-0.72 mmol L-1), systolic and diastolic blood pressure (-8.5/ -6.8 mmHg) were all statistically significant compared to the control with P < 0.001). CONCLUSIONS: Exercise and diet intervention and in particular the combination of the two, were effective in improving carbohydrate metabolism. Associated risk factors were also affected in a beneficial direction.
National and international policy-making organizations advocate nonpharmacologic therapies to reduce blood pressure (BP). However, data to support such recommendations in older persons are virtually nonexistent. The Trials of Nonpharmacologic Intervention in the Elderly (TONE) is a randomized, controlled trial that will test whether weight loss or a reduced sodium (Na) intake or both can maintain satisfactory BP control, without unacceptable side effects, after withdrawal of antihypertensive drug therapy. Medication-treated hypertensives (aged 60 to 80 years) with a systolic BP less than 145 mm Hg and a diastolic BP less than 85 mm Hg who are taking one antihypertensive medication are randomly assigned to one of four groups: (1) weight loss alone, (2) reduced Na intake alone, (3) combined weight loss and reduced Na intake, or (4) usual life-style (control group). Overweight participants are randomized to one of these four groups, while nonoverweight individuals are assigned to either the reduced Na intake or the usual life-style group. The interventions, tailored to the needs of older persons, use behavioral approaches to accomplish intervention-specific goals (weight loss > or = 10 lb, daily Na intake < or = 80 mEqa). Three months after the start of intervention, antihypertensive drug therapy is withdrawn. The primary trial end point is a BP of 150/90 mm Hg or higher, resumption of antihypertensive drug therapy, or the occurrence of a BP-related clinical complication during 2 to 3 years of follow-up. It is anticipated that TONE findings may identify an effective and acceptable nonpharmacologic approach to control hypertension in the increasingly large number of older persons treated with antihypertensive drug therapy.
