The Trial of Nonpharmacologic Interventions in the Elderly (TONE) was a randomized, controlled clinical trial designed to test the effectiveness of three lifestyle interventions in controlling blood pressure in 60- to 80- year-old men and women. The three interventions-sodium reduction alone, weight loss alone, and combined weight loss/sodium reduction-were compared to a usual-care control group. A total of 975 medication-treated hypertensives were enrolled in the trial. Almost half (N = 467; 48%) were female; 234 (24%) were from a minority background, predominantly African-American. The average systolic blood pressure (SBP) and diastolic blood pressure (DBP) at entry were 128 mmHg and 72 mmHg, respectively. The average body mass index was 28.8 kg/m2, and the mean waist-to-hip ratio was 0.94. Mean sodium excretion based on timed 24-hr urine collections was 129.9 mmol/24 hr in women and 165.5 mmol/24 hr in men. There were no substantial differences in the distribution of baseline characteristics across the four randomized groups; however, among obese participants, there were small but significant differences in mean pulse rate (range: 70.1-72.8 beats/min, p = 0.01) and mean total kilocalories (range, 1708-1870, p = 0.05). Given the large number of measurements collected before randomization, it is likely that these differences may be due to chance. Overall, the comparability of the four randomized groups at baseline confirms the success of randomization and suggests that any subsequent difference in blood pressure control is unlikely to result from maldistribution of known confounders at baseline. Finally, several aspects of the TONE study population (e.g., the large number of women and minorities, its high body weight and sodium intake) enhance the generalizability of trial results. The substantial number of women and African-Americans enrolled allowed for extended subgroup analyses.
ASJC Scopus subject areas
- Medicine (miscellaneous)