Background: Despite the reported benefits, weight loss is not always advised for older adults because some observational studies have associated weight loss with increased mortality. However, the distinction between intentional and unintentional weight loss is difficult to make in an observational context, so the effect of intentional weight loss on mortality may be clarified in the setting of a randomized controlled trial.
Objective: The objective was to determine the effect of intentional weight loss on all-cause mortality by using follow-up data from a randomized trial completed in 1995 that included a weight-loss arm.
Design: The Trial of Nonpharmacologic Intervention in the Elderly (TONE) used a 2 × 2 factorial design to determine the effect of dietary weight loss, sodium restriction, or both on blood pressure control in 585 overweight or obese older adults being treated for hypertension (mean ± SD age: 66 ± 4 y; 53% female). All-cause mortality was ascertained by using the Social Security Index and National Death Index through 2006.
Results: The mortality rate of those who were randomly assigned to the weight-loss intervention (n = 291; mean weight loss: 4.4 kg) did not differ significantly from that of those who were not randomly assigned to this group (n = 294; mean weight loss: 0.8 kg). The adjusted HR was 0.82 (95% CI: 0.55, 1.22).
Conclusions: Intentional dietary weight loss was not significantly associated with increased all-cause mortality over 12 y of follow-up in older overweight or obese adults. Additional studies are needed to confirm and extend our findings to older age groups. This trial is registered at clinicaltrials.gov as NCT00000535.