A Randomized Trial of a Low-Fat Diet Intervention on Blood Pressure and Hypertension: Tertiary Analysis of the WHI Dietary Modification Trial

Abstract

Background: This post hoc analysis determined if the Women's Health Initiative (WHI) Diet Modification intervention (DM-I) resulted in a significantly different rate of incident hypertension (HTN), as well as longitudinal changes in blood pressure.

Methods: Participants were 48,835 postmenopausal women aged 50-79 years who were randomly assigned to either the intervention or comparison group. HTN was defined as self-report of treated HTN collected semiannually or blood pressure ≥140/90mm Hg at one of the annual follow-up clinic visits.

Results: After a mean follow-up of 8.3 years, and among those who did not have HTN at baseline (n = 31,146), there were 16,174 (51.9%) HTN cases and those assigned to the intervention group had a 4% lower overall risk of developing incident HTN (hazard ratio (HR): 0.96, 95% confidence interval (CI): 0.93-0.99). Although the risk of HTN was lower in the DM-I group in the first few years, the HR became greater than 1 after year 5 (P-trend < 0.01). Similarly, randomization to the DM-I arm resulted in a small but significantly lower average systolic blood pressure (SBP) at 1 year of follow-up (-0.66mm Hg, 0.44-0.89) that increased over the following 8 years (0.16mm Hg/year, 0.11-0.21), such that any early benefit was eliminated by year 5 and a minimal deleterious effect emerged by year 7.

Conclusion: Randomization to an intensive behavioral dietary modification program aimed at a lower total fat intake is not associated with sustained reductions in blood pressure or risk of HTN in postmenopausal women.

Clinical trial registration: url http://www.clinicaltrials.gov, unique identifier nct00000611.

Trial registration: ClinicalTrials.gov NCT00000611.

Keywords: blood pressure; diet; hypertension; trial; women..