Summary table Citation Study Population Intervention Outcomes Sample Compliance to Results & design level measured size sodium target location of relevant to duration (urinary data) research question TOHP, II Adults (30 54 Participants were randomly BP (seated 744 (in 18 Mean difference Mean – 5 min Phase I years), with high assigned to either lifestyle (18 sodium months in the change in difference rest) (note parallel normal diastolic months) or supplement reduction urinary sodium between DBP was -Whelton design blood pressure interventions (6 months each, and excretion sodium primary et al. study (mean: compared with placebo): control between groups reduction and outcome, (1992) groups, (active control period: SBP – Lifestyle 1: weight reduction in sodium n=2182 control): secondary (group and individual education) SBP: outcome) reduction group for total et al. -43.86 (CI: and study) (1993) Lifestyle 2: sodium reduction -30.84) (SEM: 0.59, CI: (group and individual education) mmol/24hr -2.86, -0.54) -Whelton in control) (p<0.01) et al. Lifestyle 3: stress management DBP: (1997a) (group and individual education) (SEM: 0.42, CI: USA Lifestyle 4: usual care -1.62, 0.02) [, , ] Supplement 1: calcium Supplement 2: magnesium Supplement 3: fish oil Supplement 4: potassium
Summary table Citation & location Study design level of Population Intervention Outcomes measured relevant to research question Sample size duration Compliance to sodium target (urinary data) Results TOHP, Phase I -Whelton et al. (1992) et al. (1993) -Whelton et al. (1997a) USA [, , ] parallel design study II Adults (30 – 54 years), with high normal diastolic blood pressure (mean: in sodium reduction group and in control) Participants were randomly assigned to either lifestyle (18 months) or supplement interventions (6 months each, compared with placebo): Lifestyle 1: weight reduction (group and individual education) Lifestyle 2: sodium reduction (group and individual education) Lifestyle 3: stress management (group and individual education) Lifestyle 4: usual care Supplement 1: calcium Supplement 2: magnesium Supplement 3: fish oil Supplement 4: potassium BP (seated 5 min rest) (note DBP was primary outcome, SBP secondary outcome) 744 (in sodium reduction and control groups, n=2182 for total study) 18 months Mean difference in the change in urinary sodium excretion between groups (active – control): -43.86 (CI: -30.84) mmol/24hr (p<0.01) Mean difference between sodium reduction and control period: SBP: (SEM: 0.59, CI: -2.86, -0.54) DBP: (SEM: 0.42, CI: -1.62, 0.02)
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