TOHP, I Unclear risk Low risk Participants: <5% loss to Yes (low risk) No (low risk) Yes (low National Heart, (method of (Concealment of unclear risk follow-up (low risk) Lung, and Blood -Whelton et al. randomisation allocation at a risk) Institute, (1992) Providers: not described) central location) National high risk Institutes of Kumanyika et Health (low risk) al. (1993) Outcome assessors: low -Whelton et al. risk (1997a) Summary table Citation Population Intervention Outcomes Sample Compliance to Results & design level measured size sodium target location of relevant to duration (urinary data) research question TOHP, II Moderately Participants were randomly BP (seated) 1190 36 48 Mean difference Mean difference – (note DBP Phase II overweight assigned to one of four months in the change in between sodium was primary parallel adults (30 54 treatment groups: urinary sodium reduction and – outcome, -Whelton design years), with high excretion control period: SBP et al. 1. weight loss (goal normal diastolic between groups secondary (1997b) achievement of desirable SBP: (SEM: blood pressure (active control): outcome) – body weight or mean 0.52, CI: -2.02, 0.02) (mean USA weight loss of at least -40.4 + 5.7 DBP:86.1mmHg DBP: -0.5mmHg 4.5kg) (group and (p<0.001) [] in sodium (SEM: 0.4, CI: -1.28, individual education) reduction group 0.28)
TOHP, I -Whelton et al. (1992) Kumanyika et al. (1993) -Whelton et al. (1997a) Unclear risk (method of randomisation not described) Low risk (Concealment of allocation at a central location) Participants: unclear risk Providers: high risk Outcome assessors: low risk <5% loss to follow-up (low risk) Yes (low risk) No (low risk) Yes (low risk) National Heart, Lung, and Blood Institute, National Institutes of Health (low risk) Summary table Citation & location design level of Population Intervention Outcomes measured relevant to research question Sample size duration Compliance to sodium target (urinary data) Results TOHP, Phase II -Whelton et al. (1997b) USA [] parallel design II Moderately overweight adults (30 – 54 years), with high normal diastolic blood pressure (mean DBP:86.1mmHg in sodium reduction group Participants were randomly assigned to one of four treatment groups: 1. weight loss (goal achievement of desirable body weight or mean weight loss of at least 4.5kg) (group and individual education) BP (seated) (note DBP was primary outcome, SBP secondary outcome) 1190 36 – 48 months Mean difference in the change in urinary sodium excretion between groups (active – control): -40.4 + 5.7 (p<0.001) Mean difference between sodium reduction and control period: SBP: (SEM: 0.52, CI: -2.02, 0.02) DBP: -0.5mmHg (SEM: 0.4, CI: -1.28, 0.28)
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