Journal Design Clinical Emerald
African Food Systems Research (Interdisciplinary - incl Agri/Env) | 07 October 2019

Protocol for a Randomised Controlled Trial of a Mobile Health Behavioural Nudge Intervention to Reduce Dietary Sodium in Hypertensive Adults in Khayelitsha, South Africa

L, u, n, g, i, l, e, v, a, n, d, e, r, M, e, r, w, e, ,, T, h, a, n, d, i, w, e, N, k, o, s, i
mHealthSodium ReductionRandomised Controlled TrialSub-Saharan Africa
Protocol for a two-arm RCT testing mHealth nudges against usual care in 300 hypertensive adults.
Primary outcome: change in 24-hour urinary sodium excretion after 12 weeks.
Intervention uses daily SMS and weekly interactive voice messages to promote salt reduction.
Analysis employs a linear mixed-effects model with intention-to-treat principles.

Abstract

{ "background": "Excessive dietary sodium is a major modifiable risk factor for hypertension, a leading cause of morbidity and mortality in South Africa. Urban township populations face specific environmental and socioeconomic barriers to reducing salt intake. Mobile health (mHealth) interventions using behavioural nudges offer a scalable, low-cost strategy, but their effectiveness in this context requires robust evaluation.", "purpose and objectives": "This protocol describes a randomised controlled trial to assess the effectiveness of a mobile phone-based behavioural nudge intervention, compared to usual care, in reducing dietary sodium intake among hypertensive adults in Khayelitsha. The primary objective is to determine the intervention's effect on 24-hour urinary sodium excretion. Secondary objectives include effects on blood pressure, dietary knowledge, and salt-related behaviours.", "methodology": "A two-arm, single-blind, parallel-group RCT will enrol 300 hypertensive adults. Participants will be randomised (1:1) to receive either a 12-week mHealth intervention (daily SMS nudges and weekly interactive voice messages promoting salt reduction) or usual care. The primary outcome is change in 24-hour urinary sodium excretion from baseline to 12 weeks. Secondary outcomes include office and home blood pressure measurements and questionnaire-assessed behaviours. Analysis will use an intention-to-treat approach. The primary analysis will employ a linear mixed-effects model: $Y{ij} = \\beta0 + \\beta1 Ti + \\beta2 Bi + uj + \\epsilon{ij}$, where $Y{ij}$ is the sodium excretion for participant $i$ at follow-up $j$, $Ti$ is the treatment indicator, $Bi$ is the baseline measurement, $uj$ is the random intercept, and $\\epsilon_{ij}$ is the error term. The treatment effect will be reported with a 95% confidence interval.", "findings": "As this is a protocol for a future study, no empirical findings are available. The anticipated primary result is a reduction in mean 24-hour urinary sodium excretion of