Dataset Information

Cluster randomised controlled trial of home cook intervention to reduce salt intake in China: a protocol study.

ABSTRACT:

Introduction

Salt intake in China is twice the upper limit recommended by the WHO, and nearly 80% of salt is added during cooking. This study will develop a package of salt reduction interventions targeting home cooks and evaluate its effectiveness and feasibility for scale-up.

Methods and analysis

A cluster randomised controlled trial design is adopted in this study, which will be conducted in six provinces covering northern, central and southern China. For each province, 10 communities/villages (clusters) with 13 families (one cook and one adult family member) will be selected in each cluster for evaluation. In total, 780 home cooks and 780 adult family members will be recruited. The home cooks in the intervention group will be provided with the intervention package, including community-based standardised offline and online health education and salt intake monitoring. The duration of the intervention will be 1?year. The primary outcome is the difference between the intervention and control group in change in salt intake as measured by 24?hours urinary sodium from baseline to the end of the trial. The secondary outcome is the difference between the two groups in the change in salt-related knowledge, attitude and practice and blood pressure (BP).

Ethics and dissemination

The study has been approved by The Queen Mary Research Ethics Committee (QMERC2018/13) and Institutional Review Board of the Chinese Center for Disease Control and Prevention (No. 201801). The study findings will be disseminated widely through conference presentations and peer-reviewed publications and the general media.

Trial registration number

ChiCTR1800016804.

SUBMITTER: Zhang X

PROVIDER: S-EPMC7228508 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Publications

Cluster randomised controlled trial of home cook intervention to reduce salt intake in China: a protocol study.

Zhang Xiaochang X Hu Xiao X Ma Jixiang J Zhang Puhong P Li Yuan Y Luo Rong R He Feng J FJ MacGregor Graham A GA Wang Jinglei J Yin Zhaoxue Z

BMJ open 20200507 5

<h4>Introduction</h4>Salt intake in China is twice the upper limit recommended by the WHO, and nearly 80% of salt is added during cooking. This study will develop a package of salt reduction interventions targeting home cooks and evaluate its effectiveness and feasibility for scale-up.<h4>Methods and analysis</h4>A cluster randomised controlled trial design is adopted in this study, which will be conducted in six provinces covering northern, central and southern China. For each province, 10 comm ...[more]

PMID: 32385058

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Project description:IntroductionSalt intake in China (≈12 g/day) is more than twice the upper limit recommended by the WHO (5 g/day). To reduce salt intake, Action on Salt China (ASC) was launched in 2017. As one of four randomised controlled trials (RCTs) in the ASC programme, a comprehensive intervention study was designed to test whether all the components of the interventions adopted by other RCTs are acceptable, scalable and effective when provided to a region in the real world.Methods and analysisUsing a cluster RCT design, 2688 participants were selected from 48 towns (clusters) in 12 counties in 6 provinces and assigned to the intervention group or the control group. Randomisation was performed after the baseline survey was completed. Information on salt-related knowledge, attitude and practice (KAP), blood pressure and 24-hour urinary sodium were collected. The intervention includes government engagement, health education and other intervention components targeting restaurants, home cooks and primary school students and their families that have been used in other RCTs. The control group will not receive the intervention. The project will be followed up for 2 years, with the intervention being carried out for the first year only. The primary outcome is salt intake measured by 24-hour urinary sodium excretion after 1 year. The secondary outcomes are the long-lasting effectiveness on salt intake and blood pressure measured by the same method, as well as salt-related KAP and blood pressure at the 1-year and 2-year follow-ups. Process evaluation and health economics analysis will be conducted as well.Ethics and disseminationThe study was reviewed and approved by the Institutional Review Board of the National Center for Chronic and Noncommunicable Disease Control and Prevention, the Chinese Center for Disease Control and Prevention, and Queen Mary Research Ethics Committee. Results will be disseminated through presentations, publications and social media.Trial registration numberChiCTR1800018119.

Project description:ObjectiveTo determine whether a smartphone application based education programme can lower salt intake in schoolchildren and their families.DesignParallel, cluster randomised controlled trial, with schools randomly assigned to either intervention or control group (1:1).Setting54 primary schools from three provinces in northern, central, and southern China, from 15 September 2018 to 27 December 2019.Participants592 children (308 (52.0%) boys; mean age 8.58 (standard deviation 0.41) years) in grade 3 of primary school (about 11 children per school) and 1184 adult family members (551 (46.5%) men; mean age 45.80 (12.87) years).InterventionChildren in the intervention group were taught, with support of the app, about salt reduction and assigned homework to encourage their families to participate in activities to reduce salt consumption.Main outcome measuresPrimary outcome was the difference in salt intake change (measured by 24 hour urinary sodium excretion) at 12 month follow-up, between the intervention and control groups.ResultsAfter baseline assessment, 297 children and 594 adult family members (from 27 schools) were allocated to the intervention group, and 295 children and 590 adult family members (from 27 schools) were allocated to the control group. During the trial, 27 (4.6%) children and 112 (9.5%) adults were lost to follow-up, owing to children having moved to another school or adults unable to attend follow-up assessments. The remaining 287 children and 546 adults (from 27 schools) in the intervention group and 278 children and 526 adults (from 27 schools) in the control group completed the 12 month follow-up assessment. Mean salt intake at baseline was 5.5 g/day (standard deviation 1.9) in children and 10.0 g/day (3.5) in adults in the intervention group, and 5.6 g/day (2.1) in children and 10.0 g/day (3.6) in adults in the control group. During the study, salt intake of the children increased in both intervention and control groups but to a lesser extent in the intervention group (mean effect of intervention after adjusting for confounding factors -0.25 g/day, 95% confidence interval -0.61 to 0.12, P=0.18). In adults, salt intake decreased in both intervention and control groups but to a greater extent in the intervention group (mean effect -0.82 g/day, -1.24 to -0.40, P<0.001). The mean effect on systolic blood pressure was -0.76 mm Hg (-2.37 to 0.86, P=0.36) in children and -1.64 mm Hg (-3.01 to -0.27, P=0.02) in adults.ConclusionsThe app based education programme delivered through primary school, using a child-to-parent approach, was effective in lowering salt intake and systolic blood pressure in adults, but the effects were not significant in children. Although this novel approach could potentially be scaled up to larger populations, the programme needs further strengthening to reduce salt intake across the whole population, including schoolchildren.Trial registrationChinese Clinical Trial Registry ChiCTR1800017553.

Project description:IntroductionUp to 80% of patients with respiratory tract infections (RTI) attending healthcare facilities in rural areas of China are prescribed antibiotics, many of which are unnecessary. Since 2009, China has implemented several policies to try to reduce inappropriate antibiotic use; however, antibiotic prescribing remains high in rural health facilities.Methods and analysisA cluster randomised controlled trial will be carried out to estimate the effectiveness and cost effectiveness of a complex intervention in reducing antibiotic prescribing at township health centres in Anhui Province, China. 40 Township health centres will be randomised at a 1:1 ratio to the intervention or usual care arms. In the intervention group, practitioners will receive an intervention comprising: (1) training to support appropriate antibiotic prescribing for RTI, (2) a computer-based treatment decision support system, (3) virtual peer support, (4) a leaflet for patients and (5) a letter of commitment to optimise antibiotic use to display in their clinic. The primary outcome is the percentage of antibiotics (intravenous and oral) prescribed for RTI patients. Secondary outcomes include patient symptom severity and duration, recovery status, satisfaction, antibiotic consumption. A full economic evaluation will be conducted within the trial period. Costs and savings for both clinics and patients will be considered and quality of life will be measured by EuroQoL (EQ-5D-5L). A qualitative process evaluation will explore practitioner and patient views and experiences of trial processes, intervention fidelity and acceptability, and barriers and facilitators to implementation.Ethics and disseminationEthical approval was obtained from the Biomedical Research Ethics Committee of Anhui Medical University (Ref: 20180259); the study has undergone due diligence checks and is registered at the University of Bristol (Ref: 2020-3137). Research findings will be disseminated to stakeholders through conferences and peer-reviewed journals in China, the UK and internationally.Trial registration numberISRCTN30652037.

Project description:ObjectiveTo determine whether an education programme targeted at schoolchildren could lower salt intake in children and their families.DesignCluster randomised controlled trial, with schools randomly assigned to either the intervention or control group.Setting28 primary schools in urban Changzhi, northern China.Participants279 children in grade 5 of primary school, with mean age of 10.1; 553 adult family members (mean age 43.8).InterventionChildren in the intervention group were educated on the harmful effects of salt and how to reduce salt intake within the schools' usual health education lessons. Children then delivered the salt reduction message to their families. The intervention lasted for one school term (about 3.5 months).Main outcome measuresThe primary outcome was the difference between the groups in the change in salt intake (as measured by 24 hour urinary sodium excretion) from baseline to the end of the trial. The secondary outcome was the difference between the two groups in the change in blood pressure.ResultsAt baseline, the mean salt intake in children was 7.3 (SE 0.3) g/day in the intervention group and 6.8 (SE 0.3) g/day in the control group. In adult family members the salt intakes were 12.6 (SE 0.4) and 11.3 (SE 0.4) g/day, respectively. During the study there was a reduction in salt intake in the intervention group, whereas in the control group salt intake increased. The mean effect on salt intake for intervention versus control group was -1.9 g/day (95% confidence interval -2.6 to -1.3 g/day; P<0.001) in children and -2.9 g/day (-3.7 to -2.2 g/day; P<0.001) in adults. The mean effect on systolic blood pressure was -0.8 mm Hg (-3.0 to 1.5 mm Hg; P=0.51) in children and -2.3 mm Hg (-4.5 to -0.04 mm Hg; P<0.05) in adults.ConclusionsAn education programme delivered to primary school children as part of the usual curriculum is effective in lowering salt intake in children and their families. This offers a novel and important approach to reducing salt intake in a population in which most of the salt in the diet is added by consumers.Trial registration ClinicalTrials.gov NCT01821144. .

Dataset Information

Cluster randomised controlled trial of home cook intervention to reduce salt intake in China: a protocol study.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Cluster randomised controlled trial of home cook intervention to reduce salt intake in China: a protocol study.

Similar Datasets

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