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A town level comprehensive intervention study to reduce salt intake in China: protocol for a cluster randomised controlled trial.

ABSTRACT: INTRODUCTION:Salt 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 ANALYSIS:Using 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 DISSEMINATION:The 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 NUMBER:ChiCTR1800018119.

SUBMITTER: Xu J

PROVIDER: S-EPMC6955555 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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A town level comprehensive intervention study to reduce salt intake in China: protocol for a cluster randomised controlled trial.

Xu Jianwei J Tang Biwei B Liu Min M Bai Yamin Y Yan Wei W Zhou Xue X Xu Zhihua Z He Jun J Jin Donghui D Sun Jixin J Li Yuan Y He Feng J FJ MacGregor Graham A GA Wu Jing J Zhang Puhong P

BMJ open 20200109 1

<h4>Introduction</h4>Salt 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.<h4>Methods and analysi ...[more]

PMID: 31924637

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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: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. .

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:BackgroundMen's perpetration of intimate partner violence (IPV) limits gains in health and wellbeing for populations globally. Largely informal, rapidly expanding peri-urban settlements, with limited basic services such as electricity, have high prevalence rates of IPV. Evidence on how to reduce men's perpetration, change social norms and patriarchal attitudes within these settings is limited. Our cluster randomised controlled trial aimed to determine the effectiveness of the Sonke CHANGE intervention in reducing use of sexual and/or physical IPV and severity of perpetration by men aged 18-40 years over 2 years.MethodologyThe theory-based intervention delivered activities to bolster community action, including door-to-door discussions, workshops, drawing on the CHANGE curriculum, and deploying community action teams over 18 months. In 2016 and 2018, we collected data from a cohort of men, recruited from 18 clusters; nine were randomised to receive the intervention, while the nine control clusters received no intervention. A self-administered questionnaire, using audio-computer assisted software, asked about sociodemographics, gender attitudes, mental health, and the use and severity of IPV. We conducted an intention-to-treat analysis at the cluster level comparing the expected risk to observed risk of using IPV while controlling for baseline characteristics. A secondary analysis used latent classes (LCA) of men to see whether there were differential effects of the intervention for subgroups of men.ResultsOf 2406 men recruited, 1458 (63%) were followed to 2 years. Overall, we saw a reduction in men's reports of physical, sexual and severe IPV from baseline to endpoint (40.2% to 25.4%, 31.8% to 15.8%, and 33.4% to 18.2%, respectively). Intention-to-treat analysis showed no measurable differences between intervention and control clusters for primary IPV outcomes. Difference in the cluster-level proportion of physical IPV perpetration was 0.002 (95% confidence interval [CI] - 0.07 to 0.08). Similarly, differences between arms for sexual IPV was 0.01 (95% CI - 0.04 to 0.06), while severe IPV followed a similar pattern (Diff = 0.01; 95% CI - 0.05 to 0.07). A secondary analysis using LCA suggests that among the men living in intervention communities, there was a greater reduction in IPV among less violent and more law abiding men than among more highly violent men, although the differences did not reach statistical significance.ConclusionThe intervention, when implemented in a peri-urban settlement, had limited effect in reducing IPV perpetrated by male residents. Further analysis showed it was unable to transform entrenched gender attitudes and use of IPV by those men who use the most violence, but the intervention showed promise for men who use violence less.Trial registrationClinicalTrials.gov, NCT02823288. Registered on 30 June 2016.

Project description:Introduction Excessive alcohol consumption is responsible for considerable harm from chronic disease and injury. Within most developed countries, members of sporting clubs consume alcohol at levels above that of communities generally. Despite the potential benefits of interventions to address alcohol consumption in sporting clubs, there have been no randomised controlled trials to test the effectiveness of these interventions. The aim of this study is to examine the effectiveness of a comprehensive accreditation intervention with community football clubs (Rugby League, Rugby Union, soccer/association football and Australian Rules football) in reducing excessive alcohol consumption by club members. Methods and analysis The study will be conducted in New South Wales, Australia, and employ a cluster randomised controlled trial design. Half of the football clubs recruited to the trial will be randomised to receive an intervention implemented over two and a half winter sporting seasons. The intervention is based on social ecology theory and is comprehensive in nature, containing multiple elements designed to decrease the supply of alcohol to intoxicated members, cease the provision of cheap and free alcohol, increase the availability and cost-attractiveness of non-alcoholic and low-alcoholic beverages, remove high alcohol drinks and cease drinking games. The intervention utilises a three-tiered accreditation framework designed to motivate intervention implementation. Football clubs in the control group will receive printed materials on topics unrelated to alcohol. Outcome data will be collected pre- and postintervention through cross-sectional telephone surveys of club members. The primary outcome measure will be alcohol consumption by club members at the club, assessed using a graduated frequency index and a seven day diary. Ethics and dissemination The study was approved by The University of Newcastle Human Research Ethics Committee (reference: H-2008-0432). Study findings will be disseminated widely through peer-reviewed publications and conference presentations. Trial registration number Australian New Zealand Clinical Trials Registry: ACTRN12609000224224.

Project description:ImportanceHigh salt intake is associated with hypertension, which is a leading modifiable risk factor for cardiovascular disease.ObjectiveTo assess the association of a government-led, multisectoral, and population-based intervention with reduced salt intake and blood pressure in Shandong Province, China.Design, setting, and participantsThis cross-sectional study used data from the Shandong-Ministry of Health Action on Salt and Hypertension (SMASH) program, a 5-year intervention to reduce sodium consumption in Shandong Province, China. Two representative samples of adults (aged 18-69 years) were surveyed in 2011 (15 350 preintervention participants) and 2016 (16 490 postintervention participants) to examine changes in blood pressure, and knowledge, attitudes, and behaviors related to sodium intake. Urine samples were collected from random subsamples (2024 preintervention participants and 1675 postintervention participants) for measuring sodium and potassium excretion. Data were analyzed from January 20, 2017, to April 9, 2019.InterventionsMedia campaigns, distribution of scaled salt spoons, promotion of low-sodium products in markets and restaurants, and activities to support household sodium reduction and school-based sodium reduction education.Main outcomes and measuresThe primary outcome was change in urinary sodium excretion. Secondary outcomes were changes in potassium excretion, blood pressure, and knowledge, attitudes, and behaviors. Outcomes were adjusted for likely confounders. Means (95% CIs) and percentages were weighted.ResultsAmong 15 350 participants in 2011, 7683 (50.4%) were men and the mean age was 40.7 years (95% CI, 40.2-41.2 years); among 16 490 participants in 2016, 8077 (50.7%) were men and the mean age was 42.8 years (95% CI, 42.5-43.1 years). Among participants with 24-hour urine samples, 1060 (51.8%) were men and the mean age was 40.9 years (95% CI, 40.5-41.3 years) in 2011 and 836 (50.7%) were men and the mean age was 40.7 years (95% CI, 40.1-41.4 years) in 2016. The 24-hour urinary sodium excretion decreased 25% from 5338 mg per day (95% CI, 5065-5612 mg per day) in 2011 to 4013 mg per day (95% CI, 3837-4190 mg per day) in 2016 (P < .001), and potassium excretion increased 15% from 1607 mg per day (95% CI, 1511-1704 mg per day) to 1850 mg per day (95% CI, 1771-1929 mg per day) (P < .001). Adjusted mean systolic blood pressure among all participants decreased from 131.8 mm Hg (95% CI, 129.8-133.8 mm Hg) to 130.0 mm Hg (95% CI, 127.7-132.4 mm Hg) (P = .04), and diastolic blood pressure decreased from 83.9 mm Hg (95% CI, 82.6-85.1 mm Hg) to 80.8 mm Hg (95% CI, 79.4-82.1 mm Hg) (P < .001). Knowledge, attitudes, and behaviors associated with dietary sodium reduction and hypertension improved significantly.Conclusions and relevanceThe findings suggest that a government-led and population-based intervention in Shandong, China, was associated with significant decreases in dietary sodium intake and a modest reduction in blood pressure. The results of SMASH may have implications for sodium reduction and blood pressure control in other regions of China and worldwide.

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A town level comprehensive intervention study to reduce salt intake in China: protocol for a cluster randomised controlled trial.

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A town level comprehensive intervention study to reduce salt intake in China: protocol for a cluster randomised controlled trial.

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