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Restaurant interventions for salt reduction in China: protocol for a randomised controlled trial.

ABSTRACT: Introduction: Salt intake in China is high, and most of it comes from that added by consumers. Nevertheless, recent years have seen a rapid increase in the frequency at which people eat out. The aim of this study is to evaluate the effectiveness of interventions designed for salt reduction in restaurants through a randomised controlled trial in China.

Methods and analysis: As a randomised controlled trial with restaurants as study subjects, we recruited 192 restaurants from 12 counties of 6 provinces in China. After the baseline survey, restaurants were randomly assigned to intervention or control group. Using social cognitive theory, comprehensive intervention activities were designed to encourage salt reduction in all restaurant foods, and at the same time, to encourage consumers to choose lower salt options when eating out. The interventions will be conducted only in restaurants of the intervention group during the first year. The follow-up assessment will be conducted at the end of the trial. The primary outcome is the change in the average salt content of the five best-selling dishes of the restaurant, as measured by laboratory tests. Secondary outcomes include differences in the monthly use of salt and salty condiments between intervention and control restaurants, and the knowledge, attitude and practice on salt among restaurant consumers.

Ethics and dissemination: The study was reviewed and approved by the Review Board of the National Institute for Nutrition and Health, 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: ChiCTR1800019694; Pre-results.

SUBMITTER: Du W

PROVIDER: S-EPMC7713225 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Restaurant interventions for salt reduction in China: protocol for a randomised controlled trial.

Du Wenwen W Zhang Jiguo J Li Yuan Y He Feng J FJ Zhou Xue X Xu Zhihua Z Gao Yifu Y Yin Lei L Chang Xiaoyu X Yan Wei W Tan Monique M MacGregor Graham A GA Luo Rong R Zhang Puhong P Wang Huijun H

BMJ open 20201202 12

<h4>Introduction</h4>Salt intake in China is high, and most of it comes from that added by consumers. Nevertheless, recent years have seen a rapid increase in the frequency at which people eat out. The aim of this study is to evaluate the effectiveness of interventions designed for salt reduction in restaurants through a randomised controlled trial in China.<h4>Methods and analysis</h4>As a randomised controlled trial with restaurants as study subjects, we recruited 192 restaurants from 12 count ...[more]

PMID: 33268406

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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:Surgical site infection (SSI) is a common complication following abdominal surgery. It is associated with considerable morbidity and mortality, and its management results in significant cost to health services within both primary and secondary care. Some surgeons believe that the use of a wound-edge protection device may reduce the incidence of SSI. Whilst there is some encouraging evidence showing that such devices may lead to a reduction in SSI, there are no controlled trials of sufficient size or quality to support their routine use.750 patients will be recruited from around 20 surgical units within the United Kingdom. Patients undergoing laparotomy through any major abdominal incision for any indication, elective or emergency, are eligible. Patients under the age of 18, those undergoing a laparoscopic assisted procedure or who have undergone laparotomy within the previous 3 months, and those who are unable to give informed consent will be excluded. Patients will be randomised (1:1 ratio) to the use of a wound-edge protection device or no wound-edge protection device during surgery. Follow up will consist of blinded clinical wound reviews at 5-7 days and 30-33 days postoperatively with a self-completed questionnaire covering the intervening period. Quality of life questionnaires will be completed prior to surgery and at the subsequent wound review points and information on resource usage will also be captured.The primary outcome measure is SSI within 30 days of surgery. Secondary outcomes include the impact of the degree of wound contamination, patient comorbidity, and operative characteristics on the efficacy of a wound-edge protection device in reducing SSI and whether the use of a wound-edge protection device has an effect on health-related quality of life or length of hospital stay and is cost-effective.Rossini is the first multicentre observer-blinded randomised controlled trial of sufficient size and quality to establish whether the use of a wound-edge protection device in adult patients undergoing abdominal surgery leads to a lower rate of SSI. The results of this study will be used to inform current surgical practice and may potentially benefit patients undergoing surgery in the future.Current Controlled Trials ISRCTN: ISRCTN40402832.

Project description:IntroductionDiabetes affects more than 425?million people worldwide with a lifetime risk of diabetic foot ulcer (DFU) of up to 25%. Management includes wound debridement, wound dressings, offloading, treatment of infection and ischaemia, optimising glycaemic control; use of advanced adjuvant therapies is limited by high cost and lack of robust evidence.Methods and analysisA multicentre, seamless phase II/III, open, parallel group, multi-arm multi-stage randomised controlled trial in patients with a hard-to-heal DFU, with blinded outcome assessment. A maximum of 447 participants will be randomised (245 participants in phase II and 202 participants in phase III). The phase II primary objective will determine the efficacy of treatment strategies including hydrosurgical debridement ± decellularised dermal allograft, or the combination with negative pressure wound therapy, as an adjunct to treatment as usual (TAU), compared with TAU alone, with patients randomised in a 1:1:1:2 allocation. The outcome is achieving at least 50% reduction in index ulcer area at 4 weeks post randomisation.The phase III primary objective will determine whether one treatment strategy, continued from phase II, reduces time to healing of the index ulcer compared with TAU alone, with participants randomised in a 1:1 allocation. Secondary objectives will compare healing status of the index ulcer, infection rate, reulceration, quality of life, cost-effectiveness and incidence of adverse events over 52 weeks post randomisation. Phase II and phase III primary endpoint analysis will be conducted using a mixed-effects logistic regression model and Cox proportional hazards regression, respectively. A within-trial economic evaluation will be undertaken; the primary economic analysis will be a cost-utility analysis presenting ICERs for each treatment strategy in rank order of effectiveness, with effects expressed as quality-adjusted life years.The trial has predefined progression criteria for the selection of one treatment strategy into phase III based on efficacy, safety and costs at 4 weeks.Ethics and disseminationEthics approval has been granted by the National Research Ethics Service (NRES) Committee Yorkshire and The Humber - Bradford Leeds Research Ethics Committee; approved 26 April 2017; (REC reference: 17/YH/0055). There is planned publication of a monograph in National Institute for Health Research journals and main trial results and associated papers in high-impact peer-reviewed journals.Trial registration numberISRCTN64926597; registered on 6 June 2017.

Project description:INTRODUCTION:Amyotrophic lateral sclerosis (ALS) is a rapid and fatal motor disease marked by progressive physical impairment due to muscle weakness and wasting. It is multidimensional with many patients presenting with cognitive and/or behavioural impairment. Caregivers of patients with ALS, commonly non-paid immediate family members, often take primary responsibility for the complex care needs of patients in non-medicalised setting, and many as a consequence experience caregiver burden, anxiety, and/or depression. METHODS AND ANALYSIS:This randomised controlled trial (RCT) will use randomisation to allocate n=75 caregivers of patients with ALS from the national ALS clinic into three groups with an equal distribution. The RCT consists of two intervention groups and a wait list control (treatment as usual [TAU]) group. The intervention arms of the trial consist of a 'mindfulness-based stress reduction' and 'building better caregivers' manualised group-based intervention, with 9 and 6 weekly sessions, respectively. The TAU group will have access to intervention at the end of the trial period. Primary outcomes are self-report questionnaires on anxiety and depression symptoms, with caregiver burden and quality of life considered secondary outcomes. Assessment will commence at baseline, immediately following the intervention period, and after a period of 12 weeks to assess the effectiveness and efficacy of participating in an intervention. Patient cognitive and behavioural data will also be considered. Means of treatment and control groups at Time 0 and 1 will be analysed using mixed model multivariate analysis of variance followed by analysis of variance, and treatment effect-sizes will be calculated. This RCT protocol is pre-results and has been registered with an international database resulting in an International Standard Randomised Controlled Trials Number (ISRCTN53226941). ETHICS AND DISSEMINATION:Ethics approval was obtained from the Beaumont Hospital Medical Research Ethics Committee. Results of the main trial will be submitted for publication in a peer-reviewed journal.

Project description:RATIONALE AND OBJECTIVE:Salt reduction remains a global challenge and different salt reduction strategies have been studied in China. This study is to systematically evaluate evidence from randomised controlled trials (RCT) in China and inform the effective salt reduction strategies. DESIGN:Systematic review and meta-analysis. DATA SOURCES:MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Wanfang Data and the China National Knowledge Infrastructure databases through October 2019. ELIGIBILITY CRITERIA:RCTs conducted in China with at least 4?weeks' duration of study and blood pressure (BP) reported. DATA EXTRACTION AND SYNTHESIS:Data were screened, extracted and appraised by two independent reviewers. The quality of study was assessed using a modified Cochrane Collaboration's risk of bias tool. The primary outcome was the difference in BP change from baseline to the end of study between interventions and control. The effects were pooled using a random effects model and associated factors were explored by a meta-regression. RESULTS:We identified 24 studies involving 10?448 participants, including 8 studies on health education (4583 participants), 2 studies on salt restriction diet (162 participants), 1 study on salt restriction spoon (50 participants) and 13 studies on salt substitute (5653 participants). Six studies on salt substitute and three studies on health education were identified with high quality. Pooled results from the six studies showed that salt substitutes significantly reduced systolic BP (-5.7?mm Hg; 95%?CI -8.5 to -2.8) and diastolic BP (-2.0?mm Hg; 95%?CI -3.5 to -0.4). The School-EduSalt study showed that the school-based health education significantly reduced systolic BP among parents (-2.3?mm Hg; 95%?CI -4.5 to -0.04). CONCLUSIONS:Among four salt reduction strategies studied in China with RCT design, only salt substitute was proved effective in lowering BP by the pooled effect from multiple studies with high quality. More well-designed studies are warranted for other strategies.

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Restaurant interventions for salt reduction in China: protocol for a randomised controlled trial.

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Restaurant interventions for salt reduction in China: protocol for a randomised controlled trial.

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