Dataset Information

The Effects of a Community-Based Sodium Reduction Program in Rural China - A Cluster-Randomized Trial.

ABSTRACT:

Background

Average sodium intake and stroke mortality in northern China are both among the highest in the world. An effective, low-cost strategy to reduce sodium intake in this population is urgently needed.

Objective

We sought to determine the effects of a community-based sodium reduction program on salt consumption in rural northern China.

Design

This study was a cluster-randomized trial done over 18 months in 120 townships (one village from each township) from five provinces. Sixty control villages were compared to 60 intervention villages that were given access to a reduced-sodium, added-potassium salt substitute in conjunction with a community-based health education program focusing on sodium reduction. The primary outcome was the difference in 24-hour urinary sodium excretion between randomized groups.

Results

Among 1,903 people with valid 24-hour urine collections, mean urinary sodium excretion in intervention compared with control villages was reduced by 5.5% (-14mmol/day, 95% confidence interval -26 to -1; p = 0.03), potassium excretion was increased by 16% (+7mmol/day, +4 to +10; p<0.001), and sodium to potassium ratio declined by 15% (-0.9, -1.2 to -0.5; p<0.001). Mean blood pressure differences were -1.1 mm Hg systolic (-3.3 to +1.1; p = 0.33) and -0.7 mm Hg diastolic (-2.2 to +0.8, p = 0.35) and the difference in the proportion with hypertension was -1.3% (-5.1 to 2.5, p = 0.56).

Conclusion

There were clear differences in population sodium and potassium intake between villages that were most likely a consequence of increased use of salt substitute. The absence of effects on blood pressure reflects the moderate changes in sodium and potassium intake achieved.

Trial registration

Clinicaltrials.gov identifier: NCT01259700.

SUBMITTER: Li N

PROVIDER: S-EPMC5147834 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Publications

The Effects of a Community-Based Sodium Reduction Program in Rural China - A Cluster-Randomized Trial.

Li Nicole N Yan Lijing L LL Niu Wenyi W Yao Chen C Feng Xiangxian X Zhang Jianxin J Shi Jingpu J Zhang Yuhong Y Zhang Ruijuan R Hao Zhixin Z Chu Hongling H Zhang Jing J Li Xian X Pan Jianhong J Li Zhifang Z Sun Jixin J Zhou Bo B Zhao Yi Y Yu Yan Y Engelgau Michael M Labarthe Darwin D Ma Jixiang J MacMahon Stephen S Elliott Paul P Wu Yangfeng Y Neal Bruce B

PloS one 20161209 12

<h4>Background</h4>Average sodium intake and stroke mortality in northern China are both among the highest in the world. An effective, low-cost strategy to reduce sodium intake in this population is urgently needed.<h4>Objective</h4>We sought to determine the effects of a community-based sodium reduction program on salt consumption in rural northern China.<h4>Design</h4>This study was a cluster-randomized trial done over 18 months in 120 townships (one village from each township) from five provi ...[more]

PMID: 27935977

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Project description:Purpose: A clustered-randomized controlled trial was conducted to determine the effects of a sodium reduction program in 120 rural villages in Northern China. This mixed-methods process evaluation was used to investigate the implementation and to evaluate the feasibility of the complex intervention to translate the findings from clinical study to the real world. Methods: A convergent mixed-methods process evaluation design was used in this study. Quantitative data were collected from activity logs and routine study records. Qualitative data were collected from 53 project stakeholders and 45 villagers from 10 intervention villages. Thematic analysis of qualitative interviews facilitated integration with the descriptive quantitative data analysis based on theory-informed domains of fidelity, delivery, reach, receipt, and contextual factors of intervention from a process evaluation framework. Results: The intervention was implemented with high fidelity, delivery, reach, and receipt. A total of 5,450 sheets of posters, 31,400 calendars, and 78,000 sheets of stickers were delivered as planned, and 11 promotion activities were conducted in each village. Contextual factors hindering full uptake of the intervention included preference for salty taste, higher cost of low-sodium salt, and low education levels of villagers. Other contextual factors, positive policy support, administrative support, and staff enthusiasm were the facilitators for implementation. Conclusions: This multifaceted intervention was implemented well and effectively in rural China. This process evaluation has indicated that conducting health education interventions in rural areas requires policy and administrative support, enthusiastic staff, easy-to-understand health education materials and activities, and key persons, but tempered expectations as behavior change requires time. This project demonstrates the feasibility and benefits of using mixed-methods process evaluation in large-scale studies.

Project description:Inadequate care during early childhood can lead to long-term deficits in skill development. Parenting programs are promising tools for improving parenting practices and opportunities for healthy development. We implemented a non-masked cluster-randomized controlled trial in rural China in order to assess the effectiveness of an integrated home-visitation program that includes both psychosocial stimulation and health promotion at fostering development and health outcomes of infants and toddlers in rural China. All 6-18 month-old children of two rural townships and their main caregiver were enrolled. Villages were stratified by township and randomly assigned to intervention or control. Specifically, in September 2015 we assigned 43 clusters to treatment (21 villages, 222 caregiver-child dyads) or control (22 villages, 227 caregiver-child dyads). In the intervention group, community health workers delivered education and training on how to provide young children with psychosocial stimulation and health care (henceforth psychosocial stimulation and health promotion) during bi-weekly home visits over the period of one year. The control group received no home visits. Primary outcomes include measures of child development (i.e. the Bayley Scales of Infant and Toddler Development, third edition-or Bayley-III) and health (i.e. measures of morbidity, nutrition, and growth). Secondary outcomes are measures of parenting practices. Intention-to-treat (ITT) effects show that the intervention led to an improvement of 0·24 standard deviations (SD) [95% CI 0·04 SD-0·44 SD] in cognitive development and to a reduction of 8·1 [95% CI 3·8-12·4] percentage points in the risk of diarrheal illness. In addition, we find positive effects on parenting practices mirroring these results. We conclude that an integrated psychosocial stimulation and health promotion program improves development and health outcomes of infants and toddlers (6-30 month-old children) in rural China. Because of low incremental costs of adding program components (that is, adding health promotion to psychosocial stimulation programs), integrated programs may be cost-effective.

Project description:BACKGROUND:In recent years, attempts have been made to use mobile phone text messaging (short message service, SMS) to achieve positive results for a range of health issues. Reports on the impact of maternal education programs based on this widely available, inexpensive, and instant communication tool are sparse. OBJECTIVE:This study aimed to explore the impact of a maternal education program through text messaging. METHODS:We conducted a cluster randomized trial in a remote region in the Chinese province of Hunan between October 1, 2011, and December 31, 2012. We used county as the unit of randomization (a total of 10 counties), with half of the counties randomly allocated to the intervention arm (with maternal education material adapted from the World Health Organization being delivered by text messaging to village health workers and pregnant women alike) and the other half to the control arm (normal care without text messaging). Data on maternal and infant health outcomes and health behaviors were collected and compared between the 2 arms, with maternal and perinatal mortality as the primary outcomes. RESULTS:A total of 13,937 pregnant women completed the follow-up and were included in the final analysis. Among them, 6771 were allocated to the intervention arm and 6966 were allocated to the control arm. At the county level, the mean (SD) of maternal mortality and perinatal mortality rate were 0.0% (0.1) and 1.3% (0.6), respectively, in the intervention arm and 0.1% (0.2) and 1.5% (0.4), respectively, in the control arm. However, these differences were not statistically significant. At the individual level, there were 3 maternal deaths (0.04%) and 84 perinatal deaths (1.24%) in the intervention arm and 6 maternal deaths (0.09%) and 101 perinatal deaths (1.45%) in the control arm. However, the differences were again not statistically significant. CONCLUSIONS:Adequate resources should be secured to launch large-scale cluster randomized trials with smaller cluster units and more intensive implementation to confirm the benefits of the text messaging-based maternal education program suggested by this trial. TRIAL REGISTRATION:ClinicalTrials.gov NCT01775150; https://clinicaltrials.gov/ct2/show/NCT01775150 (Archived by WebCite at http://www.webcitation.org/74cHmUexo).

Project description:ObjectivesTo test the impact of provider performance pay for anaemia reduction in rural China.DesignA cluster randomised trial of information, subsidies, and incentives for school principals to reduce anaemia among their students. Enumerators and study participants were not informed of study arm assignment.Setting72 randomly selected rural primary schools across northwest China.Participants3553 fourth and fifth grade students aged 9-11 years. All fourth and fifth grade students in sample schools participated in the study.InterventionsSample schools were randomly assigned to a control group, with no intervention, or one of three treatment arms: (a) an information arm, in which principals received information about anaemia; (b) a subsidy arm, in which principals received information and unconditional subsidies; and (c) an incentive arm, in which principals received information, subsidies, and financial incentives for reducing anaemia among students. Twenty seven schools were assigned to the control arm (1816 students at baseline, 1623 at end point), 15 were assigned to the information arm (659 students at baseline, 596 at end point), 15 to the subsidy arm (726 students at baseline, 667 at end point), and 15 to the incentive arm (743 students at baseline, 667 at end point).Main outcome measuresStudent haemoglobin concentrations.ResultsMean student haemoglobin concentration rose by 1.5 g/L (95% CI -1.1 to 4.1) in information schools, 0.8 g/L (-1.8 to 3.3) in subsidy schools, and 2.4 g/L (0 to 4.9) in incentive schools compared with the control group. This increase in haemoglobin corresponded to a reduction in prevalence of anaemia (Hb <115 g/L) of 24% in incentive schools. Interactions with pre-existing incentives for principals to achieve good academic performance led to substantially larger gains in the information and incentive arms: when combined with incentives for good academic performance, associated effects on student haemoglobin concentration were 9.8 g/L (4.1 to 15.5) larger in information schools and 8.6 g/L (2.1 to 15.1) larger in incentive schools.ConclusionsFinancial incentives for health improvement were modestly effective. Understanding interactions with other motives and pre-existing incentives is critical.Trial registration numberISRCTN76158086.

Project description:IntroductionReducing Latino preschoolers' TV viewing is needed to reduce their risk of obesity and other chronic diseases. This study's objective was to evaluate the Fit 5 Kids (F5K) TV reduction program's impact on Latino preschooler's TV viewing.Study designCluster RCT with randomization at the center level and N=160 participants.Setting/participantsLatino children aged 3-5 years and their parents were recruited from six Head Start centers in Houston TX in 2010-2012 with analyses in 2013-2014.InterventionF5K was culturally adapted for Latino preschoolers and the overall goal was to reduce TV viewing. Study staff taught F5K over 7-8 weeks during the regular Head Start day directly to intervention students. Control schools provided the usual Head Start curriculum, which did not specifically cover TV viewing.Main outcome measuresIndividual-level outcomes were measured prior to (Time 1) and immediately following (Time 2) the intervention. The primary outcome, TV viewing (minutes/day), was measured by validated 7-day TV diaries (parent-reported). Sedentary time was measured by accelerometers.ResultsPer the adjusted repeated measures linear mixed effects model for TV viewing (minutes/day), intervention children decreased from 76.2 (9.9) at Time 1 to 52.1 (10.0) at Time 2, whereas control children remained about the same from 84.2 (10.5) at Time 1 to 85.4 (10.5) at Time 2. The relative difference from Time 1 to Time 2 was -25.3 (95% CI= -45.2, -5.4) minutes for intervention versus control children (N=160, p=0.01). In a similar adjusted model, there was a relative decrease in sedentary time (minutes/day) from Time 1 to Time 2 favoring the intervention children (-9.5, 95% CI= -23.0, 4.1), although not significant at p<0.05.ConclusionsF5K reduced Latino preschoolers' TV viewing by >25 minutes daily. These findings have implications for prevention of obesity, related disorders, and health equity.Trial registrationThis study is registered at www.clinicaltrials.gov NCT01216306.

Project description:BackgroundCardiovascular disease (CVD) is a major cause of death in China. Despite government efforts, the majority of hypertensive and diabetic patients in China do not receive proper treatment. Reducing CVD events requires long-term care that is proactive, patient-centred, community-based, and sustainable. We have designed a package of interventions for patients at high risk of CVD to be implemented by family doctors based in township hospitals (providers of primary care) in rural Zhejiang, China. This trial aims to determine whether the systematic CVD risk reduction package results in reduced CVD events among patients at risk of CVD compared with usual care, and whether the package is cost-effective and suitable for routine implementation and scale-up.Methods/designThis is a prospective, open-label, cluster randomized controlled trial (RCT) with blinded data analysis. The trial will randomize 67 township hospitals with 31,708 participants in three counties in Zhejiang Province. Participants will be identified from existing health records and will comprise adults aged 50 to 74 years, with a calculated 10-year CVD risk of 20% or higher, or diabetes. In the intervention arm, participants will receive a package of interventions including: 1) healthy lifestyle counseling (smoking cessation, and salt, oil, and alcohol reduction); 2) prescription of a combination of drugs (antihypertensives, aspirin, and statin); and 3) adherence support for drug compliance and healthy lifestyle change. In the control arm, participants will receive usual care for hypertension and diabetes management at individual clinicians' discretion. The primary outcome is the incidence of severe CVD events over 24 months of follow-up. All CVD events will be defined according to the World Health Organization (WHO) monitoring of trends and determinants in cardiovascular disease (MONICA) definitions, diagnosed at the county hospital or higher level, and reported by the Zhejiang surveillance system. Secondary outcomes include: mean systolic and diastolic blood pressure, blood glucose, serum total cholesterol (TC), and adherence to appointments, and drugs and lifestyle changes.DiscussionThis trial focuses on risk reduction of CVD rather than specific diseases. It is not designed to compare therapeutic and healthy lifestyle interventions, but rather their combined effects in primary care settings. Through the trial, we intend to understand the effectiveness of the comprehensive CVD reduction package in routine practice. We also intend to understand the barriers and facilitators to implementing the package, and thus to advise on policy and practice change.Trial registrationCurrent Controlled Trials: ISRCTN58988083.

Dataset Information

The Effects of a Community-Based Sodium Reduction Program in Rural China - A Cluster-Randomized Trial.

Background

Objective

Design

Results

Conclusion

Trial registration

Publications

The Effects of a Community-Based Sodium Reduction Program in Rural China - A Cluster-Randomized Trial.

Similar Datasets

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