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A large-scale cluster randomized trial to determine the effects of community-based dietary sodium reduction--the China Rural Health Initiative Sodium Reduction Study.

ABSTRACT: Cardiovascular diseases are the leading cause of death and disability in China. High blood pressure caused by excess intake of dietary sodium is widespread and an effective sodium reduction program has potential to improve cardiovascular health.This study is a large-scale, cluster-randomized, trial done in five Northern Chinese provinces. Two counties have been selected from each province and 12 townships in each county making a total of 120 clusters. Within each township one village has been selected for participation with 1:1 randomization stratified by county. The sodium reduction intervention comprises community health education and a food supply strategy based upon providing access to salt substitute. Subsidization of the price of salt substitute was done in 30 intervention villages selected at random. Control villages continued usual practices. The primary outcome for the study is dietary sodium intake level estimated from assays of 24-hour urine.The trial recruited and randomized 120 townships in April 2011. The sodium reduction program was commenced in the 60 intervention villages between May and June of that year with outcome surveys scheduled for October to December 2012. Baseline data collection shows that randomisation achieved good balance across groups.The establishment of the China Rural Health Initiative has enabled the launch of this large-scale trial designed to identify a novel, scalable strategy for reduction of dietary sodium and control of blood pressure. If proved effective, the intervention could plausibly be implemented at low cost in large parts of China and other countries worldwide.

SUBMITTER: Li N

PROVIDER: S-EPMC3919684 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature

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A large-scale cluster randomized trial to determine the effects of community-based dietary sodium reduction--the China Rural Health Initiative Sodium Reduction Study.

Li Nicole N Yan Lijing L LL Niu Wenyi W Labarthe Darwin D Feng Xiangxian X Shi Jingpu J Zhang Jianxin J Zhang Ruijuan R Zhang Yuhong Y Chu Hongling H Neiman Andrea A Engelgau Michael M Elliott Paul P Wu Yangfeng Y Neal Bruce B

American heart journal 20131009 5

<h4>Background</h4>Cardiovascular diseases are the leading cause of death and disability in China. High blood pressure caused by excess intake of dietary sodium is widespread and an effective sodium reduction program has potential to improve cardiovascular health.<h4>Design</h4>This study is a large-scale, cluster-randomized, trial done in five Northern Chinese provinces. Two counties have been selected from each province and 12 townships in each county making a total of 120 clusters. Within eac ...[more]

PMID: 24176436

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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:TRIAL DESIGN:With the rise in prevalence of non-communicable diseases in India and Kerala in particular, efforts to develop lifestyle interventions have increased. However, contextualised interventions are limited. We developed and implemented contextualised behavioural intervention strategies focusing on household dietary behaviours in selected rural areas in Kerala and conducted a community-based pragmatic cluster randomized controlled trial to assess its effectiveness to increase the intake of fruits and vegetables at individual level, and the procurement of fruits and vegetables at the household level and reduce the consumption of salt, sugar and oil at the household level. METHODS:Six out of 22 administrative units in the northern part of Thiruvananthapuram district of Kerala state were selected as geographic boundaries and randomized to either intervention or control arms. Stratified sampling was carried out and 30 clusters comprising 6-11 households were selected in each arm. A cluster was defined as a neighbourhood group functioning in rural areas under a state-sponsored community-based network (Kudumbasree). We screened 1237 households and recruited 479 (intervention: 240; control: 239) households and individuals (male or female aged 25-45 years) across the 60 clusters. 471 households and individuals completed the intervention and end-line survey and one was excluded due to pregnancy. Interventions were delivered for a period of one-year at household level at 0, 6, and 12 months, including counselling sessions, telephonic reminders, home visits and general awareness sessions through the respective neighbourhood groups in the intervention arm. Households in the control arm received general dietary information leaflets. Data from 478 households (239 in each arm) were included in the intention-to-treat analysis, with the household as the unit of analysis. RESULTS:There was significant, modest increase in fruit intake from baseline in the intervention arm (12.5%); but no significant impact of the intervention on vegetable intake over the control arm. There was a significant increase in vegetable procurement in the intervention arm compared to the control arm with the actual effect size showing an overall increase by19%; 34% of all households in the intervention arm had increased their procurement by at least 20%, compared to 17% in the control arm. Monthly household consumption of salt, sugar and oil was greatly reduced in the intervention arm compared to the control arm with the actual effect sizes showing an overall reduction by 45%, 40% and 48% respectively. CONCLUSIONS:The intervention enabled significant reduction in salt, sugar and oil consumption and improvement in fruit and vegetable procurement at the household level in the intervention arm. However, there was a disconnect between the demonstrated increase in FV procurement and the lack of increase in FV intake. We need to explore fruit and vegetable intake behaviour further to identify strategies or components that would have made a difference. We can take forward the lessons learned from this study to improve our understanding of human dietary behaviour and how that can be changed to improve health within this context.

Project description:The current evidence on handwashing and sanitation programs suggests limited impacts on health when at-scale interventions have been tested in isolation. However, no published experimental evidence currently exists that tests the interaction effects between sanitation and handwashing. We present the results of two large-scale, government-led handwashing and sanitation promotion campaigns in rural Tanzania, with the objective of tracing the causal chain from hygiene and sanitation promotion to changes in child health outcomes and specifically testing for potential interaction effects of combining handwashing and sanitation interventions.The study is a factorial cluster-randomized control trial where 181 rural wards from 10 districts in Tanzania were randomly assigned to receive sanitation promotion, handwashing promotion, both interventions together or neither (control). Interventions were rolled out from February 2009 to June 2011 and the endline survey was conducted from May to November 2012, approximately one year after program completion. The sample was composed of households with children under 5 years old in the two largest villages in each ward. Masking was not possible due to the nature of the intervention, but enumerators played no part in the intervention and were blinded to treatment status. The primary outcome of interest was 7-day diarrhea prevalence for children under five. Intermediate outcomes of behavior change including improved latrine construction, levels of open defecation and handwashing with soap were also analyzed. Secondary health outcomes included anemia, height-for-age and weight-for-age of children under 5. An intention-to-treat analysis was used to assess the relationship between the interventions and outcomes of interest.One year after the end of the program, ownership of improved latrines increased from 49.7% to 64.8% (95% CI 57.9%-71.7%) and regular open defecation decreased from 23.1% to 11.1% (95% CI 3.5%-18.7%) in sanitation promotion-only wards. Households in handwashing promotion-only wards showed marginal improvements in handwashing behavior related to food preparation but not at other critical junctures. There were no detectable interaction effects for the combined intervention. The associated cost-per-household gaining access to improved sanitation is estimated to be USD $194. Final effects on child health measured through diarrhea, anemia, stunting and wasting were absent in all treatment groups.Although statistically significant, the changes in intermediate outcomes achieved through each intervention in isolation were not large enough to generate meaningful health impacts. With no observable signs of interaction, the combined intervention produced similar results. The study highlights the importance of focusing on intermediate outcomes of take up and behavior change as a critical first step in large-scale programs before realizing the changes in health that sanitation and hygiene interventions aim to deliver.Clinicaltrials.gov NCT01465204.

Dataset Information

A large-scale cluster randomized trial to determine the effects of community-based dietary sodium reduction--the China Rural Health Initiative Sodium Reduction Study.

Publications

A large-scale cluster randomized trial to determine the effects of community-based dietary sodium reduction--the China Rural Health Initiative Sodium Reduction Study.

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