Shandong and Ministry of Health Action on Salt and Hypertension Project (SMASH)

September 23, 2017 updated by: Ma Jixiang, Centers for Disease Control and Prevention, China

Shandong and Ministry of Health Action on Salt and Hypertension Project (SMASH)

This final evaluation intends to evaluate SMASH implementation outcomes and intervention effects through quantitative and qualitative assessment, and provide evidence for the national government to develop salt-reduction and blood-pressure lowering strategies in large scales.

Study Overview

Status

Unknown

Conditions

Detailed Description

Every year, about 1.65 million people die of excessive salt intake in the world as excessive sodium will raise blood pressure, which further increase prevalence risks of cardiovascular and kidney diseases. Therefore, reducing salt intake has been recognized as one of the most cost-effective measures for health improvement. Adopting critical salt-reduction measures can substantially reduce prevalence risks of cardiovascular and other chronic diseases. In this sense, exploring salt-reduction strategies that are widely effective among populations is critical for prevention and management of cardiovascular diseases.

The daily salt intake currently recommended by WHO is 5g (6g is recommended by Chinese government). It is estimated that 2.50 million people will not die each year if the global salt consumption is lowered to the recommended level. WHO member countries have reached an agreement to reduce 30% of the salt intake of people across the world by 2025. However, there are not enough study evidence and practical foundation for achieving the salt-reduction goal among all human beings.

Shandong is a large Chinese province with 96.85 million permanent population in its 138 counties (districts) and 62,719 communities (villages or municipal neighborhood communities). Shandong has high prevalences of cardiovascular diseases with an adult hypertensive prevalence above the national average. According to the national nutrition survey in 2002, Shandong consumed 12.6g salt per capita for daily cooking, much higher than the recommended amount (6g) in Chinese dietary guidelines. Shandong and the Ministry of Health signed a five-year cooperative agreement in 2011, Shandong-MOH Action on Salt and Hypertension ("SMASH"). The program has adopted multi-angle and multi-level intervention strategies to reduce salt intake by people for the purpose of preventing hypertension and other diseases related to salt.

SMASH baseline survey in 2011 studied 15,350 people aged 18-69 by regions and towns with multi-stage cluster random sampling to investigate their blood pressures and conditions. The survey showed that hypertensive prevalence, awareness, treatment and control rates were 23.4%, 34.5%, 27.5%, 14.9% respectively. In the baseline survey, 24-hour urine of 2,112 people was collected, and a salt intake of 13.8g per person per day was obtained in accordance with the urinary sodium data.

Since the commencement of the program, Shandong provincial government has cooperated with relevant departments to establish a work mechanism that is led by MOH, implemented by professional institutes and extensively engaged by the whole society. The program team has developed food standards and regulations and promoted salt-reduction actions in catering entities, supermarkets and food processing enterprises for a favorable environment of the program. The program team has prepared various publicity materials, and trained key groups (catering workers, food manufacturers, housewives and elementary school students). Salt consumption monitoring points and cardiovascular prevalence monitoring system have been established.

SMASH will conclude in May 2016. In order to assess the intervention course, implementation outcomes and intervention effects, the SMASH program office decided to organize a final evaluation of the program in the whole province in 2016, and quantitative data collection in June and July 2016.

Study Type

Observational

Enrollment (Anticipated)

17160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • The National Center for Chronic and Noncommunicable Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 69 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Respondents are permanent residents in the investigated counties (residence more than half a year) at ages between 6 and 69 (ID card ages), but those with severe physical or mental diseases can't participate. The survey is conducted at the same time as the SMASH baseline survey in June-July 2016. Basic demographic information, disease information, hypertension risk elements, knowledge of salt and hypertension, belief and behavior of respondents will be objectively collected and recorded through questionnaires by trained investigators from respondents. The respondents aged 18-69 are sampled from villages and urban neighborhood communities, while those aged 6-17 are sampled from schools.

Description

Inclusion Criteria:

Permanent residents in the investigated counties (residence more than half a year) at ages between 6 and 69 (ID card ages).

Exclusion Criteria:

  1. Residents with severe physical or mental diseases.
  2. Urine can't be collected due to aconuresis;
  3. The candidate has difficulty to collect urine and can't find an assistant;
  4. Patients with acute/chronic urinary tract infection, vaginal infection and perianal infection;
  5. Patients with acute hemorrhagic diseases in urinary tract, vagina and digestive tract;
  6. Women in pregnancy, lactation and menstrual periods (those whose menstruation finishes for two days are eligible);
  7. Patients with severe vomiting and diarrhea symptoms.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of hypertension
Time Frame: June-July 2016
Two blood pressure (BP) measurements were obtained using a standardized mercury sphygmomanometer after a 5-min seated rest and information on history of hypertension was obtained using a standard questionnaire. Hypertension was defined as mean systolic BP (SBP) at least 140 mmHg and/or diastolic BP (DBP) at least 90 mmHg, and/or self-reported current use of antihypertensive medication.
June-July 2016
Awareness, treatment, and control of hypertension
Time Frame: June-July 2016
Caculate the proportion of people reported having hypertension, the proportion of people reported taking medication and the proportion of them had their blood presure controlled (<140/<90 mmHg) among those classified as having hypertension.
June-July 2016
Salt intake related awareness, belief and behavior
Time Frame: June-July 2016
A face to face, close-ended questionnaire was administered by trained public health professionals. Questions collected information on: knowledge, attitudes and practices related to sodium and hypertension (relationship between sodium and hypertension, consequences of hypertension, perception of salt consumption, self-reported consumption, intention to reduce salt consumption, and practices towards reducing sodium consumption). Then caculate the KAP rates.
June-July 2016
Salt intake
Time Frame: June-July 2016
All participants were given written and verbal instructions to collect a 24 h urine sample. The samples were first assayed for creatinine concentration using the picric acid method (ADICON Clinical Laboratory; CAP accredited). The sodium concentration was determined using the direction selective electrode method. Daily salt intake was estimated by assessing 24h urinary sodium excretion based on the assumption that all sodium was ingested in the form of sodium chloride.
June-July 2016
Salt sources
Time Frame: June-July 2016
Determined by respondents filling 72-hour dietary recall questionnaires. Furthermore, the survey team asks district/county salt companies to submit sales volumes of different salt products in 2011-2015 for statistics.
June-July 2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention, China

Collaborators

Centers for Disease Control and Prevention
Shandong Province Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Ma Jixiang, MD, The National Center for Chronic and Noncommunicable Disease Control and Prevention(NCNCD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

May 31, 2016

First Submitted That Met QC Criteria

September 23, 2017

First Posted (ACTUAL)

September 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 28, 2017

Last Update Submitted That Met QC Criteria

September 23, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012GSF11828

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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