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

C

Centers for Disease Control and Prevention, China

Status

Unknown

Conditions

Hypertension

Study type

Observational

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT03296332
2012GSF11828

Details and patient eligibility

About

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.

Full 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.

Enrollment

17,160 estimated patients

Sex

All

Ages

6 to 69 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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