NCT03296332

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
17,160

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
10 months until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 28, 2017

Status Verified

September 1, 2017

Enrollment Period

5.9 years

First QC Date

May 31, 2016

Last Update Submit

September 23, 2017

Conditions

Keywords

EvaluationPopulation-based InterventionSalt intakeHypertension

Outcome Measures

Primary Outcomes (5)

  • Prevalence of hypertension

    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

    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

    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

    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

    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

Eligibility Criteria

Age6 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The National Center for Chronic and Noncommunicable Disease Control and Prevention

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (11)

  • Zhang J, Xu AQ, Ma JX, Shi XM, Guo XL, Engelgau M, Yan LX, Li Y, Li YC, Wang HC, Lu ZL, Zhang JY, Liang XF. Dietary sodium intake: knowledge, attitudes and practices in Shandong Province, China, 2011. PLoS One. 2013;8(3):e58973. doi: 10.1371/journal.pone.0058973. Epub 2013 Mar 18.

  • Bi Z, Liang X, Xu A, Wang L, Shi X, Zhao W, Ma J, Guo X, Zhang X, Zhang J, Ren J, Yan L, Lu Z, Wang H, Tang J, Cai X, Dong J, Zhang J, Chu J, Engelgau M, Yang Q, Hong Y, Wang Y. Hypertension prevalence, awareness, treatment, and control and sodium intake in Shandong Province, China: baseline results from Shandong-Ministry of Health Action on Salt Reduction and Hypertension (SMASH), 2011. Prev Chronic Dis. 2014 May 22;11:E88. doi: 10.5888/pcd11.130423.

  • Xu J, Wang M, Chen Y, Zhen B, Li J, Luan W, Ning F, Liu H, Ma J, Ma G. Estimation of salt intake by 24-hour urinary sodium excretion: a cross-sectional study in Yantai, China. BMC Public Health. 2014 Feb 8;14:136. doi: 10.1186/1471-2458-14-136.

  • Zhang JY, Yan LX, Tang JL, Ma JX, Guo XL, Zhao WH, Zhang XF, Li JH, Chu J, Bi ZQ. Estimating daily salt intake based on 24 h urinary sodium excretion in adults aged 18-69 years in Shandong, China. BMJ Open. 2014 Jul 18;4(7):e005089. doi: 10.1136/bmjopen-2014-005089.

  • Yan L, Ma J, Guo X, Tang J, Zhang J, Lu Z, Wang H, Cai X, Wang L. Urinary albumin excretion and prevalence of microalbuminuria in a general Chinese population: a cross-sectional study. BMC Nephrol. 2014 Oct 13;15:165. doi: 10.1186/1471-2369-15-165.

  • Li JH, Xu AQ, Lu ZL, Yan LX, Guo XL, Wang HC, Ma JX, Zhang JY, Dong J, Wang LH. Dietary sodium intake and its impact factors in adults of Shandong province. Biomed Environ Sci. 2014 Jul;27(7):564-6. doi: 10.3967/bes2014.087.

  • Ge Z, Guo X, Chen X, Zhang J, Yan L, Tang J, Cai X, Xu A, Ma J. Are Microalbuminuria and Elevated 24 H Urinary Microalbumin Excretion within Normal Range Associated with Metabolic Syndrome in Chinese Adults? PLoS One. 2015 Sep 17;10(9):e0138410. doi: 10.1371/journal.pone.0138410. eCollection 2015.

  • Chen X, Guo X, Ma J, Zhang J, Tang J, Yan L, Xu C, Zhang X, Ren J, Lu Z, Zhang G, Dong J, Xu A. Urinary sodium or potassium excretion and blood pressure in adults of Shandong province, China: preliminary results of the SMASH project. J Am Soc Hypertens. 2015 Oct;9(10):754-762. doi: 10.1016/j.jash.2015.07.004. Epub 2015 Jul 26.

  • Ge Z, Zhang J, Chen X, Yan L, Guo X, Lu Z, Xu A, Ma J. Are 24 h urinary sodium excretion and sodium:potassium independently associated with obesity in Chinese adults? Public Health Nutr. 2016 Apr;19(6):1074-80. doi: 10.1017/S136898001500230X. Epub 2015 Jul 31.

  • Yan L, Bi Z, Tang J, Wang L, Yang Q, Guo X, Cogswell ME, Zhang X, Hong Y, Engelgau M, Zhang J, Elliott P, Angell SY, Ma J. Relationships Between Blood Pressure and 24-Hour Urinary Excretion of Sodium and Potassium by Body Mass Index Status in Chinese Adults. J Clin Hypertens (Greenwich). 2015 Dec;17(12):916-25. doi: 10.1111/jch.12658. Epub 2015 Aug 29.

  • Zhang J, Guo XL, Seo DC, Xu AQ, Xun PC, Ma JX, Shi XM, Li N, Yan LX, Li Y, Lu ZL, Zhang JY, Tang JL, Ren J, Zhao WH, Liang XF. Inaccuracy of Self-reported Low Sodium Diet among Chinese: Findings from Baseline Survey for Shandong & Ministry of Health Action on Salt and Hypertension (SMASH) Project. Biomed Environ Sci. 2015 Feb;28(2):161-7. doi: 10.3967/bes2015.022.

Biospecimen

Retention: SAMPLES WITH DNA

We used blood samples of 17,160 respondents to test blood glucose and blood lipids and 24-hour urinary samples of 1820 respondents in total to investigate the changes in sodium/salt intake.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Ma Jixiang, MD

    The National Center for Chronic and Noncommunicable Disease Control and Prevention(NCNCD)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy director, The National Center for Chronic and Noncommunicable Disease Control and Prevetion(NCNCD)

Study Record Dates

First Submitted

May 31, 2016

First Posted

September 28, 2017

Study Start

January 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

September 28, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations