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Reducing salt intake for prevention of cardiovascular diseases in high-risk patients by advanced health education intervention (RESIP-CVD study), Northern Thailand: study protocol for a cluster randomized trial.

Trials
January 1, 1970
Myo Nyein Aung et al. (13 authors)
Journal ArticleRandomized Controlled TrialHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine whether visualizing daily salt intake and providing health education could reduce salt consumption and improve cardiovascular health in high-risk patients.

Results Summary

The study measured blood pressure changes and estimated 24-hour salt intake after a 1-year intervention involving dietary education and salt visualization. Results will compare these outcomes between intervention and control groups, but specific findings are not yet reported in the abstract.

Population

High-CVD-risk patients (800 participants) attending diabetes and hypertension clinics in Chiang Rai, Thailand.

Effective Dosage

Not specified

Duration

1 year

Interactions

None mentioned

Extracted Claims (6)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Decreasing salt consumption
decrease
cardiovascular diseases (CVD)
-
-
can prevent
#1
Health education programs visualizing daily dietary salt content and intake
increase
lifestyle changes
patients at high risk of cardiovascular diseases
-
may promote
#2
salt content in the daily diet will be measured and shown to study participants; 24-hour salt intake will be estimated in overnight-collected urine and the results shown to the participants; a dietician will assist small group health education classes in cooking meals with less salt
neutral
blood pressure change
high-CVD-risk patients attending diabetes and hypertension clinics at health centers in Muang District, Chiang Rai province, Thailand
-
-
#3
salt content in the daily diet will be measured and shown to study participants; 24-hour salt intake will be estimated in overnight-collected urine and the results shown to the participants; a dietician will assist small group health education classes in cooking meals with less salt
neutral
estimated 24-hour salt intake
high-CVD-risk patients attending diabetes and hypertension clinics at health centers in Muang District, Chiang Rai province, Thailand
-
-
#4
salt content in the daily diet will be measured and shown to study participants; 24-hour salt intake will be estimated in overnight-collected urine and the results shown to the participants; a dietician will assist small group health education classes in cooking meals with less salt
neutral
incidence of CVD events and CVD death
high-CVD-risk patients attending diabetes and hypertension clinics at health centers in Muang District, Chiang Rai province, Thailand
-
-
#5
Dietary salt reduction
decrease
CVD
individuals most vulnerable to CVD morbidity and mortality
-
will be applied as a prioritized, community level intervention for the prevention of
#6
Abstract

BACKGROUND: Decreasing salt consumption can prevent cardiovascular diseases (CVD). Practically, it is difficult to promote people's awareness of daily salt intake and to change their eating habits in terms of reducing salt intake for better cardiovascular health. Health education programs visualizing daily dietary salt content and intake may promote lifestyle changes in patients at high risk of cardiovascular diseases. METHODS/DESIGN: This is a cluster randomized trial. A total of 800 high-CVD-risk patients attending diabetes and hypertension clinics at health centers in Muang District, Chiang Rai province, Thailand, will be studied with informed consent. A health center recruiting 100 participants is a cluster, the unit of randomization. Eight clusters will be randomized into intervention and control arms and followed up for 1 year. Within the intervention clusters the following will be undertaken: (1) salt content in the daily diet will be measured and shown to study participants; (2) 24-hour salt intake will be estimated in overnight-collected urine and the results shown to the participants; (3) a dietician will assist small group health education classes in cooking meals with less salt. The primary outcome is blood pressure change at the 1-year follow-up. Secondary outcomes at the 1-year follow-up are estimated 24-hoursalt intake, incidence of CVD events and CVD death. The intention-to-treat analysis will be followed.Blood pressure and estimated 24-hour salt intake will be compared between intervention and control groups at the cluster and individual level at the 1-year follow-up. Clinical CVD events and deaths will be analyzed by time-event analysis. Retinal blood vessel calibers of CVD-risk patients will be assessed cross-sectionally. Behavioral change to reduce salt intake and the influencing factors will be determined by structured equation model (SEM). Multilevel regression analyses will be applied. Finally, the cost effectiveness of the intervention will be analyzed. DISCUSSION: This study is unique as it will recruit the individuals most vulnerable to CVD morbidity and mortality by applying the general Framingham CVD risk scoring system. Dietary salt reduction will be applied as a prioritized, community level intervention for the prevention of CVD in a developing country. TRIAL REGISTRATION: ISRCTN39416277.

Medical Subject Headings (MeSH)
Cardiovascular DiseasesClinical ProtocolsHealth EducationHumansRiskSample SizeSodium Chloride, DietaryThailand
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations12
Citations/Year0.9
Relative Citation Ratio0.47
NIH Percentile25.5%
Research Impact Scores
APT Score0.50
Weight Score1.74
Normalized Score0.67
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