Korean Life-Style Modification Effects on Blood Pressure

Not Applicable

Completed

• Conditions: Prehypertension; Hypertension
• Interventions: Drug: Control group who are advised for proper life style modification by the physician such as regular exercise and healthy diet without active intervention.; Dietary Supplement: Treatment group 1(Dietary intervention); Other: Treatment group 2(dietary and exercise intervention)

• Registration Number: NCT01637909
• Lead Sponsor: Yonsei University

Brief Summary

In hypertension, lifestyle modification has been proven to be effective in reducing blood pressure while decreasing the risk of cardiovascular disease. The dietary approaches to stop hypertension(DASH) diet, sodium restriction and exercise has been shown to reduce systolic blood pressure by 8-14mmHg, 2-8mmHg and 4-9mmHg, respectively. The DASH-sodium diet has been shown to have additional systolic blood pressure lowering effect of 7.2mmHg, which is equal to adding one antihypertensive drug. However, as the dietary pattern is different in the Korean population, the investigators cannot implement the data from Western countries directly to the Korean population. For example, the consumption of dairy products is much smaller in the Korean population when compared to the western population. Therefore, the effectiveness of DASH-sodium diet and exercise on blood pressure lowering in the Korean population is not well defined. In this study, the investigators sought to determine the effectiveness of the DASH-salt diet and DASH-salt diet plus exercise on brachial blood pressure lowering. The study will be performed on untreated prehypertension patients and uncontrolled hypertensive patients undergoing anti hypertensive treatment with blood pressure measured between 140-159mmHg/90-99mmHg at the time of enrollment.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-07-08
• Study First Submitted QC: 2012-07-10
• Study First Posted: 2012-07-11
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-10
• Last Update Posted: 2015-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

1. Adult age >20

2. If the subject not taken antihypertension, SBP and DBP must be the following result.

   SBP: 120~159 mmHg , DBP: 80-99 mmHg

3. If the subject taken antihypertension, SBP and DBP must be the following result.

   SBP: 140-159mmHg ,DBP: 90-99 mmHg

4. BMI 18.5kg/m²~44kg/m²

5. Patients voluntarily agreed to participate in this study

6. Non-pregnant women, Non-breastfeeding women, women of childbearing age must be negative in HCG result.

(not taking an oral contraceptive)

Exclusion Criteria

1. If the subject not taken antihypertension, SBP and DBP must be the following result.

   • 120>SBP>159 mmHg, 80>DBP>99 mmHg

2. If the subject taken antihypertension, the number of three or more antihypertensive

3. If the subject taken antihypertension, SBP and DBP must be the following result.

   • 140>SBP>159 mmHg, 90>DBP>99 mmHg

4. having the target organ disease, the following disease.

   • Heart disease: Lt.venricular hyperplasia, Angina, MI, Coronary revascularization, Heart failure
   • Brain disease: Stroke, TIA, Dementia
   • Kidney disease:
   • Pheripheral artery disease
   • Retinopathy Disease

5. Cancer, Liver disease

6. Regular drinking alcohol above 14 cup of during 1 week.

7. Pregnant women, Women of childbearing age tested positive in HCG result.

8. Pregnant women, Breastfeeding women

9. screening test result CS

10. illiteracy, a foreigner, the person who can't read the consent

11. the person who had participated other study in 3 months.

12. the person who inappropriate to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
general management	Control group who are advised for proper life style modification by the physician such as regular exercise and healthy diet without active intervention.	-
The treatment group1	Treatment group 1(Dietary intervention)	Korean DASH diet with sodium reduction intervention
The treatment group2	Treatment group 2(dietary and exercise intervention)	Korean DASH diet with sodium reduction intervention and excersize intervention

Primary Outcome Measures

Name	Time	Method
changes of blood pressure after intervention	after 1 week, 4weeks, 8weeks intervention for each group intervention	The primary outcome will be the difference in sitting brachial systolic blood pressure after 8 weeks intervention. The study population was determined by treatment group 1 will have systolic BP lowering effect of 11.5mmHg with standard deviation of 10.0mmHg and group 2 will have systolic BP lowering effect of 18.0mmHg with standard deviation of 15.0mmHg. with statistical power of 80% and drop out rate of 25%, the number needed was determined to be 32 in the control group, 22 in group 1 and 22 in group 2.

Trial Locations

Locations (1)

Yonsei universty medical center; 🇰🇷 Seoul, Korea, Republic of