Clinical trial NCT01637909: Korean Life-Style Modification Effects on Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prehypertension
Hypertension
Keywords: Prehypertension, Hypertension
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 85
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: changes of blood pressure after intervention
timeFrame: after 1 week, 4weeks, 8weeks intervention for each group intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei universty medical center
Study officials:
References:
citation: Lee CJ, Kim JY, Shim E, Hong SH, Lee M, Jeon JY, Park S. The Effects of Diet Alone or in Combination with Exercise in Patients with Prehypertension and Hypertension: a Randomized Controlled Trial. Korean Circ J. 2018 Jul;48(7):637-651. doi: 10.4070/kcj.2017.0349.