PrehypertensionNCT01637909
Korean Life-Style Modification Effects on Blood Pressure
A study testing Treatment group 1(Dietary intervention) and Treatment group 2(dietary and exercise intervention) in people with Prehypertension and Hypertension, run by Yonsei University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prehypertension, Hypertension
- What is being tested?
- Treatment group 1(Dietary intervention) and Treatment group 2(dietary and exercise intervention)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2011to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult age >20
- If the subject not taken antihypertension, SBP and DBP must be the following result.
- SBP: 120~159 mmHg , DBP: 80-99 mmHg
- If the subject taken antihypertension, SBP and DBP must be the following result.
- SBP: 140-159mmHg ,DBP: 90-99 mmHg
- BMI 18.5kg/m²~44kg/m²
Show all 9Show fewer
- Patients voluntarily agreed to participate in this study
- Non-pregnant women, Non-breastfeeding women, women of childbearing age must be negative in HCG result.
- (not taking an oral contraceptive)
Who cannot join
- If the subject not taken antihypertension, SBP and DBP must be the following result.
- 120>SBP>159 mmHg, 80>DBP>99 mmHg
- If the subject taken antihypertension, the number of three or more antihypertensive
- If the subject taken antihypertension, SBP and DBP must be the following result.
- 140>SBP>159 mmHg, 90>DBP>99 mmHg
- having the target organ disease, the following disease.
Show all 19Show fewer
- Heart disease: Lt.venricular hyperplasia, Angina, MI, Coronary revascularization, Heart failure
- Brain disease: Stroke, TIA, Dementia
- Kidney disease:
- Pheripheral artery disease
- Retinopathy Disease
- Cancer, Liver disease
- Regular drinking alcohol above 14 cup of during 1 week.
- Pregnant women, Women of childbearing age tested positive in HCG result.
- Pregnant women, Breastfeeding women
- screening test result CS
- illiteracy, a foreigner, the person who can't read the consent
- the person who had participated other study in 3 months.
- the person who inappropriate to participate
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Prehypertension, Hypertension
- Being tested
- Control group who are advised for proper life style modification by the physician such as regular exercise and healthy diet without active intervention., Treatment group 1(Dietary intervention), Treatment group 2(dietary and exercise intervention)
- Keywords
- Prehypertension, Hypertension
- Medical subject headings
- Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control group who are advised for proper life style modification by the physician such as regular exercise and healthy diet without active intervention.Drug
All the study subjects will undergo baseline brachial blood pressure measurement(OMRON HEM 7080IT), central aortic blood pressure measurement with Sphygmocor device(AtCor Medical), baseline laboratory, 24hr urine Na measurement, 24 hour ambulatory blood pressure and cardiopulmonary exercise test. These tests will be repeated at the 8th week.
Treatment group 1(Dietary intervention)Dietary supplement
The dietary intervention is based on active education of the enrolled subjects based on Korean modified DASH diet. The enrolled subjects are advised to substitute processed white rice with whole grains such as barley. For protein, the subjects are advised to consume chicken and fish instead of red meat. Also, consumption of nuts are recommended where as processed foods containing high fructose corn syrup are not recommended. We will recommend to reduce salt intake by advising the subjects from adding table salts to their meals as well as adding salt during cooking. We will advise the subjects from eating pickles and condiments, which are the main source of salt in the Korean population. The degree of salt reduction before and after intervention will be assessed by 24 hour recall as well as measurement of 24 hour urine Na collection at baseline and at the 8th week. The compliance of the subjects will be assessed by 24hr recall as well.
Treatment group 2(dietary and exercise intervention)Other
The dietary intervention will be combined with exercise intervention. At baseline, the subjects will undergo evaluation for (1) cardiopulmonary function by undergoing cardiopulmonary exercise test and 3 minute step test 2) muscle strength assessment by hand grip test and 3) push ups to assess muscle endurance. After the initial evaluation, the subjects will be subjected to a course in aerobic exercise and muscle strengthening exercise developed by the Yonsei University Physical education department and will receive an educational DVD program. The subjects will each be given an electronic step counter to assess the degree of exercise. All the subjects in the treatment group 2 will be advised to undergo moderate to stenuous aerobic exercise for least 150 minutes /per week. Also, the subjects will be educated to perform muscle strengthening exercise as specificed in the educational program. The subjects will be asked to submit an exercise diary to assess the degree of compliance.
| Study group | Role | What they receive |
|---|---|---|
| general management | Active comparator | Not described Receives: Drug: 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 | Experimental | Korean DASH diet with sodium reduction intervention Receives: Dietary Supplement: Treatment group 1(Dietary intervention) |
| The treatment group2 | Experimental | Korean DASH diet with sodium reduction intervention and excersize intervention Receives: Other: Treatment group 2(dietary and exercise intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of blood pressure after 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.
Measured: after 1 week, 4weeks, 8weeks intervention for each group intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startSep 2011
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrehypertensionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637909
- Sponsor's protocol ID
- 4-2011-0305
- Status last verified
- Nov 2015
- First submitted
- 8 Jul 2012
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29968437
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korean Life-Style Modification Effects on Blood Pressure
- ClinicalTrials.gov ID
- NCT01637909
- Acronym / sponsor ID
- 4-2011-0305
- Conditions
- Prehypertension, Hypertension
- Keywords
- Prehypertension, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 11 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| general management | Active comparator | Drug: 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 | Experimental | Dietary Supplement: Treatment group 1(Dietary intervention)Korean DASH diet with sodium reduction intervention |
| The treatment group2 | Experimental | Other: Treatment group 2(dietary and exercise intervention)Korean DASH diet with sodium reduction intervention and excersize intervention |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult age >20
- If the subject not taken antihypertension, SBP and DBP must be the following result.
- SBP: 120~159 mmHg , DBP: 80-99 mmHg
- If the subject taken antihypertension, SBP and DBP must be the following result.
- SBP: 140-159mmHg ,DBP: 90-99 mmHg
Key exclusion criteria (19 listed)
- If the subject not taken antihypertension, SBP and DBP must be the following result.
- If the subject taken antihypertension, the number of three or more antihypertensive
- If the subject taken antihypertension, SBP and DBP must be the following result.
- having the target organ disease, the following disease.
- Cancer, Liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control group who are advised for proper life style modification by the physician such as regular exercise and healthy diet without active intervention.All the study subjects will undergo baseline brachial blood pressure measurement(OMRON HEM 7080IT), central aortic blood pressure measurement with Sphygmocor device(AtCor Medical), baseline laboratory, 24hr urine Na measurement, 24 hour ambulatory blood pressure and cardiopulmonary exercise test. These tests will be repeated at the 8th week. | Drug | general management |
| Treatment group 1(Dietary intervention)The dietary intervention is based on active education of the enrolled subjects based on Korean modified DASH diet. The enrolled subjects are advised to substitute processed white rice with whole grains such as barley. For protein, the subjects are advised to consume chicken and fish instead of red meat. Also, consumption of nuts are recommended where as processed foods containing high fructose corn syrup are not recommended. We will recommend to reduce salt intake by advising the subjects from adding table salts to their meals as well as adding salt during cooking. We will advise the subjects from eating pickles and condiments, which are the main source of salt in the Korean population. The degree of salt reduction before and after intervention will be assessed by 24 hour recall as well as measurement of 24 hour urine Na collection at baseline and at the 8th week. The compliance of the subjects will be assessed by 24hr recall as well. | Dietary supplement | The treatment group1 |
| Treatment group 2(dietary and exercise intervention)The dietary intervention will be combined with exercise intervention. At baseline, the subjects will undergo evaluation for (1) cardiopulmonary function by undergoing cardiopulmonary exercise test and 3 minute step test 2) muscle strength assessment by hand grip test and 3) push ups to assess muscle endurance. After the initial evaluation, the subjects will be subjected to a course in aerobic exercise and muscle strengthening exercise developed by the Yonsei University Physical education department and will receive an educational DVD program. The subjects will each be given an electronic step counter to assess the degree of exercise. All the subjects in the treatment group 2 will be advised to undergo moderate to stenuous aerobic exercise for least 150 minutes /per week. Also, the subjects will be educated to perform muscle strengthening exercise as specificed in the educational program. The subjects will be asked to submit an exercise diary to assess the degree of compliance. | Other | The treatment group2 |
Primary outcome
changes of blood pressure after intervention
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
- Derived from this study: PubMed 29968437Lee 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.
Related trials for Prehypertension
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Recruiting
Difference in Acute Responses of Vascular Function to Moderate-intensity and High-intensity Interval Training in Healthy and Prehypertensive Individuals
Prehypertension (Elevated Blood Pressure) or Hypertension, Healthy
Not yet recruiting
Behaviour Change Wheel Intervention to Promote Healthy Behaviors in Adults With Prehypertension
Prehypertension
Active, not recruiting
Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women
Overweight or Obesity, Prediabetes or Diabetes
RecruitingPhase 4
Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes
Diabetes Mellitus, Type 2, Adverse Event
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment group 1(Dietary intervention) and Treatment group 2(dietary and exercise intervention) in people with Prehypertension and Hypertension, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of blood pressure after intervention (time frame: after 1 week, 4weeks, 8weeks intervention for each group intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01637909, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2015.