PrehypertensionDASH-PREHTNCT07692971
Effects of the DASH Diet and Lifestyle Modification on Blood Pressure in Adults With Prehypertension
A study testing Lifestyle Modification Advice and DASH Diet in people with Prehypertension and Prehypertension (Elevated Blood Pressure) or Hypertension, run by Antalya Bilim University.
Trial summary
This pilot randomized controlled trial evaluated the effects of the Dietary Approaches to Stop Hypertension (DASH) diet and lifestyle modification on blood pressure in adults with prehypertension. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Prehypertension, Prehypertension (Elevated Blood Pressure) or Hypertension
- What is being tested?
- Lifestyle Modification Advice and DASH Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jun 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 20 to 64 years
- Diagnosis of prehypertension based on one-week blood pressure monitoring
- Systolic blood pressure between 120 and 139 mmHg and/or diastolic blood pressure between 80 and 89 mmHg
- Willingness to participate in the study voluntarily
- Provision of written informed consent
Who cannot join
- Presence of kidney disease
- Pregnancy
- Lactation
- Diagnosis of cancer
- Use of vitamin or mineral supplements
- Performing more than 150 minutes of physical activity per week
About this study
Official title: Effects of Lifestyle Modification, the Dietary Approaches to Stop Hypertension (DASH) Diet, and Their Combination on Blood Pressure in Adults With Prehypertension: A Pilot Randomized Controlled Trial
This pilot randomized controlled trial evaluated the effects of the Dietary Approaches to Stop Hypertension (DASH) diet and lifestyle modification on blood pressure in adults with prehypertension. The study was conducted among adults aged 20-64 years who were diagnosed with prehypertension based on one-week blood pressure monitoring.
A total of 32 participants were randomly assigned to one of three groups: verbal lifestyle modification advice, DASH diet, or DASH diet combined with lifestyle modification. Participants were followed for 2 months. Blood pressure measurements were repeated at the end of the first and second months. Dietary intake, anthropometric measurements, body composition, physical activity records, and routine biochemical parameters were also assessed during the study.
Read the detailed description
This pilot randomized controlled trial was conducted to evaluate the effects of the Dietary Approaches to Stop Hypertension (DASH) diet and lifestyle modification on blood pressure in adults with prehypertension.
The study was carried out at the Internal Medicine Outpatient Clinic of Antalya Atatürk State Hospital between March 2015 and April 2015. Adults aged 20-64 years who were diagnosed with prehypertension after one week of blood pressure monitoring were included. Prehypertension was defined according to the Seventh Report of the Joint National Committee criteria as systolic blood pressure of 120-139 mmHg and/or diastolic blood pressure of 80-89 mmHg. All participants provided written informed consent before enrollment.
A total of 32 eligible participants were randomly assigned to one of three intervention groups. The first group received verbal advice on lifestyle modification, including reducing salt intake, avoiding salted foods, weight loss when body mass index was 25 kg/m² or higher, regular aerobic physical activity, and limiting alcohol consumption. The second group received an individualized DASH diet plan. For this group, resting metabolic rate and total energy requirements were calculated, and dietary plans were prepared according to the recommended DASH food group servings. The third group received both an individualized DASH diet and lifestyle modification recommendations. In this group, energy requirements for participants with body mass index of 25 kg/m² or higher were calculated according to desirable body weight, and sodium intake was controlled by providing measured daily salt amounts according to DASH recommendations.
Participants were followed for 2 months. Blood pressure measurements were performed at baseline and repeated at the end of the first and second months. Blood pressure was measured in a seated position after a 5-minute rest, with attention to avoiding smoking, caffeine, alcohol, and physical activity before measurement.
Data collection included demographic characteristics, smoking and alcohol use, physical activity status, medication and supplement use, anthropometric measurements, body composition, dietary intake, blood pressure, and routine biochemical parameters. Dietary intake was assessed using 3-day 24-hour food records at baseline, at the end of the first month, and at the end of the second month. Food frequency data were also collected at baseline and at the end of the study. Anthropometric measurements and body composition analyses were performed at baseline and at the end of the second month. Routine biochemical and hematological parameters were obtained from patient records at baseline and at the end of the second month. Physical activity was assessed using 24-hour physical activity records.
The primary purpose of the study was to compare the effects of lifestyle modification advice, the DASH diet, and the DASH diet combined with lifestyle modification on systolic and diastolic blood pressure in adults with prehypertension over a 2-month follow-up period.
- Being tested
- Lifestyle Modification Advice, DASH Diet
- Keywords
- Prehypertension, DASH eating plan, life style modifications
- Medical subject headings
- Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle Modification AdviceBehavioural
Also called Lifestyle Modification Advice DASH Diet Plus Lifestyle Modification
Participants received verbal lifestyle modification advice, including reducing salt intake, avoiding salted foods, weight loss or maintenance of normal body weight when appropriate, regular aerobic physical activity, and limiting alcohol consumption.
DASH DietBehavioural
Also called DASH Diet DASH Diet Plus Lifestyle Modification
Participants received an individualized Dietary Approaches to Stop Hypertension (DASH) diet plan. Total energy requirements were calculated, and dietary plans were prepared according to the recommended DASH food group servings. In the DASH diet plus lifestyle modification arm, sodium intake was controlled by providing measured daily salt amounts according to DASH recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Modification Advice | Active comparator | Participants in this arm received verbal lifestyle modification advice, including reducing salt intake, avoiding salted foods, weight loss when body mass index was 25 kg/m² or higher, regular aerobic physical activity, and limiting alcohol consumption. Receives: Behavioral: Lifestyle Modification Advice |
| DASH Diet | Experimental | Participants in this arm received an individualized Dietary Approaches to Stop Hypertension (DASH) diet plan. Total energy requirements were calculated, and dietary plans were prepared according to the recommended DASH food group servings. Receives: Behavioral: DASH Diet |
| DASH Diet Plus Lifestyle Modification | Experimental | Participants in this arm received an individualized DASH diet plan combined with lifestyle modification recommendations. For participants with body mass index of 25 kg/m² or higher, energy requirements were calculated according to desirable body weight. Sodium intake was controlled according to DASH recommendations, and advice on weight management, physical activity, salt reduction, and alcohol limitation was provided. Receives: Behavioral: Lifestyle Modification Advice; Behavioral: DASH Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Systolic Blood Pressure at 2 Months
Systolic blood pressure was measured in a seated position after a 5-minute rest. The outcome was defined as the change in systolic blood pressure from baseline to the end of the 2-month follow-up period.
Measured: Baseline and Month 2
Change From Baseline in Diastolic Blood Pressure at 2 Months
Diastolic blood pressure was measured in a seated position after a 5-minute rest. The outcome was defined as the change in diastolic blood pressure from baseline to the end of the 2-month follow-up period.
Measured: Baseline and Month 2
Secondary outcomes (1)
Change From Baseline in Body Weight at 2 Months
Body weight was measured using an electronic scale. The outcome was defined as the change in body weight from baseline to the end of the 2-month follow-up period.
Measured: Baseline and Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study startApr 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehypertensionStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- Participants were randomly assigned to one of three parallel intervention groups: verbal lifestyle modification advice, DASH diet, or DASH diet combined with lifestyle modification. Each participant received only the intervention assigned to their group and was followed for 2 months.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Bilim University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692971
- Sponsor's protocol ID
- 2026.07.03.HLE
- Other IDs
- Ethics Committee
- Acronym
- DASH-PREHT
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lifestyle Modification, the Dietary Approaches to Stop Hypertension (DASH) Diet, and Their Combination on Blood Pressure in Adults With Prehypertension: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07692971
- Acronym / sponsor ID
- DASH-PREHT / 2026.07.03.HLE
- Keywords
- Prehypertension, DASH eating plan, life style modifications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Antalya Bilim UniversityUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Jul 2026 (actual)
- 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.
This pilot randomized controlled trial evaluated the effects of the Dietary Approaches to Stop Hypertension (DASH) diet and lifestyle modification on blood pressure in adults with prehypertension. The study was conducted among adults aged 20-64 years who were diagnosed with prehypertension based on one-week blood pressure monitoring.
A total of 32 participants were randomly assigned to one of three groups: verbal lifestyle modification advice, DASH diet, or DASH diet combined with lifestyle modification. Participants were followed for 2 months. Blood pressure measurements were repeated at the end of the first and second months. Dietary intake, anthropometric measurements, body composition, physical activity records, and routine biochemical parameters were also assessed during the study.
Detailed description
This pilot randomized controlled trial was conducted to evaluate the effects of the Dietary Approaches to Stop Hypertension (DASH) diet and lifestyle modification on blood pressure in adults with prehypertension.
The study was carried out at the Internal Medicine Outpatient Clinic of Antalya Atatürk State Hospital between March 2015 and April 2015. Adults aged 20-64 years who were diagnosed with prehypertension after one week of blood pressure monitoring were included. Prehypertension was defined according to the Seventh Report of the Joint National Committee criteria as systolic blood pressure of 120-139 mmHg and/or diastolic blood pressure of 80-89 mmHg. All participants provided written informed consent before enrollment.
A total of 32 eligible participants were randomly assigned to one of three intervention groups. The first group received verbal advice on lifestyle modification, including reducing salt intake, avoiding salted foods, weight loss when body mass index was 25 kg/m² or higher, regular aerobic physical activity, and limiting alcohol consumption. The second group received an individualized DASH diet plan. For this group, resting metabolic rate and total energy requirements were calculated, and dietary plans were prepared according to the recommended DASH food group servings. The third group received both an individualized DASH diet and lifestyle modification recommendations. In this group, energy requirements for participants with body mass index of 25 kg/m² or higher were calculated according to desirable body weight, and sodium intake was controlled by providing measured daily salt amounts according to DASH recommendations.
Participants were followed for 2 months. Blood pressure measurements were performed at baseline and repeated at the end of the first and second months. Blood pressure was measured in a seated position after a 5-minute rest, with attention to avoiding smoking, caffeine, alcohol, and physical activity before measurement.
Data collection included demographic characteristics, smoking and alcohol use, physical activity status, medication and supplement use, anthropometric measurements, body composition, dietary intake, blood pressure, and routine biochemical parameters. Dietary intake was assessed using 3-day 24-hour food records at baseline, at the end of the first month, and at the end of the second month. Food frequency data were also collected at baseline and at the end of the study. Anthropometric measurements and body composition analyses were performed at baseline and at the end of the second month. Routine biochemical and hematological parameters were obtained from patient records at baseline and at the end of the second month. Physical activity was assessed using 24-hour physical activity records.
The primary purpose of the study was to compare the effects of lifestyle modification advice, the DASH diet, and the DASH diet combined with lifestyle modification on systolic and diastolic blood pressure in adults with prehypertension over a 2-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were randomly assigned to one of three parallel intervention groups: verbal lifestyle modification advice, DASH diet, or DASH diet combined with lifestyle modification. Each participant received only the intervention assigned to their group and was followed for 2 months.
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Modification Advice | Active comparator | Behavioral: Lifestyle Modification AdviceParticipants in this arm received verbal lifestyle modification advice, including reducing salt intake, avoiding salted foods, weight loss when body mass index was 25 kg/m² or higher, regular aerobic physical activity, and limiting alcohol consumption. |
| DASH Diet | Experimental | Behavioral: DASH DietParticipants in this arm received an individualized Dietary Approaches to Stop Hypertension (DASH) diet plan. Total energy requirements were calculated, and dietary plans were prepared according to the recommended DASH food group servings. |
| DASH Diet Plus Lifestyle Modification | Experimental | Behavioral: Lifestyle Modification Advice, Behavioral: DASH DietParticipants in this arm received an individualized DASH diet plan combined with lifestyle modification recommendations. For participants with body mass index of 25 kg/m² or higher, energy requirements were calculated according to desirable body weight. Sodium intake was controlled according to DASH recommendations, and advice on weight management, physical activity, salt reduction, and alcohol limitation was provided. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 20 to 64 years
- Diagnosis of prehypertension based on one-week blood pressure monitoring
- Systolic blood pressure between 120 and 139 mmHg and/or diastolic blood pressure between 80 and 89 mmHg
- Willingness to participate in the study voluntarily
- Provision of written informed consent
Key exclusion criteria (6 listed)
- Presence of kidney disease
- Pregnancy
- Lactation
- Diagnosis of cancer
- Use of vitamin or mineral supplements
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 |
|---|---|---|
| Lifestyle Modification AdviceAlso: Lifestyle Modification Advice DASH Diet Plus Lifestyle ModificationParticipants received verbal lifestyle modification advice, including reducing salt intake, avoiding salted foods, weight loss or maintenance of normal body weight when appropriate, regular aerobic physical activity, and limiting alcohol consumption. | Behavioural | DASH Diet Plus Lifestyle Modification, Lifestyle Modification Advice |
| DASH DietAlso: DASH Diet DASH Diet Plus Lifestyle ModificationParticipants received an individualized Dietary Approaches to Stop Hypertension (DASH) diet plan. Total energy requirements were calculated, and dietary plans were prepared according to the recommended DASH food group servings. In the DASH diet plus lifestyle modification arm, sodium intake was controlled by providing measured daily salt amounts according to DASH recommendations. | Behavioural | DASH Diet, DASH Diet Plus Lifestyle Modification |
Primary outcome
Change From Baseline in Systolic Blood Pressure at 2 Months
Time frame: Baseline and Month 2
Systolic blood pressure was measured in a seated position after a 5-minute rest. The outcome was defined as the change in systolic blood pressure from baseline to the end of the 2-month follow-up period.
Change From Baseline in Diastolic Blood Pressure at 2 Months
Time frame: Baseline and Month 2
Diastolic blood pressure was measured in a seated position after a 5-minute rest. The outcome was defined as the change in diastolic blood pressure from baseline to the end of the 2-month follow-up period.
1 secondary outcome
Change From Baseline in Body Weight at 2 Months
Time frame: Baseline and Month 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 9 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Modification Advice and DASH Diet in people with Prehypertension and Prehypertension (Elevated Blood Pressure) or Hypertension, run by Antalya Bilim University.
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 5 inclusion and 6 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 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Change From Baseline in Systolic Blood Pressure at 2 Months (time frame: Baseline and Month 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2026.