An interventional study of Lifestyle Modification Advice and DASH Diet in Prehypertension and Prehypertension (Elevated Blood Pressure) or Hypertension, sponsored by Antalya Bilim University. Completed. Open to participants aged 20 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Antalya Bilim University · Not applicable, Interventional, and Treatment
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.
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.
158 studies on the registry are indexed under Prehypertension; 21 are open to participants now.
This study's enrollment of 32 is below the median of 66 across 138 interventional studies indexed under Prehypertension.
Browse Prehypertension studies →Antalya Bilim University is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Lifestyle Modification Advice
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.
Behavioral: DASH Diet
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.
Behavioral: Lifestyle Modification Advice · Behavioral: DASH Diet
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.
Also known as: Lifestyle Modification Advice 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.
Also known as: DASH Diet DASH Diet Plus Lifestyle Modification
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.
Time frame: 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.
Time frame: Baseline and Month 2
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.
Time frame: Baseline and Month 2
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Plan to share: No — Individual participant data will not be shared.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Antalya Bilim University