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Effects of the DASH Diet and Lifestyle Modification on Blood Pressure in Adults With Prehypertension (DASH-PREHT)

3 lipca 2026 zaktualizowane przez: Antalya Bilim University

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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

32

Faza

  • Nie dotyczy

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Lifestyle Modification Advice
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.
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.
Inne nazwy:
  • Lifestyle Modification Advice DASH Diet Plus Lifestyle Modification
Eksperymentalny: DASH Diet
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.
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.
Inne nazwy:
  • DASH Diet DASH Diet Plus Lifestyle Modification
Eksperymentalny: DASH Diet Plus Lifestyle Modification
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.
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.
Inne nazwy:
  • 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.
Inne nazwy:
  • DASH Diet DASH Diet Plus Lifestyle Modification

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Systolic Blood Pressure at 2 Months
Ramy czasowe: 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.
Baseline and Month 2
Change From Baseline in Diastolic Blood Pressure at 2 Months
Ramy czasowe: 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.
Baseline and Month 2

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Body Weight at 2 Months
Ramy czasowe: Baseline and Month 2
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.
Baseline and Month 2

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 kwietnia 2015

Zakończenie podstawowe (Rzeczywisty)

1 czerwca 2015

Ukończenie studiów (Rzeczywisty)

1 czerwca 2015

Daty rejestracji na studia

Pierwszy przesłany

3 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 lipca 2026

Pierwszy wysłany (Rzeczywisty)

9 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data will not be shared.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Lifestyle Modification Advice

3
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