- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07692971
Effects of the DASH Diet and Lifestyle Modification on Blood Pressure in Adults With Prehypertension (DASH-PREHT)
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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver 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.
Andere Namen:
|
|
Experimental: 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.
Andere Namen:
|
|
Experimental: 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.
Andere Namen:
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.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure at 2 Months
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change From Baseline in Body Weight at 2 Months
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2026.07.03.HLE
- Ethics Committee (Andere Kennung: 15/48)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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