NCT07692971

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
11.1 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 3, 2026

Last Update Submit

July 3, 2026

Conditions

Keywords

PrehypertensionDASH eating planlife style modifications

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline and Month 2

Secondary Outcomes (1)

  • Change From Baseline in Body Weight at 2 Months

    Baseline and Month 2

Study Arms (3)

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.

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.

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.

Behavioral: Lifestyle Modification AdviceBehavioral: DASH Diet

Interventions

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
DASH Diet Plus Lifestyle ModificationLifestyle Modification Advice
DASH DietBEHAVIORAL

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
DASH DietDASH Diet Plus Lifestyle Modification

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PrehypertensionHypertension

Interventions

Dietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking was used. Participants and investigators were aware of the assigned intervention because the study involved dietary and lifestyle modification interventions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2026

First Posted

July 9, 2026

Study Start

April 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 9, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared.