- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03800498
Shalamar Institute of Health Sciences
Study Overview
Status
Intervention / Treatment
Detailed Description
Objective: To explore the effect of didactic intervention regarding dietary approach to stop hypertension (DASH) on hypertensive patients blood pressure, knowledge and attitude.
Study Design: Randomized controlled trial Place and Duration of Study: Punjab Institute of Cardiology (PIC) Lahore. From June 2018 to Oct 2018.
Methodology: Seventy volunteers aged 20-60 years attending regularly outpatient department at Punjab institute of cardiology Lahore, with systolic > 130 mm hg, diastolic > 80 mm hg were selected and assigned into 2 groups, i.e. Intervention and control, by simple random lottery method. For twelve weeks, only intervention group were given DASH education. Both groups were checked for DASH knowledge, attitude, and systolic diastolic blood pressure, before and after education session. Pre-tested questionnaire was used for demographic, attitude and knowledge data collection.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Nazia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hypertensive patient aged 20-60 years attending regularly at Punjab institute of cardiology outpatient department Lahore
- systolic > 130 mm hg
- diastolic > 80 mm hg.
Exclusion Criteria:
- Less than 20 years age
- patient diagnosed with secondary hypertension
- any mental and physical ailment that may interfere the intervention like deafness and blindness.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
For twelve weeks, only intervention group were given DASH education
|
DASH health education about general knowledge of DASH diet Plan and lifestyle modification
|
|
No Intervention: Controlled
Controlled group not received DASH education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pre-tested questionnaire was used
Time Frame: 1 month
|
10 knowledge questions were asked with minimum score 0 and maximum 10.
Attitude assessment consisted of 4 questions and score range was 0-4.
|
1 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Zaheer Ahmad, PhD, Shalamar Institute of Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SIHS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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