Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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17 October 2016 |
Main ID: |
ISRCTN85037713 |
Date of registration:
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07/06/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The effect of a nutrition education intervention based on the dietary approaches to stop hypertension diet pattern on blood pressure among adults with mild-to-moderate hypertension in Asesewa, Ghana
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Scientific title:
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Can a nutrition education intervention based on the dietary approaches to stop hypertension (DASH) diet pattern in addition to the standard of care have a greater blood pressure lowering effect than the standard of care alone among adults diagnosed with hypertension in Asesewa, Ghana? |
Date of first enrolment:
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09/03/2015 |
Target sample size:
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100 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN85037713 |
Study type:
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Interventional |
Study design:
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Single-center single-blind (only study participants blinded) randomized control trial (Treatment)
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Phase:
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Countries of recruitment
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Ghana
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Contacts
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Name:
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Esi
Colecraft |
Address:
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Nutrition and Food Science Department
University of Ghana
LG134
Accra
Ghana |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Adults = 25 years 2. Newly diagnosed, or previously diagnosed but not currently on treatment, as having high blood pressure (HBP) (defined as systolic blood pressure (SBP) reading of greater than 140 mmHg and or diastolic blood pressure (DBP) >90 mgHg) through the hospital-based screening at the Asesewa Government Hospital during a 4-month participant recruitment period 3. Willing to participate and provide informed consent
Exclusion criteria: 1. Persons with heart disease, diabetes mellitus, or diabetes requiring insulin 2. Persons with special dietary requirements 3. Persons unwilling to make dietary modifications
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension Circulatory System Hypertensive diseases
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Intervention(s)
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A total of 100 adults newly diagnosed with high blood pressure (defined as Systolic Blood Pressure [SBP] >140 and Diastolic Blood Pressure [DBP] >90 mmHG) at the Asesewa Government Hospital will be randomized to receive either the standard of care alone (control group) or the standard of care plus nutrition education based on the DASH dietary pattern and emphasizing meal planning based on Ghanaian foods (intervention group) . At the time of enrolment into the study (baseline), background sociodemographic information will be collected through face-to face interviews using a structured questionnaire, and dietary assessment completed using a 7-day food frequency questionnaire and the 24-hour dietary recall method. Additionally anthropometric measurements (weight, height, waist and hip circumferences) will be taken. Blood pressure will be monitored bi-weekly for the first 6 weeks and then every 3 weeks for the next 6 weeks (total of 5 visits). Total duration of the intervention will be 12 weeks (3 months). Dietary assessments and anthropometric measurements will be repeated during the 12th week of the study.
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Primary Outcome(s)
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Systolic and diastolic blood pressure. Mean change in blood pressure from enrolment to the end of the study will be compared between the control and intervention groups controlling for background socio-demographic, and anthropometric characteristics and baseline values.
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Secondary Outcome(s)
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Data were collected at 5 time points corresponding to : baseline (time or enrolment into the study); visit 1 (2 weeks post enrolment); visit 2 (4 weeks post enrolment); visit 3 (6 weeks post enrolment); visit 4 (9 weeks post enrolment): and visit 5 (12 weeks post enrolment)
1. Blood pressure taken with a digital blood pressure monitor at enrolment and each visit subsequently 2. Sociodemographic characteristics: semi-structured, pre-coded questionnaire administered at baseline (enrolment) 3. Dietary assessment: using 24-hour dietary recall method and 7-day food frequency questionnaire. Data collected at baseline and 12 weeks post enrolment 4. Anthropometric measurements: height (taken at baseline) and weight and visceral fat % (taken at baseline and every visit) measured with a digital weighing scale.
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Secondary ID(s)
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URF/6/ILG-007/2012-2013
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Source(s) of Monetary Support
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Office for Research Innovation and Development, University of Ghana
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Results
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Results available:
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Date Posted:
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Date Completed:
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