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Main
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Note: This record shows only the 20 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. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-8ztcv9 |
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Date of registration:
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27/06/2011 |
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Primary sponsor: |
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Public title:
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Impact of intervention dietary approaches to stop hypertension(dash) in hypertension and nutritional status of patients monitored in primary health
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Scientific title:
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Impact of intervention dietary approaches to stop hypertension(dash) in hypertension and nutritional status of patients monitored in primary health |
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Date of first enrolment:
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01/02/2010 |
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Target sample size:
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326 |
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Recruitment status: |
recruiting |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-8ztcv9/ |
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Study type:
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Study design:
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Therapeutic clinical trial phase 3, open, randomized, parallel with two arms.
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Silvia Tereza
Rodrigues Moreira Lima |
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Address:
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Rua Alto Parnaíba 02 apt 801 Ponta do Farol
65075830
São Luis-MA
Brazil |
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Telephone:
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(98) 81427476 |
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Email:
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silviaterezam@gmail.com |
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Affiliation:
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Universidade Federal do Maranhão |
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Name:
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Silvia Tereza
Rodrigues Moreira Lima |
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Address:
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Rua Alto Parnaíba 02 apt 801 Ponta do Farol
65075830
São Luis-MA
Brazil |
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Telephone:
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(98) 81427476 |
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Email:
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silviaterezam@gmail.com |
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Affiliation:
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Universidade Federal do Maranhão |
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Key inclusion & exclusion criteria
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Inclusion criteria: hypertension enrolled in the program HIPERDIA Ministry of Health and regular monitoring in primary health care unit
Exclusion criteria: Pregnant, patients with chronic kidney disease and Renal Replacement Therapy and chronic illnesses comsuptiva
Age minimum:
20Y
Age maximum:
0Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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hypertension, nutritional status C14.907.489
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Intervention(s)
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Experimental group will perform nutritional assessment, measurement of blood pressure at every visit, for a period of 6 months, biochemical tests at 1 and 6 months and assessment of food intake (1, 3 and 6 months).They will receive individualized nutritional guidance based on the principles of the study dash, although adapted to local realities, respecting the local diet habits during the intervention period and will be conducted educational lectures on healthy eating. The control group will receive the same actions, except for nutritional guidance that will be held at the end of the study.
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Primary Outcome(s)
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blood pressure reduction after 3 measurements measured by sphygmomanometer
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reduction in BMI by 10%
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Secondary Outcome(s)
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reduced metabolic rates (total cholesterol and fractions, triglycerides, blood glucose and glycated hemoglobin)
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reduction of sodium intake
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Secondary ID(s)
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003128/2009-70
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Source(s) of Monetary Support
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Fundação de Amparo a Pesquisa do Estado do Maranhão-FAPEMA - Brazil
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