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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.
Register: REBEC
Last refreshed on: 29 April 2013
Main ID:  RBR-8ztcv9
Date of registration: 27/06/2011
Primary sponsor: Universidade Federal do Maranhão - Brazil
Public title: Impact of intervention dietary approaches to stop hypertension(dash) in hypertension and nutritional status of patients monitored in primary health
Scientific title: Impact of intervention dietary approaches to stop hypertension(dash) in hypertension and nutritional status of patients monitored in primary health
Date of first enrolment: 01/02/2010
Target sample size: 326
Recruitment status: recruiting
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-8ztcv9/
Study type: 
Study design:  Therapeutic clinical trial phase 3, open, randomized, parallel with two arms.
 
Countries of recruitment
Brazil
Contacts
Name: Silvia Tereza  Rodrigues Moreira Lima
Address:  Rua Alto Parnaíba 02 apt 801 Ponta do Farol 65075830 São Luis-MA Brazil
Telephone: (98) 81427476
Email: silviaterezam@gmail.com
Affiliation:  Universidade Federal do Maranhão
Name: Silvia Tereza  Rodrigues Moreira Lima
Address:  Rua Alto Parnaíba 02 apt 801 Ponta do Farol 65075830 São Luis-MA Brazil
Telephone: (98) 81427476
Email: silviaterezam@gmail.com
Affiliation:  Universidade Federal do Maranhão
Key inclusion & exclusion criteria
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: -
Health Condition(s) or Problem(s) studied
hypertension, nutritional status
C14.907.489
Intervention(s)
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.
Primary Outcome(s)
blood pressure reduction after 3 measurements measured by sphygmomanometer
reduction in BMI by 10%
Secondary Outcome(s)
reduced metabolic rates (total cholesterol and fractions, triglycerides, blood glucose and glycated hemoglobin)
reduction of sodium intake
Secondary ID(s)
003128/2009-70
Source(s) of Monetary Support
Fundação de Amparo a Pesquisa do Estado do Maranhão-FAPEMA - Brazil
Secondary Sponsor(s)
Universidade do Estado do Rio de Janeiro - Brazil
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