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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. |
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Register:
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REBEC |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
RBR-5n9g5f |
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Date of registration:
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17/05/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Vencer Saúde project: study protocol for healthy weight loss with nutritional and exercise training monitoring
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Scientific title:
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Healthy weight loss program: nutrition monitoring and physical activity for overweight people
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Date of first enrolment:
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09/08/2014 |
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Target sample size:
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Recruitment status: |
Data analysis completed |
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URL:
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http://ensaiosclinicos.gov.br/rg/RBR-5n9g5f |
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Study type:
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Intervention |
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Study design:
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Treatment clinical trial, randomized-controlled, parallel, single-blind, with two arms.
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Phase:
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N/A
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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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Raquel Simões
Mendes Netto |
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Address:
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Avenida Marechal Rondon, s/n, Jardim Rosa Elze
49100-000
São Cristóvão
Brazil |
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Telephone:
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+55 (79) 3194 6662 |
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Email:
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raquelufs@gmail.com |
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Affiliation:
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Universidade Federal de Sergipe - UFS |
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Name:
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Raquel Simões
Mendes Netto |
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Address:
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Avenida Marechal Rondon, s/n, Jardim Rosa Elze
49100-000
São Cristóvão
Brazil |
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Telephone:
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+55 (79) 3194 6662 |
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Email:
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raquelufs@gmail.com |
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Affiliation:
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Universidade Federal de Sergipe - UFS |
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Key inclusion & exclusion criteria
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Inclusion criteria: Age between 18 and 59 years; Body mass index of 25 kg/m² to 39.9 kg/m²; weight stable in the last three months; sedentary.
Exclusion criteria: use of drugs for weight loss; eating disorders; osteoarticular diseases; diabetes mellitus; hypertension.
Age minimum:
18Y
Age maximum:
59Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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F01.829.458.705
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Nutritional and metabolic diseases; Obesity, Abdominal; Sedentary Lifestyle
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C18.654.726.500.697
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Intervention(s)
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G11.427.590.530.698.277
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D09.301
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E02.642.249.200
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Behavioural
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Experimental group: 53 overweight or obese subject to diet with reduced carbohydrate (< 40% of total calories) performing exercise 3x a week for 12 weeks.
Control group: 53 overweight or obese subject to diet with adequate carbohydrate (55% of total calories) performing exercise 3x a week for 12 weeks.
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Primary Outcome(s)
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5 - 10% weight loss, assessed by electronic weighing after 12 weeks of intervention following a hypocaloric, carbohydrate restricted diet and high intensity intermittent exercise.
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Weight Loss about 7.5% in both groups after 12 weeks of intervention.
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Secondary Outcome(s)
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Improvement of the lipid profile, characterized by increased HDL-c concentration (+6.8 mg/dl) and reduction of LDL-c (-17 mg/dl) and total cholesterol (-26 mg/dl) in both groups after 12 weeks of intervention.
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Improvement of the lipid, hormonal and hematological profile in the experimental group. Evaluated from a sample of venous blood collected by venous puncture in the antecubital vein, before and after 12 weeks of intervention with a low calorie diet with carbohydrate restriction associated with the practice of intermittent high intensity exercise.
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Source(s) of Monetary Support
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Fundação de Apoio à Pesquisa e Inovação Tecnológica de Sergipe - FAPITEC/SE
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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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URL:
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