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Ensayo clinico aleatorio: papel de la dieta y ejercicios fisicos en mujeres con sindrome metabolico (Randomised controlled trial: the role of diet and exercise in women with metabolic syndrome) [Spanish] |
Miguel Soca PE, Pena Perez I, Nino Escofet S, Cruz Torres W, Nino Pena A, Ponce de Leon D |
Atencion Primaria 2012 Jul;44(7):387-393 |
clinical trial |
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To evaluate a program of nutritional recommendations and exercise in women with metabolic syndrome. DESIGN: Multicentre randomised controlled trial. LOCATION: Primary Health Care, Holguin, Cuba. PARTICIPANTS: A cluster sample of 150 obese women with metabolic syndrome without glucose disturbances, were randomly assigned to a control (n = 70) or experimental (n = 80) group. A total of 62 women in the control group and 60 in the intervention group completed the study (June 2008-July 2009). INTERVENTIONS: Low calorie diets and a program of exercises in the experimental group. Usual care in the control group. MEASUREMENTS: Body weight, body mass index, waist circumference, blood pressure, blood glucose and lipid profile. RESULTS: Compared to the control group, after one year, the experimental group had a lower, diastolic blood pressure (78 +/- 0.9 versus 91 +/- 1.1mm Hg), total cholesterol (4.7 +/- 0.1 versus 6.0 +/- 0.1mmol/L), triglycerides (1.9 +/- 0.0 versus 2.9 +/- 0.1mmol/L) and LDL cholesterol (2.5 +/- 0.0 versus 3.5 +/- 0.1mmol/L), and a higher HDL-cholesterol (1.2 +/- 0.0 versus 1.1 +/- 0.0mmol/L). There were no appreciable changes in weight, body mass index, waist circumference, systolic blood pressure and blood glucose. CONCLUSIONS: We demonstrated the effectiveness of the intervention program on blood pressure and blood lipid profile.
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