The study protocol aims to test the hypothesis that a lifestyle intervention program aimed to increase leisure-time physical activity and reduce body weight will improve the parameters of the metabolic syndrome and quality of life among obese, non-diabetic Arab women
200 obese non-diabetic Arab women, 35-54 years old, with one or more parameters of the metabolic syndrome (NCEP-III criteria) will be randomized to either conventional or intensive treatment. The intensive intervention arm will include group meetings with physical education instructor (twice a month),group meetings with a dietician (once per month) and personal dietary counselling (once per month). The targets to be achieved will be at least 7% reduction of the initial body weight and engagement in leisure-time sports activity for at least 150 min/week.Evaluation before enrollment and at the end of the trial will include: information on dietary and physical activity habits, quality of life parameters, anthropometric and blood pressure measurement, blood lipid profile, and fasting and post oral glucose load blood glucose and insulin levels. Duration of the intervention: 12 month.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
200
Two educational group meetings with a dietitian in the first month of intervention; One individual counselling session with a dietitian at baseline, and at 6-month and 12-month follow-up
A monthly individual counselling session with a dietitian; A monthly group session with a dietitian; Bi-monthly group sessions with a physical activity instructor
Unit of Cardiovascular Epidemiology, Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center
Tel-Hashomer, Ramat-Gan, Israel
Parameters of the metabolic syndrome
Time frame: At baseline, and after 6 and 12 months
Quality of life
Time frame: At baseline, and after 12 months
Attainment of weight reduction and physical activity targets
Time frame: At baseline, and after 6 and 12 months
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