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Clinical Trials/NCT00273572
NCT00273572
Completed
N/A

The Effect of a Lifestyle Intervention Program on Parameters of the Metabolic Syndrome Among Non-Diabetic Obese Arab Women

Sheba Medical Center1 site in 1 country200 target enrollmentDecember 2004

Overview

Phase
N/A
Intervention
Not specified
Conditions
Metabolic Syndrome
Sponsor
Sheba Medical Center
Enrollment
200
Locations
1
Primary Endpoint
Parameters of the metabolic syndrome
Status
Completed
Last Updated
17 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 2004
End Date
July 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • Obesity (BMI: 30-40 kg/squared meter)
  • Female Gender
  • Being 35-54 years old

Exclusion Criteria

  • A contraindication for physical activity

Outcomes

Primary Outcomes

Parameters of the metabolic syndrome

Time Frame: At baseline, and after 6 and 12 months

Secondary Outcomes

  • Quality of life(At baseline, and after 12 months)
  • Attainment of weight reduction and physical activity targets(At baseline, and after 6 and 12 months)

Study Sites (1)

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