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Clinical Trials/NCT03558685
NCT03558685
Unknown
N/A

Weight Loss Diet in the Treatment of Obese Patients With the Metabolic Syndrome

Tel-Aviv Sourasky Medical Center0 sites120 target enrollmentJuly 2008

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity
Sponsor
Tel-Aviv Sourasky Medical Center
Enrollment
120
Primary Endpoint
% BMI Change
Last Updated
7 years ago

Overview

Brief Summary

Concomitant interventions included lifestyle modification with a personally tailored program of diet as detailed below and physical activity adjusted for age and specific physical limitations, targeting engagement in physical activity of at least 150 minutes/week. Lipid lowering and or blood pressure lowering drugs were prescribed as needed according to guideline-assisted medical practice. Patients were seen by a physician every 3 month. The dietitian had a weekly meeting with the patients for the first three months, every other week during months 4-6, once a month during month 7-9 and every 6 weeks during the last three months of the study.

Registry
clinicaltrials.gov
Start Date
July 2008
End Date
July 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • fulfilled the diagnostic criteria for the metabolic syndrome as defined by the Third Report of the Adult Treatment Panel (ATPIII).

Exclusion Criteria

  • the presence of current or recent pregnancy or intention to conceive within the trial's period
  • chronic renal or liver disease
  • past bariatric surgery
  • current participation in any dietary/ medical program with current continuous weight loss.

Outcomes

Primary Outcomes

% BMI Change

Time Frame: One Year, from the initiation of the intervention to its termination.

BMI is calculated as weight in Kg divided by height in meters X height in meters. Percent change will be calculated as the difference in BMI units (kg/m2) between the final BMI and the initial BMI, divided by the initial BMI, multiplied by 100%.

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