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Clinical Trials/NCT02949622
NCT02949622
Completed
N/A

Development and Validation of a Multimodal Intervention Program for Patients With Metabolic Syndrome

Universidad de Granada1 site in 1 country136 target enrollmentFebruary 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Metabolic Syndrome X
Sponsor
Universidad de Granada
Enrollment
136
Locations
1
Primary Endpoint
Waist circumference
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The aim of this study is to identify the psychological, emotional and lifestyle variables that can have an influence on the different components of metabolic syndrome (MetS) and develop a program for change lifestyle in this patients.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
October 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jaqueline Garcia da Silva

Ph.D. Student

Universidad de Granada

Eligibility Criteria

Inclusion Criteria

  • Between 25 and 65 years age
  • Waist circumference \>88 cm for women and \>102 cm for men
  • Blood pressure: systolic ≥ 130 mmHg and diastolic ≥ 85 mmHg
  • Fasting glucose level ≥ 110mg/dL
  • Triglycerides: ≥ 150 mg/dL
  • HDL cholesterol ≤40 mg/dL in men and ≤50 mg/DL in women

Exclusion Criteria

  • Osteoarthritis,
  • Active inflammatory diseases,
  • Severe psychiatric disorders and/or significant cognitive impairment assessed using the Mini-Mental State Examination.

Outcomes

Primary Outcomes

Waist circumference

Time Frame: 2 minutes

(cm). Measured using a tape measure placed in a horizontal plane, located at the midpoint between the last rib and the iliac crest

Blood pressure

Time Frame: 15 minutes

Taken according to the recommendations of the American Heart Association, and considering the mean of three readings, each separated by two minutes.

Weight

Time Frame: 2 minutes

weight (Kg)

Lipid profile

Time Frame: 3 minutes

lipid profile (HDL-C, total cholesterol, triglycerides)

Glycemic profile (fasting glucose)

Time Frame: 3 minutes

glycemic profile (fasting glucose)

Secondary Outcomes

  • Assertiveness Inventory(5 minutes)
  • Fagerström Test for Nicotine Dependence(5 minutes)
  • Perceived Stress Scale -PSS(5 minutes)
  • Medical Outcomes Study 12-Item Short Form - SF-12(5 minutes)
  • State-Trait Anger Expression Inventory-2 - STAXI-2(5 minutes)
  • Mediterranean-diet scale(5 minutes)

Study Sites (1)

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