Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT02247635 |
Date of registration:
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17/09/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Effect of a Treatment of Lifestyle Changes on the Prevalence of Metabolic Syndrome and Body Weight in Mexican Women
MPATPCDNC |
Scientific title:
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Development of a Methodology for Diagnosis and Promoting Adherence to Treatment of Patients With Chronic Diseases and Evaluation of Their Impact on Cardiovascular Risk Factors |
Date of first enrolment:
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November 2008 |
Target sample size:
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180 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT02247635 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Simón Barquera, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Mexican National Institute of Public Health |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women from 19 to 65 years old
- Body mass index = 25.0 - =39.9 or abdominal obesity
- With previous medical diagnosis:
1. high fasting glucose
2. high blood pressure
3. dyslipidemia.
Exclusion Criteria:
- Currently pregnant or breast-feeding.
- Anxiety and depression significantly.
- Consumption of alcohol or smoking significantly.
- Taking anorexigenic or other weight-loss drugs (Xenical)
- Pregnant or breastfeeding
- Have polycystic ovary syndrome,
- Kidney failure
- Hypothyroidism,
- Cancer,
- Anxiety or depression
Age minimum:
20 Years
Age maximum:
65 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Diabetes
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Dyslipidemia
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High Blood Pressure
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Obesity
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Intervention(s)
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Behavioral: Healthy lifestyle and adherence
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Primary Outcome(s)
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Reduction in the prevalence of metabolic syndrome (obesity, diabetes, hypertension, dyslipidemia)
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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Weight loss
[Time Frame: 24 weeks]
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Reduction of hyperglycemia
[Time Frame: 24 weeks]
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Reduction of hypercholesterolemia
[Time Frame: 24 weeks]
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Reduction of high blood pressure
[Time Frame: 24 weeks]
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Secondary ID(s)
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000000000044415
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CINYS 410
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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