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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: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT02247635
Date of registration: 17/09/2014
Prospective Registration: No
Primary sponsor: Mexican National Institute of Public Health
Public title: Effect of a Treatment of Lifestyle Changes on the Prevalence of Metabolic Syndrome and Body Weight in Mexican Women MPATPCDNC
Scientific title: 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: November 2008
Target sample size: 180
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT02247635
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
Mexico
Contacts
Name:     Simón Barquera, PhD
Address: 
Telephone:
Email:
Affiliation:  Mexican National Institute of Public Health
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Diabetes
Dyslipidemia
High Blood Pressure
Obesity
Intervention(s)
Behavioral: Healthy lifestyle and adherence
Primary Outcome(s)
Reduction in the prevalence of metabolic syndrome (obesity, diabetes, hypertension, dyslipidemia) [Time Frame: 24 weeks]
Secondary Outcome(s)
Weight loss [Time Frame: 24 weeks]
Reduction of hyperglycemia [Time Frame: 24 weeks]
Reduction of hypercholesterolemia [Time Frame: 24 weeks]
Reduction of high blood pressure [Time Frame: 24 weeks]
Secondary ID(s)
000000000044415
CINYS 410
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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