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Effect of a Treatment of Lifestyle Changes on the Prevalence of Metabolic Syndrome and Body Weight in Mexican Women (MPATPCDNC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02247635
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : November 3, 2014
Sponsor:
Information provided by (Responsible Party):
Simon Barquera, MD, MS, PhD, Mexican National Institute of Public Health

Brief Summary:

The metabolic syndrome is a group of cardiometabolic risk factors that reflect a sedentary lifestyle and the excessive intake of food among the risk factors that comprise it are located the obesity, hyperglycemia, dyslipidemia and hypertension.

It has been observed that the interventions of lifestyle changes that promote weight loss through the practice of physical activity and intake of a hypocaloric diet, reduce the prevalence of chronic diseases such as Metabolic syndrome.

Adherence is defined as the extent to which a person's behaviour - taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider. The World Health Organization has estimated that in developing countries, as in Mexico, less than 27% of people with chronic diseases will continue treatment as directed.

Adherence to treatment of chronic disease is a multifactorial problem that includes not only patient-related barriers, but also providers of health services and social security systems themselves. Furthermore, as WHO has pointed out, as increasing prevalence of chronic non-adherence to treatment will become a global problem even more serious.

The purpose of this study is develop and implement a methodology to overcome barriers affecting adherence to treatment of women over 20 years with non-communicable diseases such as metabolic syndrome (diabetes , hypertension and dyslipidemia) evaluating its impact through various quantitative indicators such as weight loss or metabolic syndrome prevalence.

This study will include two phases:

  1. Phase 1. Design. Qualitative methodology was used primarily to identify the barriers faced by individuals to adhere to treatment. From this methodology, we developed a tool to assess adherence to treatment of subjects with these conditions and then an intervention to improve it.
  2. Phase 2. Implementation of intervention (24 weeks). To recruite a group of 180 overweight and two of the following comorbidities: diabetes mellitus, dyslipidemia or hypertension. All study subjects will be randomized to a control group and intervention. The control group will receive a medical traditional clinical care. The intervention group will receive a lifestyle treatment with behavioral intervention to improve adherence for improve eating behaviors, physical activity and metabolic control.

Condition or disease Intervention/treatment Phase
Obesity Diabetes High Blood Pressure Dyslipidemia Behavioral: Healthy lifestyle and adherence Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Conventional medical treatment
Based on the clinical guidelines of the Ministry of Health, medical treatment was provided and consisted in counseling for chronic diseases such as obesity, hyperglycemia, hypertension, dyslipidemia
Active Comparator: Healthy lifestyle and adherence
1) Maintain a caloric restriction of 500kcal in overweight adults, 2) Have a total fat intake <30% (including cholesterol and trans fat), 3) A total intake of complex carbohydrates for 50%, 3) 30g fiber, 4) Perform at least 30 minutes of moderate physical activity at least 5 days a week; 5) Maintain education and behavioral therapy changes in your lifestyle.
Behavioral: Healthy lifestyle and adherence

Behavioral intervention to improve adherence to treatment and 1) Maintain a caloric restriction of 500kcal in overweight adults, 2) Have a total fat intake <30% (including cholesterol and trans fat), 3) A total intake of complex carbohydrates for 50%, 3) 30g fiber, 4) Perform at least 30 minutes of moderate physical activity at least 5 days a week; 5) Maintain education and behavioral therapy changes in your lifestyle.

The model consists of monthly visits to the doctor, nutritionist and psychologist, for screening cardiometabolic risk factors, to know limitations on treatment adherence, to start intervention to evaluate reasons for success or failure, to evaluate and maintain motivation to adherence to diet, physical activity and medication and long-term care





Primary Outcome Measures :
  1. Reduction in the prevalence of metabolic syndrome (obesity, diabetes, hypertension, dyslipidemia) [ Time Frame: 24 weeks ]
    To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)


Secondary Outcome Measures :
  1. Reduction of hyperglycemia [ Time Frame: 24 weeks ]
    To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)

  2. Weight loss [ Time Frame: 24 weeks ]
    To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)

  3. Reduction of high blood pressure [ Time Frame: 24 weeks ]
    To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)

  4. Reduction of hypercholesterolemia [ Time Frame: 24 weeks ]
    To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247635


Locations
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Mexico
Mexican National Institute of Public Health
Cuernavaca,, Morelos, Mexico, 62100
Sponsors and Collaborators
Mexican National Institute of Public Health
Investigators
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Principal Investigator: Simón Barquera, PhD Mexican National Institute of Public Health

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Responsible Party: Simon Barquera, MD, MS, PhD, Director of Research in Nutrition Policy and Programs., Mexican National Institute of Public Health
ClinicalTrials.gov Identifier: NCT02247635    
Other Study ID Numbers: CINYS 410
000000000044415 ( Other Identifier: Council of Science and Technology )
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: November 3, 2014
Last Verified: October 2014
Keywords provided by Simon Barquera, MD, MS, PhD, Mexican National Institute of Public Health:
Treatment adherence
Behavioral model of health care
Healthy lifestyle
Chronic metabolic diseases
Metabolic syndrome
Obesity
Additional relevant MeSH terms:
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Hypertension
Metabolic Syndrome
Dyslipidemias
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Vascular Diseases
Cardiovascular Diseases