Effect of a Treatment of Lifestyle Changes on the Prevalence of Metabolic Syndrome and Body Weight in Mexican Women (MPATPCDNC)
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|ClinicalTrials.gov Identifier: NCT02247635|
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : November 3, 2014
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:
- 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.
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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)
- Reduction of hyperglycemia [ Time Frame: 24 weeks ]To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)
- Weight loss [ Time Frame: 24 weeks ]To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)
- Reduction of high blood pressure [ Time Frame: 24 weeks ]
- Reduction of hypercholesterolemia [ Time Frame: 24 weeks ]
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
|Mexican National Institute of Public Health|
|Cuernavaca,, Morelos, Mexico, 62100|
|Principal Investigator:||Simón Barquera, PhD||Mexican National Institute of Public Health|