<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02247635</url>
  </required_header>
  <id_info>
    <org_study_id>CINYS 410</org_study_id>
    <secondary_id>000000000044415</secondary_id>
    <nct_id>NCT02247635</nct_id>
  </id_info>
  <brief_title>Effect of a Treatment of Lifestyle Changes on the Prevalence of Metabolic Syndrome and Body Weight in Mexican Women</brief_title>
  <acronym>MPATPCDNC</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mexican National Institute of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mexican National Institute of Public Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The metabolic syndrome is a group of cardiometabolic risk factors that reflect a sedentary&#xD;
      lifestyle and the excessive intake of food among the risk factors that comprise it are&#xD;
      located the obesity, hyperglycemia, dyslipidemia and hypertension.&#xD;
&#xD;
      It has been observed that the interventions of lifestyle changes that promote weight loss&#xD;
      through the practice of physical activity and intake of a hypocaloric diet, reduce the&#xD;
      prevalence of chronic diseases such as Metabolic syndrome.&#xD;
&#xD;
      Adherence is defined as the extent to which a person's behaviour - taking medication,&#xD;
      following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations&#xD;
      from a health care provider. The World Health Organization has estimated that in developing&#xD;
      countries, as in Mexico, less than 27% of people with chronic diseases will continue&#xD;
      treatment as directed.&#xD;
&#xD;
      Adherence to treatment of chronic disease is a multifactorial problem that includes not only&#xD;
      patient-related barriers, but also providers of health services and social security systems&#xD;
      themselves. Furthermore, as WHO has pointed out, as increasing prevalence of chronic&#xD;
      non-adherence to treatment will become a global problem even more serious.&#xD;
&#xD;
      The purpose of this study is develop and implement a methodology to overcome barriers&#xD;
      affecting adherence to treatment of women over 20 years with non-communicable diseases such&#xD;
      as metabolic syndrome (diabetes , hypertension and dyslipidemia) evaluating its impact&#xD;
      through various quantitative indicators such as weight loss or metabolic syndrome prevalence.&#xD;
&#xD;
      This study will include two phases:&#xD;
&#xD;
        1. Phase 1. Design. Qualitative methodology was used primarily to identify the barriers&#xD;
           faced by individuals to adhere to treatment. From this methodology, we developed a tool&#xD;
           to assess adherence to treatment of subjects with these conditions and then an&#xD;
           intervention to improve it.&#xD;
&#xD;
        2. Phase 2. Implementation of intervention (24 weeks). To recruite a group of 180&#xD;
           overweight and two of the following comorbidities: diabetes mellitus, dyslipidemia or&#xD;
           hypertension. All study subjects will be randomized to a control group and intervention.&#xD;
           The control group will receive a medical traditional clinical care. The intervention&#xD;
           group will receive a lifestyle treatment with behavioral intervention to improve&#xD;
           adherence for improve eating behaviors, physical activity and metabolic control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The World Health Organization estimates that worldwide one billion adults are overweight. In&#xD;
      Mexico, the prevalence of overweight and obesity using data from 2006 was nearly 70% in men&#xD;
      and women over 20 years.&#xD;
&#xD;
      Being overweight is associated with other co-morbidities such as diabetes mellitus (79.4%),&#xD;
      hypertension (78.0%) and dyslipidemia (82.8%). WHO has estimated that over 50% of these&#xD;
      patients have a poor grip and do not follow their treatment as indicated, generating costs&#xD;
      for managing these diseases of until $ 100 billion each year. Improve the effectiveness of&#xD;
      interventions on adherence to treatment, will significantly improve the health of these&#xD;
      patients and help reduce costs involving health systems.&#xD;
&#xD;
      The obesity and comorbidities affect 41% of the adults in Mexico and increases up to five&#xD;
      times the risk of developing cardiovascular disease and type 2 diabetes and up to three times&#xD;
      the risk of developing coronary artery disease and myocardial infarction. Therefore, these&#xD;
      diseases are currently one of the main problems of public health in Mexico.&#xD;
&#xD;
      Adherence to short and long term is the result of a complex process that develops through&#xD;
      different stages: the acceptance of diagnosis, the perceived need for treatment successfully,&#xD;
      motivation, and skills training available, the ability to overcome the barriers or&#xD;
      difficulties arise, and maintenance of achievements over time.&#xD;
&#xD;
      The lack of adherence to chronic disease is a multifactorial problem that includes not only&#xD;
      patient-related barriers, but also with service providers and health systems. Poor adherence&#xD;
      to long-term therapies severely compromises the effectiveness of treatment and negatively&#xD;
      impacts the quality of life of patients.&#xD;
&#xD;
      It has been observed that the interventions of lifestyle changes that promote weight loss&#xD;
      through the practice of physical activity and intake of a hypocaloric diet, reduce the&#xD;
      prevalence of Metabolic diseases and achieve a better control.&#xD;
&#xD;
      The changes in lifestyle are the foundation of any strategy for the treatment of chronical&#xD;
      diseases . The patients require counseling to effect change in their behavior and improve&#xD;
      their risk of mortality and morbidities. So far, interventions to improve treatment of&#xD;
      patients with chronic diseases, not including diet and exercise recommendations, has not&#xD;
      reported any significant positive change. Moreover, in Mexico there is still no method or&#xD;
      reference tool to assess adherence. It has been reported that healthy lifestyles achieve&#xD;
      positive changes on cardiovascular risk factors, however, no known methodology to help&#xD;
      patients overcome the barriers that prevent them from adopting and adhering to the&#xD;
      recommendations that are prescribed providers of health services. Therefore, the objective of&#xD;
      this study is to assess if a multidisciplinary treatment that stimulates the constant&#xD;
      practice of physical activity and intake of a hypocaloric diet, reduces the prevalence of&#xD;
      metabolic chronic diseases such as obesity, diabetes, hypertension and dyslipidemia, and&#xD;
      improves the control, in comparison with a traditional medical treatment in Mexican women.&#xD;
      Also, to develop a methodology validated in Mexican population to identify barriers that&#xD;
      affect adherence to treatment assessing their impact through a variety of quantitative&#xD;
      indicators of health.&#xD;
&#xD;
      This project was conducted in 2 phases.&#xD;
&#xD;
      PHASE 1 Development of the tool for identifying barriers. In a private hospital care to&#xD;
      chronic noncommunicable diseases, were called patients with co-morbidities associated with&#xD;
      overweight and obesity (diabetes mellitus, dyslipidemia, hypertension) to identify common&#xD;
      barriers they face to adequately follow through treatment the application of a validated&#xD;
      questionnaire. The results will be used as reference for the discussion of traditional&#xD;
      treatment algorithms based on the Mexican standards for the management of obesity,&#xD;
      hypertension, diabetes and dyslipidemia.&#xD;
&#xD;
      PHASE 2. Design and implementation of the intervention&#xD;
&#xD;
      Phase 2 began with the recruitment of study subjects. The recruitment was done by a local&#xD;
      advertising campaign that included posters and leaflets in the city the Cuernavaca, Morelos.&#xD;
      México.&#xD;
&#xD;
      Were recruited a group of 180 patients with overweight and two of the following&#xD;
      co-morbidities: diabetes mellitus, dyslipidemia or hypertension. All study subjects will be&#xD;
      randomized to a control group and intervention. The intervention will last 24 weeks. The&#xD;
      control group will receive traditional clinical care and the intervention group will receive&#xD;
      a behavioral intervention to improve adherence.&#xD;
&#xD;
      The design of the intervention is based in the the stages-of-change model (also referred to&#xD;
      as the transtheoretical model) identifies five stages through which individuals progress as&#xD;
      they change behaviours, and stage-matched strategies that predict progress to each subsequent&#xD;
      stage of change.&#xD;
&#xD;
      The stages of change are:&#xD;
&#xD;
      Precontemplation at this stage the subject does not plan to make an effort to adhere to&#xD;
      treatment or to change your behavior. (Not considering changing behavior in the next 6&#xD;
      months),&#xD;
&#xD;
      The second is called &quot;contemplation&quot;, the person admits that there is a risk behavior or&#xD;
      beneficial and begin thinking about trying to change or adopt. (Considering changing behavior&#xD;
      in the next 6 months),&#xD;
&#xD;
      The third is &quot;preparation&quot; in this stage the person intends to initiate behavior change,&#xD;
      strategies and plans to acquire solutions. (Planning to change behavior during the next 30&#xD;
      days),&#xD;
&#xD;
      The fourth is &quot;action&quot; has become the person intended in the expected action (in this study&#xD;
      the action is to improve adherence to treatment). (Currently changing behavior)&#xD;
&#xD;
      The fifth is &quot;maintenance&quot;, here the change has been established as usual. (Successful&#xD;
      behavior change for at least 6 months).&#xD;
&#xD;
      There is a sixth stage called &quot;relapse&quot;, where the person returns to the behaviors that had&#xD;
      been changed, abandoned the effort and go to the pre-action stages.&#xD;
&#xD;
      Stages of change describe an individual's motivational readiness to change.&#xD;
&#xD;
      The specific tools that contain the intervention program are:&#xD;
&#xD;
      Preparation&#xD;
&#xD;
      At this stage various strategies will be developed:&#xD;
&#xD;
        -  Educational texts&#xD;
&#xD;
        -  Individual medical advice&#xD;
&#xD;
        -  Written contract of engagement The objective of this stage is to make the individual&#xD;
           reflect on his health.&#xD;
&#xD;
      Action At this stage the individual begins proper actions to get a better adherence It will&#xD;
      provide enough printed material that allows it to achieve its goals in diet, physical&#xD;
      activity and taking medications.&#xD;
&#xD;
      There will be a computerized database (software) with which you can update the progress and&#xD;
      barriers presented by the individual and be able to access either the nutritionist doctor or&#xD;
      psychologist&#xD;
&#xD;
      Description of the tools:&#xD;
&#xD;
        -  Educational texts. Based on feedback from patients and doctors, nutritionists and&#xD;
           psychologists experts, will be designed brochures and educational leaflets with&#xD;
           practical advice to achieve intermediate goals and the end of each treatment.&#xD;
&#xD;
        -  Consultation and personalized feedback Develop a scheme for service providers (doctors,&#xD;
           nutritionists and psychologists) to provide attention individual, the query will be&#xD;
           adjusted to the level of adherence achieved.&#xD;
&#xD;
      In the query are used as reference treatment guidelines of the ADA and the Third Adult&#xD;
      Treatment Panel (ATP III).&#xD;
&#xD;
        -  Nutrition. The consultation will be given by a nutritionist trained to give dietary&#xD;
           treatment based on available activities and times of the patient.&#xD;
&#xD;
        -  Physical activity. The type of activity will be designed by an expert in the field and&#xD;
           will be prescribed by nutritionist taking into account the patient's age and abilities.&#xD;
&#xD;
      Data collection will be done with different tools according to the phase of the project&#xD;
&#xD;
      Phase 1:&#xD;
&#xD;
      a) Identification of barriers to treatment through the application of validated&#xD;
      questionnaires.&#xD;
&#xD;
      Phase 2:&#xD;
&#xD;
        1. Identification and socioeconomic data through the application of two questionnaires.&#xD;
&#xD;
        2. Anthropometry: weight with scale Tanita model BC-418. Height with stadiometer SECA,&#xD;
           model 220. Waist with a ribbon of flexible glass fiber of 0.5 cm in width and a&#xD;
           precision of 1 mm.&#xD;
&#xD;
        3. The measurement of intima-media thickness of carotid is made with Ultrasound SONOSITE&#xD;
           PLUS model 180.&#xD;
&#xD;
        4. Collection of biological samples for determination of biochemical parameters like&#xD;
           glucose, glycosylated hemoglobin, total cholesterol, HDL cholesterol, LDL cholesterol&#xD;
           and triglycerides.&#xD;
&#xD;
      Variables&#xD;
&#xD;
      Dependent. The dependent variable or outcome will be reduction in the prevalence of obesity&#xD;
      and comorbidities (such as hypertension, diabetes, dyslipidemia), and control measured&#xD;
      through weight loss, and decrease in blood pressure, fasting glucose, and cholesterol.&#xD;
&#xD;
      Independent. The independent variable is the lifestyle and behavioral program.&#xD;
&#xD;
      Data Analysis. Will present descriptive statistics for the dependent variables weight,&#xD;
      fasting glucose, HbA1c, triglycerides, HDL-C, LDL-C, blood pressure and intima-media&#xD;
      thickness.&#xD;
&#xD;
      Each group will analyze the mean difference in measurement time (initial, intermediate and&#xD;
      final) for mean difference test&#xD;
&#xD;
      The differences between the control and intervention group were analyzed using three&#xD;
      strategies: 1) by intention to treat (including patients who dropped out), 2) full support to&#xD;
      the intervention (patients who completed the program), and 3) for proper administration of&#xD;
      the intervention, ie an analysis will be specific to those subjects who received the&#xD;
      intervention effectively by the physician and nutritionist (patients intervened correctly).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2008</start_date>
  <completion_date type="Actual">August 2010</completion_date>
  <primary_completion_date type="Actual">May 2009</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in the prevalence of metabolic syndrome (obesity, diabetes, hypertension, dyslipidemia)</measure>
    <time_frame>24 weeks</time_frame>
    <description>To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction of hyperglycemia</measure>
    <time_frame>24 weeks</time_frame>
    <description>To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight loss</measure>
    <time_frame>24 weeks</time_frame>
    <description>To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction of high blood pressure</measure>
    <time_frame>24 weeks</time_frame>
    <description>To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction of hypercholesterolemia</measure>
    <time_frame>24 weeks</time_frame>
    <description>To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Obesity</condition>
  <condition>Diabetes</condition>
  <condition>High Blood Pressure</condition>
  <condition>Dyslipidemia</condition>
  <arm_group>
    <arm_group_label>Conventional medical treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy lifestyle and adherence</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1) Maintain a caloric restriction of 500kcal in overweight adults, 2) Have a total fat intake &lt;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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy lifestyle and adherence</intervention_name>
    <description>Behavioral intervention to improve adherence to treatment and 1) Maintain a caloric restriction of 500kcal in overweight adults, 2) Have a total fat intake &lt;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.&#xD;
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</description>
    <arm_group_label>Healthy lifestyle and adherence</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women from 19 to 65 years old&#xD;
&#xD;
          -  Body mass index ≥ 25.0 - ≤39.9 or abdominal obesity&#xD;
&#xD;
          -  With previous medical diagnosis:&#xD;
&#xD;
               1. high fasting glucose&#xD;
&#xD;
               2. high blood pressure&#xD;
&#xD;
               3. dyslipidemia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently pregnant or breast-feeding.&#xD;
&#xD;
          -  Anxiety and depression significantly.&#xD;
&#xD;
          -  Consumption of alcohol or smoking significantly.&#xD;
&#xD;
          -  Taking anorexigenic or other weight-loss drugs (Xenical)&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  Have polycystic ovary syndrome,&#xD;
&#xD;
          -  Kidney failure&#xD;
&#xD;
          -  Hypothyroidism,&#xD;
&#xD;
          -  Cancer,&#xD;
&#xD;
          -  Anxiety or depression&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Simón Barquera, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mexican National Institute of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mexican National Institute of Public Health</name>
      <address>
        <city>Cuernavaca,</city>
        <state>Morelos</state>
        <zip>62100</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>October 30, 2014</last_update_submitted>
  <last_update_submitted_qc>October 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mexican National Institute of Public Health</investigator_affiliation>
    <investigator_full_name>Simon Barquera, MD, MS, PhD</investigator_full_name>
    <investigator_title>Director of Research in Nutrition Policy and Programs.</investigator_title>
  </responsible_party>
  <keyword>Treatment adherence</keyword>
  <keyword>Behavioral model of health care</keyword>
  <keyword>Healthy lifestyle</keyword>
  <keyword>Chronic metabolic diseases</keyword>
  <keyword>Metabolic syndrome</keyword>
  <keyword>Obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Dyslipidemias</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02247635
org study id: CINYS 410
secondary id: 000000000044415
nct id: NCT02247635
lead sponsor: 
has dmc: Yes
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.
The World Health Organization estimates that worldwide one billion adults are overweight. In
      Mexico, the prevalence of overweight and obesity using data from 2006 was nearly 70% in men
      and women over 20 years.

      Being overweight is associated with other co-morbidities such as diabetes mellitus (79.4%),
      hypertension (78.0%) and dyslipidemia (82.8%). WHO has estimated that over 50% of these
      patients have a poor grip and do not follow their treatment as indicated, generating costs
      for managing these diseases of until $ 100 billion each year. Improve the effectiveness of
      interventions on adherence to treatment, will significantly improve the health of these
      patients and help reduce costs involving health systems.

      The obesity and comorbidities affect 41% of the adults in Mexico and increases up to five
      times the risk of developing cardiovascular disease and type 2 diabetes and up to three times
      the risk of developing coronary artery disease and myocardial infarction. Therefore, these
      diseases are currently one of the main problems of public health in Mexico.

      Adherence to short and long term is the result of a complex process that develops through
      different stages: the acceptance of diagnosis, the perceived need for treatment successfully,
      motivation, and skills training available, the ability to overcome the barriers or
      difficulties arise, and maintenance of achievements over time.

      The lack of adherence to chronic disease is a multifactorial problem that includes not only
      patient-related barriers, but also with service providers and health systems. Poor adherence
      to long-term therapies severely compromises the effectiveness of treatment and negatively
      impacts the quality of life of patients.

      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 Metabolic diseases and achieve a better control.

      The changes in lifestyle are the foundation of any strategy for the treatment of chronical
      diseases . The patients require counseling to effect change in their behavior and improve
      their risk of mortality and morbidities. So far, interventions to improve treatment of
      patients with chronic diseases, not including diet and exercise recommendations, has not
      reported any significant positive change. Moreover, in Mexico there is still no method or
      reference tool to assess adherence. It has been reported that healthy lifestyles achieve
      positive changes on cardiovascular risk factors, however, no known methodology to help
      patients overcome the barriers that prevent them from adopting and adhering to the
      recommendations that are prescribed providers of health services. Therefore, the objective of
      this study is to assess if a multidisciplinary treatment that stimulates the constant
      practice of physical activity and intake of a hypocaloric diet, reduces the prevalence of
      metabolic chronic diseases such as obesity, diabetes, hypertension and dyslipidemia, and
      improves the control, in comparison with a traditional medical treatment in Mexican women.
      Also, to develop a methodology validated in Mexican population to identify barriers that
      affect adherence to treatment assessing their impact through a variety of quantitative
      indicators of health.

      This project was conducted in 2 phases.

      PHASE 1 Development of the tool for identifying barriers. In a private hospital care to
      chronic noncommunicable diseases, were called patients with co-morbidities associated with
      overweight and obesity (diabetes mellitus, dyslipidemia, hypertension) to identify common
      barriers they face to adequately follow through treatment the application of a validated
      questionnaire. The results will be used as reference for the discussion of traditional
      treatment algorithms based on the Mexican standards for the management of obesity,
      hypertension, diabetes and dyslipidemia.

      PHASE 2. Design and implementation of the intervention

      Phase 2 began with the recruitment of study subjects. The recruitment was done by a local
      advertising campaign that included posters and leaflets in the city the Cuernavaca, Morelos.
      México.

      Were recruited a group of 180 patients with overweight and two of the following
      co-morbidities: diabetes mellitus, dyslipidemia or hypertension. All study subjects will be
      randomized to a control group and intervention. The intervention will last 24 weeks. The
      control group will receive traditional clinical care and the intervention group will receive
      a behavioral intervention to improve adherence.

      The design of the intervention is based in the the stages-of-change model (also referred to
      as the transtheoretical model) identifies five stages through which individuals progress as
      they change behaviours, and stage-matched strategies that predict progress to each subsequent
      stage of change.

      The stages of change are:

      Precontemplation at this stage the subject does not plan to make an effort to adhere to
      treatment or to change your behavior. (Not considering changing behavior in the next 6
      months),

      The second is called "contemplation", the person admits that there is a risk behavior or
      beneficial and begin thinking about trying to change or adopt. (Considering changing behavior
      in the next 6 months),

      The third is "preparation" in this stage the person intends to initiate behavior change,
      strategies and plans to acquire solutions. (Planning to change behavior during the next 30
      days),

      The fourth is "action" has become the person intended in the expected action (in this study
      the action is to improve adherence to treatment). (Currently changing behavior)

      The fifth is "maintenance", here the change has been established as usual. (Successful
      behavior change for at least 6 months).

      There is a sixth stage called "relapse", where the person returns to the behaviors that had
      been changed, abandoned the effort and go to the pre-action stages.

      Stages of change describe an individual's motivational readiness to change.

      The specific tools that contain the intervention program are:

      Preparation

      At this stage various strategies will be developed:

        -  Educational texts

        -  Individual medical advice

        -  Written contract of engagement The objective of this stage is to make the individual
           reflect on his health.

      Action At this stage the individual begins proper actions to get a better adherence It will
      provide enough printed material that allows it to achieve its goals in diet, physical
      activity and taking medications.

      There will be a computerized database (software) with which you can update the progress and
      barriers presented by the individual and be able to access either the nutritionist doctor or
      psychologist

      Description of the tools:

        -  Educational texts. Based on feedback from patients and doctors, nutritionists and
           psychologists experts, will be designed brochures and educational leaflets with
           practical advice to achieve intermediate goals and the end of each treatment.

        -  Consultation and personalized feedback Develop a scheme for service providers (doctors,
           nutritionists and psychologists) to provide attention individual, the query will be
           adjusted to the level of adherence achieved.

      In the query are used as reference treatment guidelines of the ADA and the Third Adult
      Treatment Panel (ATP III).

        -  Nutrition. The consultation will be given by a nutritionist trained to give dietary
           treatment based on available activities and times of the patient.

        -  Physical activity. The type of activity will be designed by an expert in the field and
           will be prescribed by nutritionist taking into account the patient's age and abilities.

      Data collection will be done with different tools according to the phase of the project

      Phase 1:

      a) Identification of barriers to treatment through the application of validated
      questionnaires.

      Phase 2:

        1. Identification and socioeconomic data through the application of two questionnaires.

        2. Anthropometry: weight with scale Tanita model BC-418. Height with stadiometer SECA,
           model 220. Waist with a ribbon of flexible glass fiber of 0.5 cm in width and a
           precision of 1 mm.

        3. The measurement of intima-media thickness of carotid is made with Ultrasound SONOSITE
           PLUS model 180.

        4. Collection of biological samples for determination of biochemical parameters like
           glucose, glycosylated hemoglobin, total cholesterol, HDL cholesterol, LDL cholesterol
           and triglycerides.

      Variables

      Dependent. The dependent variable or outcome will be reduction in the prevalence of obesity
      and comorbidities (such as hypertension, diabetes, dyslipidemia), and control measured
      through weight loss, and decrease in blood pressure, fasting glucose, and cholesterol.

      Independent. The independent variable is the lifestyle and behavioral program.

      Data Analysis. Will present descriptive statistics for the dependent variables weight,
      fasting glucose, HbA1c, triglycerides, HDL-C, LDL-C, blood pressure and intima-media
      thickness.

      Each group will analyze the mean difference in measurement time (initial, intermediate and
      final) for mean difference test

      The differences between the control and intervention group were analyzed using three
      strategies: 1) by intention to treat (including patients who dropped out), 2) full support to
      the intervention (patients who completed the program), and 3) for proper administration of
      the intervention, ie an analysis will be specific to those subjects who received the
      intervention effectively by the physician and nutritionist (patients intervened correctly).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Reduction in the prevalence of metabolic syndrome (obesity, diabetes, hypertension, dyslipidemia)
time frame: 24 weeks
description: To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)
measure: Reduction of hyperglycemia
time frame: 24 weeks
description: To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)
measure: Weight loss
time frame: 24 weeks
description: To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)
measure: Reduction of high blood pressure
time frame: 24 weeks
description: To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)
measure: Reduction of hypercholesterolemia
time frame: 24 weeks
description: To first week(basal), 12 weeks after recruiting (intermediate) and 24 weeks after recruiting (final evaluation)
arm group label: Conventional medical treatment
arm group type: No Intervention
description: 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
arm group label: Healthy lifestyle and adherence
arm group type: Active Comparator
description: 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.
intervention type: Behavioral
intervention name: Healthy lifestyle and adherence
description: 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
arm group label: Healthy lifestyle and adherence
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Simón Barquera, PhD
role: Principal Investigator
affiliation: Mexican National Institute of Public Health
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Mexican National Institute of Public Health
investigator full name: Simon Barquera, MD, MS, PhD
investigator title: Director of Research in Nutrition Policy and Programs.
mesh term: Hypertension
mesh term: Metabolic Syndrome
mesh term: Dyslipidemias