<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/NCT03296722</url>
  </required_header>
  <id_info>
    <org_study_id>NC002</org_study_id>
    <nct_id>NCT03296722</nct_id>
  </id_info>
  <brief_title>Effect of a Nutritional Intervention That Incorporates the Transtheoretical Model</brief_title>
  <official_title>Effect of a Nutritional Intervention That Incorporates the Transtheoretical Model of Motivation to Change in Healthy Eating in Patients With Cardiovascular Risk Factors: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cardiovascular diseases are the main responsible for the global burden of disease for&#xD;
      non-communicable diseases. Its treatment and prevention is aimed at generating changes in the&#xD;
      habits of life; however, the percentages of non-adherence are very high. The objective of the&#xD;
      study was to evaluate the effect of a nutritional intervention in patients with&#xD;
      cardiovascular risk that incorporates the transtheoretical model and motivational interviews&#xD;
      on the progression in the stages of change to improve adherence to healthy eating. Methods:&#xD;
      the investigators included 105 patients who came to the first time at clinical nutrition&#xD;
      service in external consultation of National Institute of Medical Sciences and Nutrition&#xD;
      Salvador Zubirán, were randomized to intervention group or control group and the stage of&#xD;
      change of the transtheoretical model, presence or absence of anxiety and depression,&#xD;
      anthropometry, blood pressure, physical activity, and food frequency, to determine the&#xD;
      quality and quantity of food intake, were evaluated. Used X² and t-test for the comparison of&#xD;
      baseline data between groups and repeated measures ANOVA to assess differences in&#xD;
      post-intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators included 105 patients that were randomized to intervention group or control&#xD;
      group. The control group comprised 41 patients, that continued with the usual intervention of&#xD;
      Clinical Nutrition Service in external consultation, attending once a month to receive&#xD;
      nutritional intervention with the prescription of a hypocaloric diet on the part of the&#xD;
      nutritionist. And the intervention group made up of 42 patients using the TM and MI through&#xD;
      sessions group and sessions individual with topics of healthy eating habits taught by a&#xD;
      nutritionist, physical activity and exercise manual taught by a physical therapist,&#xD;
      preparation of healthy food with menu taught by graduates in gastronomy and confrontation of&#xD;
      barriers given by a psychologist.&#xD;
&#xD;
      Both groups had a monthly monitoring for 3 months. The diet that was prescribed to the&#xD;
      intervention group was with the characteristics of the DASH diet, according to the most&#xD;
      recent international guides of the ACC and AHA, for the reduction of cardiovascular risk.&#xD;
&#xD;
      Once included in the study were applied to the following questionnaires to identify the stage&#xD;
      of change according to the TM; Hospital Anxiety and Depression Scale (HAD) to evaluate the&#xD;
      presence of anxiety and depression; 24-hours recall of multiple steps; Food consumption&#xD;
      frequency to determine the quantity and quality of food intake and the Rapid Assessment&#xD;
      Physical Activity Scale (RAPA), to determine the type, duration and intensity of physical&#xD;
      activity of the subject. In addition, we measured weight, height, waist circumference, hip,&#xD;
      and blood pressure.&#xD;
&#xD;
      Finally were described and analyzed each of the variables according to the visits in which&#xD;
      patients were cited.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2016</start_date>
  <completion_date type="Actual">April 28, 2017</completion_date>
  <primary_completion_date type="Actual">December 13, 2016</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight</measure>
    <time_frame>3 months</time_frame>
    <description>Weight loss</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Adherence to Fad Diet (Symptom)</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group comprised 41 patients, which was to go once a month to receive nutritional intervention with the prescription of a hypocaloric diet on the part of the nutritionist. The control group had a monthly monitoring for 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group made up of 42 patients using the transtheoretical model and MI through sessions group and sessions individual with topics of healthy eating habits taught by a nutritionist, physical activity and exercise manual taught by a physical therapist, preparation of healthy food with menu taught by graduates in gastronomy and confrontation of barriers given by a psychologist. The intervention group had a monthly monitoring for 3 months. The diet that was prescribed to the intervention group was with the characteristics of the DASH diet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The Transtheoretical Model</intervention_name>
    <description>Intervention with the Transtheoretical Model, through group and individual sessions with topics of healthy eating habits taught by a dietician, physical activity and exercise manual taught by a physical therapist, preparation of healthy food with menu taught by graduates in gastronomy, confrontation of barriers given by a psychologist. This group had a monthly monitoring during 3 months. The food plan that was prescribed to the intervention group was with the characteristics of the DASH diet, according to the most recent international guides of the ACC and AHA, for the reduction of cardiovascular risk.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Men and women volunteers over the age of 18 years. Referees for first time of the&#xD;
             various specialties and subspecialties of the INCMNSZ.&#xD;
&#xD;
          -  They have e-mail, telephone or personal cell phones.&#xD;
&#xD;
          -  Which could go one time every month to consultation.&#xD;
&#xD;
        Submitted at least 2 of the following comorbidities:&#xD;
&#xD;
          -  Overweight or obese (BMI ≥ 25kg/m2)&#xD;
&#xD;
          -  DM2 with pharmacological treatment, but without treatment with insulin.&#xD;
&#xD;
          -  Hypertension (≥140/90 mmHg) with or without medication&#xD;
&#xD;
          -  Waist circumference greater than 80 cm women and greater than 90 cm men&#xD;
&#xD;
          -  Hypertriglyceridemia (&gt;150 mg/dl), HDL-cholesterol &lt;40 mg/dl in men and &lt;50 mg/dl in&#xD;
             women. Were selected those that have two or more cardiovascular risk factors (obesity,&#xD;
             hypertension, DM2 or dyslipidemia.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Diagnosis of major depression&#xD;
&#xD;
          -  Cancer&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Acute and chronic diseases such as renal failure (GFR ˂ 30 ml/min/1.21m2)&#xD;
&#xD;
          -  Disease of liver and/or heart failure&#xD;
&#xD;
          -  Respiratory disease&#xD;
&#xD;
          -  Bariatric surgery&#xD;
&#xD;
          -  Morbid obesity (BMI ≥40 kg/m2).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 2, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>February 5, 2019</last_update_submitted>
  <last_update_submitted_qc>February 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</investigator_affiliation>
    <investigator_full_name>LILIA CASTILLO MARTINEz</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03296722
org study id: NC002
nct id: NCT03296722
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Cardiovascular diseases are the main responsible for the global burden of disease for
      non-communicable diseases. Its treatment and prevention is aimed at generating changes in the
      habits of life; however, the percentages of non-adherence are very high. The objective of the
      study was to evaluate the effect of a nutritional intervention in patients with
      cardiovascular risk that incorporates the transtheoretical model and motivational interviews
      on the progression in the stages of change to improve adherence to healthy eating. Methods:
      the investigators included 105 patients who came to the first time at clinical nutrition
      service in external consultation of National Institute of Medical Sciences and Nutrition
      Salvador Zubirán, were randomized to intervention group or control group and the stage of
      change of the transtheoretical model, presence or absence of anxiety and depression,
      anthropometry, blood pressure, physical activity, and food frequency, to determine the
      quality and quantity of food intake, were evaluated. Used X² and t-test for the comparison of
      baseline data between groups and repeated measures ANOVA to assess differences in
      post-intervention.
The investigators included 105 patients that were randomized to intervention group or control
      group. The control group comprised 41 patients, that continued with the usual intervention of
      Clinical Nutrition Service in external consultation, attending once a month to receive
      nutritional intervention with the prescription of a hypocaloric diet on the part of the
      nutritionist. And the intervention group made up of 42 patients using the TM and MI through
      sessions group and sessions individual with topics of healthy eating habits taught by a
      nutritionist, physical activity and exercise manual taught by a physical therapist,
      preparation of healthy food with menu taught by graduates in gastronomy and confrontation of
      barriers given by a psychologist.

      Both groups had a monthly monitoring for 3 months. The diet that was prescribed to the
      intervention group was with the characteristics of the DASH diet, according to the most
      recent international guides of the ACC and AHA, for the reduction of cardiovascular risk.

      Once included in the study were applied to the following questionnaires to identify the stage
      of change according to the TM; Hospital Anxiety and Depression Scale (HAD) to evaluate the
      presence of anxiety and depression; 24-hours recall of multiple steps; Food consumption
      frequency to determine the quantity and quality of food intake and the Rapid Assessment
      Physical Activity Scale (RAPA), to determine the type, duration and intensity of physical
      activity of the subject. In addition, we measured weight, height, waist circumference, hip,
      and blood pressure.

      Finally were described and analyzed each of the variables according to the visits in which
      patients were cited.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Weight
time frame: 3 months
description: Weight loss
arm group label: Control group
arm group type: No Intervention
description: The control group comprised 41 patients, which was to go once a month to receive nutritional intervention with the prescription of a hypocaloric diet on the part of the nutritionist. The control group had a monthly monitoring for 3 months.
arm group label: Intervention group
arm group type: Experimental
description: The intervention group made up of 42 patients using the transtheoretical model and MI through sessions group and sessions individual with topics of healthy eating habits taught by a nutritionist, physical activity and exercise manual taught by a physical therapist, preparation of healthy food with menu taught by graduates in gastronomy and confrontation of barriers given by a psychologist. The intervention group had a monthly monitoring for 3 months. The diet that was prescribed to the intervention group was with the characteristics of the DASH diet.
intervention type: Behavioral
intervention name: The Transtheoretical Model
description: Intervention with the Transtheoretical Model, through group and individual sessions with topics of healthy eating habits taught by a dietician, physical activity and exercise manual taught by a physical therapist, preparation of healthy food with menu taught by graduates in gastronomy, confrontation of barriers given by a psychologist. This group had a monthly monitoring during 3 months. The food plan that was prescribed to the intervention group was with the characteristics of the DASH diet, according to the most recent international guides of the ACC and AHA, for the reduction of cardiovascular risk.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
investigator full name: LILIA CASTILLO MARTINEz
investigator title: Professor
sharing ipd: No