<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/NCT03749291</url>
  </required_header>
  <id_info>
    <org_study_id>PI18/00226</org_study_id>
    <nct_id>NCT03749291</nct_id>
  </id_info>
  <brief_title>Motivational Intervention on the Gut Microbiota of Obese Children</brief_title>
  <acronym>MICROBEkids</acronym>
  <official_title>Effect of a Motivational Intervention on the Gut Microbiota and the Components of the Metabolic Syndrome in a Population of Obese Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Investigacio Sanitaria Pere Virgili</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Universitari Joan XXIII de Tarragona.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Universitari Sant Joan de Reus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Rovira i Virgili</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut Investigacio Sanitaria Pere Virgili</source>
  <oversight_info>
    <has_dmc>No</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>
      Animal models and studies on small samples of obese adults have shown that gut microbial&#xD;
      diversity and certain types of bacteria could predict the efficacy of the dietetic treatment&#xD;
      to improve body mass index (BMI) and the components of metabolic syndrome (MetS). Gut&#xD;
      microbiota could distinguish the obese with metabolic syndrome patient than that&#xD;
      metabolically healthy. Dietetic therapy could induce changes in the microbiota that could&#xD;
      lead to improvement of BMI and the components of the MetS. The aim of MICROBEkids is to test&#xD;
      whether the motivational intervention a motivational intervention (OBEMAT2.0) (PI15/00970) is&#xD;
      more effective than the conventional intervention to increase the gut microbial diversity&#xD;
      and, as a consequence, to improve BMI and MetS components. The role of gut microbiota&#xD;
      (through modulation of the short chain fatty acids) will be analyzed as cardiovascular risk&#xD;
      factor and as predictor of treatment success. These objectives will be achieved through a&#xD;
      clustered clinical trial design with an intervention group that will receive a motivational&#xD;
      therapy compared to a control group that will receive a conventional intervention, both&#xD;
      during 12 months. The study sample are 319 children (n= 167 in the intervention group) that&#xD;
      were enrolled in the clinical trial OBEMAT2.0 (PI15/00970), have had a comprehensive clinical&#xD;
      assessment before the intervention (ages 8 to 14) and after 12 months (+3) of therapy (ages 9&#xD;
      to 15) and furthermore have participated in a biological samples collection for the&#xD;
      investigation on childhood obesity (COLOBEPED, reference C.0004585).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will provide light to several hypothesis:&#xD;
&#xD;
      - The main hypothesis is that the dietetic intervention in obese children may improve the&#xD;
      components of the metabolic syndrome by mediation (at least in part) of changes in the&#xD;
      microbiota.&#xD;
&#xD;
      Other secondary hypothesis to be demonstrated are:&#xD;
&#xD;
        -  The microbiota (before the treatment) could be a determinant factor of the metabolic&#xD;
           syndrome (inflamation, serum lipid profile, insulin resistance) being a key feature&#xD;
           differentiating the metabolically healthy obese from the obese with metabolic syndrome.&#xD;
&#xD;
        -  A dietary pattern rich in vegetables and fruits is associated to a gut microbiota&#xD;
           profile preventing the metabolic syndrome&#xD;
&#xD;
      How these hypothesis will be demonstrated? A motivational structured intervention to reduce&#xD;
      weight is applied (under randomized clustered design) to obese children, that are compared to&#xD;
      an active intervention (not structured) provided by health care professionals, both groups&#xD;
      during 12 months (+3).&#xD;
&#xD;
      A baseline and final assessment (before and after the intervention) are performed, in which&#xD;
      the following information is collected:&#xD;
&#xD;
        -  Socioeconomics&#xD;
&#xD;
        -  Anthropometry (weight, height, waist circumference) to calculate the obesity degree (BMI&#xD;
           z- score) and the presence of abdominal obesity&#xD;
&#xD;
        -  Body composition: deuterium dilution (in a subsample), bioimpedance, Dual X-Ray&#xD;
           Absorptiometry and Air displacement pletismography (BodPod)&#xD;
&#xD;
        -  Blood sample drawn: to analyze lipids profile and insulin resistance&#xD;
&#xD;
        -  Fecal sample: the gut microbiota diversity and the presence of specific bacteria will be&#xD;
           analyzed&#xD;
&#xD;
        -  Dietary intake by a food frequency questionnaire: diet will be analyzed as dietary&#xD;
           patterns&#xD;
&#xD;
        -  Systolic and diastolic blood pressure (which will be adjusted as z-score)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>Fecal microbial diversity (diversity index like Gini-Simpson)</measure>
    <time_frame>12 (+3) months</time_frame>
    <description>Effect of the intervention on increments of Fecal microbial diversity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fecal Short Chain Fatty Acids: butyrate acid (μg)</measure>
    <time_frame>12 (+3) months</time_frame>
    <description>Effect of the intervention and microbiota on increments Short Chain Fatty Acids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal Short Chain Fatty Acids: acetic acid (μg)</measure>
    <time_frame>12 (+3) months</time_frame>
    <description>Effect of the intervention and microbiota on increments Short Chain Fatty Acids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal Short Chain Fatty Acids: propionic acid (μg)</measure>
    <time_frame>12 (+3) months</time_frame>
    <description>Effect of the intervention and microbiota on increments Short Chain Fatty Acids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Akkermansia Muciniphila (cfu)</measure>
    <time_frame>12 (+3) months</time_frame>
    <description>Effect of the intervention on increments of Akkermansia Muciniphila in feces</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">319</enrollment>
  <condition>Microbial Colonization</condition>
  <arm_group>
    <arm_group_label>Obemat2.0 Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Obese children (BMI &gt;97th percentile of the Spanish curves from Hernández 1988) Ages: 8 to 13 at baseline (9 to 15y at the end of the intervention)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Obese children (BMI &gt;97th percentile of the Spanish curves from Hernández 1988) Ages: 8 to 13 at baseline (9 to 15y at the end of the intervention)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Obemat2.0 therapy</intervention_name>
    <description>Lifestyle (diet &amp; physical activity) structured recommendations through a motivational interview.&#xD;
Duration: 12(+3) months Description: 1 visit/month &amp; 3 Workshops in primary care centers Providers: pediatricians and nurses trained to perform motivational interview The interviews are structured as follows: First, checking the accomplishment of objectives to motivate the participant. Second, a specific topic per visit is explained to the participant. Third, a task related to the topic (i.e. to plan a weekly menu for the family) is given to be brought back at the next visit. 4th. Objectives about diet, weight &amp; physical activity are defined to be accomplished until the next visit.</description>
    <arm_group_label>Obemat2.0 Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Clinical Practice</intervention_name>
    <description>Lifestyle (diet and physical activity) Duration: 12 (+3) months Description: 1visit/month to the primary care centers. Providers: pediatricians &amp; nurses. Children assigned to the control group receive the usual treatment conducted in primary care centers based on the Clinical Practice Guidelines on the Prevention and Treatment of Child and Adolescent Obesity [Spanish Ministry of Science and Innovation], 2009). At visits, the family receive recommendations to carry out a balanced diet, to provide a moderate energy reduction from the previous intake. An increase in physical activity, both in terms of leisure activity, as sports is advised.</description>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>Usual Reccomendations given at the pediatric consultations</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age range between 8 and &lt;14 years at enrolment (so that, children would end the&#xD;
             treatment at maximum age of 15 years&#xD;
&#xD;
          -  BMI &gt; 97th percentile of Hernandez references from 1988 (Hernández et al., 1988) as&#xD;
             indicated by the Guidelines for Clinical Practice of the Spanish Health System (Grupo&#xD;
             de trabajo de la Guía de Práctica Clínica sobre la Prevención y el Tratamiento de la&#xD;
             Obesidad Infantojuvenil. Ministerio de Ciencia e Innovación [Spanish Ministry of&#xD;
             Sciencee and Innovation], 2009) for the diagnose of the childhood obesity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with eating disorders&#xD;
&#xD;
          -  Families not available to attend to scheduled visits&#xD;
&#xD;
          -  Simultaneous participation in another clinical trial&#xD;
&#xD;
          -  Presence of endocrine disorders (GH disorder, hypothyroidism, Cushing's disease, early&#xD;
             puberty or other)&#xD;
&#xD;
          -  Lack of command of local languages&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Veronica Luque</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut d'Investigació Sanitària Pere Virgili</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine, C/ Sant Llorenç 21</name>
      <address>
        <city>Reus</city>
        <state>Tarragona</state>
        <zip>43201</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iispv- Hospital Sant Joan de Reus</name>
      <address>
        <city>Reus</city>
        <state>Tarragona</state>
        <zip>E43204</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Tarragona Joan XXIII</name>
      <address>
        <city>Tarragona</city>
        <zip>43005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>October 8, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>September 15, 2020</last_update_submitted>
  <last_update_submitted_qc>September 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institut Investigacio Sanitaria Pere Virgili</investigator_affiliation>
    <investigator_full_name>Veronica Luque</investigator_full_name>
    <investigator_title>Dr. PhD</investigator_title>
  </responsible_party>
  <keyword>Childhood Obesity</keyword>
  <keyword>Motivational therapy</keyword>
  <keyword>Dietary Patterns</keyword>
  <keyword>Cardiovascular disease risk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <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/NCT03749291
org study id: PI18/00226
nct id: NCT03749291
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Animal models and studies on small samples of obese adults have shown that gut microbial
      diversity and certain types of bacteria could predict the efficacy of the dietetic treatment
      to improve body mass index (BMI) and the components of metabolic syndrome (MetS). Gut
      microbiota could distinguish the obese with metabolic syndrome patient than that
      metabolically healthy. Dietetic therapy could induce changes in the microbiota that could
      lead to improvement of BMI and the components of the MetS. The aim of MICROBEkids is to test
      whether the motivational intervention a motivational intervention (OBEMAT2.0) (PI15/00970) is
      more effective than the conventional intervention to increase the gut microbial diversity
      and, as a consequence, to improve BMI and MetS components. The role of gut microbiota
      (through modulation of the short chain fatty acids) will be analyzed as cardiovascular risk
      factor and as predictor of treatment success. These objectives will be achieved through a
      clustered clinical trial design with an intervention group that will receive a motivational
      therapy compared to a control group that will receive a conventional intervention, both
      during 12 months. The study sample are 319 children (n= 167 in the intervention group) that
      were enrolled in the clinical trial OBEMAT2.0 (PI15/00970), have had a comprehensive clinical
      assessment before the intervention (ages 8 to 14) and after 12 months (+3) of therapy (ages 9
      to 15) and furthermore have participated in a biological samples collection for the
      investigation on childhood obesity (COLOBEPED, reference C.0004585).
The study will provide light to several hypothesis:

      - The main hypothesis is that the dietetic intervention in obese children may improve the
      components of the metabolic syndrome by mediation (at least in part) of changes in the
      microbiota.

      Other secondary hypothesis to be demonstrated are:

        -  The microbiota (before the treatment) could be a determinant factor of the metabolic
           syndrome (inflamation, serum lipid profile, insulin resistance) being a key feature
           differentiating the metabolically healthy obese from the obese with metabolic syndrome.

        -  A dietary pattern rich in vegetables and fruits is associated to a gut microbiota
           profile preventing the metabolic syndrome

      How these hypothesis will be demonstrated? A motivational structured intervention to reduce
      weight is applied (under randomized clustered design) to obese children, that are compared to
      an active intervention (not structured) provided by health care professionals, both groups
      during 12 months (+3).

      A baseline and final assessment (before and after the intervention) are performed, in which
      the following information is collected:

        -  Socioeconomics

        -  Anthropometry (weight, height, waist circumference) to calculate the obesity degree (BMI
           z- score) and the presence of abdominal obesity

        -  Body composition: deuterium dilution (in a subsample), bioimpedance, Dual X-Ray
           Absorptiometry and Air displacement pletismography (BodPod)

        -  Blood sample drawn: to analyze lipids profile and insulin resistance

        -  Fecal sample: the gut microbiota diversity and the presence of specific bacteria will be
           analyzed

        -  Dietary intake by a food frequency questionnaire: diet will be analyzed as dietary
           patterns

        -  Systolic and diastolic blood pressure (which will be adjusted as z-score)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Fecal microbial diversity (diversity index like Gini-Simpson)
time frame: 12 (+3) months
description: Effect of the intervention on increments of Fecal microbial diversity
measure: Fecal Short Chain Fatty Acids: butyrate acid (μg)
time frame: 12 (+3) months
description: Effect of the intervention and microbiota on increments Short Chain Fatty Acids
measure: Fecal Short Chain Fatty Acids: acetic acid (μg)
time frame: 12 (+3) months
description: Effect of the intervention and microbiota on increments Short Chain Fatty Acids
measure: Fecal Short Chain Fatty Acids: propionic acid (μg)
time frame: 12 (+3) months
description: Effect of the intervention and microbiota on increments Short Chain Fatty Acids
measure: Akkermansia Muciniphila (cfu)
time frame: 12 (+3) months
description: Effect of the intervention on increments of Akkermansia Muciniphila in feces
arm group label: Obemat2.0 Intervention Group
arm group type: Experimental
description: Obese children (BMI >97th percentile of the Spanish curves from Hernández 1988) Ages: 8 to 13 at baseline (9 to 15y at the end of the intervention)
arm group label: Control Group
arm group type: Active Comparator
description: Obese children (BMI >97th percentile of the Spanish curves from Hernández 1988) Ages: 8 to 13 at baseline (9 to 15y at the end of the intervention)
intervention type: Other
intervention name: Obemat2.0 therapy
description: Lifestyle (diet & physical activity) structured recommendations through a motivational interview.
Duration: 12(+3) months Description: 1 visit/month & 3 Workshops in primary care centers Providers: pediatricians and nurses trained to perform motivational interview The interviews are structured as follows: First, checking the accomplishment of objectives to motivate the participant. Second, a specific topic per visit is explained to the participant. Third, a task related to the topic (i.e. to plan a weekly menu for the family) is given to be brought back at the next visit. 4th. Objectives about diet, weight & physical activity are defined to be accomplished until the next visit.
arm group label: Obemat2.0 Intervention Group
intervention type: Other
intervention name: Usual Clinical Practice
description: Lifestyle (diet and physical activity) Duration: 12 (+3) months Description: 1visit/month to the primary care centers. Providers: pediatricians & nurses. Children assigned to the control group receive the usual treatment conducted in primary care centers based on the Clinical Practice Guidelines on the Prevention and Treatment of Child and Adolescent Obesity [Spanish Ministry of Science and Innovation], 2009). At visits, the family receive recommendations to carry out a balanced diet, to provide a moderate energy reduction from the previous intake. An increase in physical activity, both in terms of leisure activity, as sports is advised.
arm group label: Control Group
other name: Usual Reccomendations given at the pediatric consultations
criteria: 
gender: All
minimum age: 8 Years
maximum age: 15 Years
healthy volunteers: No
last name: Veronica Luque
role: Principal Investigator
affiliation: Institut d'Investigació Sanitària Pere Virgili
facility: 
facility: 
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Institut Investigacio Sanitaria Pere Virgili
investigator full name: Veronica Luque
investigator title: Dr. PhD
mesh term: Communicable Diseases
mesh term: Infections
sharing ipd: No