<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/NCT03749200</url>
  </required_header>
  <id_info>
    <org_study_id>PI15/00970</org_study_id>
    <nct_id>NCT03749200</nct_id>
  </id_info>
  <brief_title>Motivational Approach to Treat Childhood Obesity</brief_title>
  <acronym>OBEMAT20</acronym>
  <official_title>Clinical and Metabolic Efficacy of the Motivational Approach, Coordinated Between Primary Care and the Clinical Health Services for Childhood Obesity Treatment: Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Investigacio Sanitaria Pere Virgili</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut Català de la Salut</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <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>Instituto de Salud Carlos III</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The treatment of childhood obesity is challenging. Although dietary and physical activity&#xD;
      recommendations are widely known, the willingness to change lifestyles within the family is&#xD;
      not easy to be achieved. Motivational interviewing has been shown as a possibly effective&#xD;
      method to increase adherence to dietary recommendations in the obese adult.&#xD;
&#xD;
      There is scarce evidence showing whether implementing a motivational interview in obese&#xD;
      children could be effective.&#xD;
&#xD;
      The aim of this clinical trial is assessing the effect of a motivational interview,&#xD;
      coordinated between the clinical and primary care services on 8 to 14 years old obese&#xD;
      children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In a recent study, the investigators have demonstrated that the motivational therapy approach&#xD;
      to treat childhood obesity is highly effective at clinical and metabolic levels. This&#xD;
      efficacy has been proved in a clinical outpatient setting. However, a standardized&#xD;
      collaborative approach between the clinic and the primary care services would allow a faster&#xD;
      and easier approach to childhood obesity treatment. Furthermore, this motivational and&#xD;
      educational intervention would benefit from the current technologic facilities, the long term&#xD;
      effect of the education at group level, in terms of food shopping plan, healthy, fast and&#xD;
      easy cooking methods.&#xD;
&#xD;
      The aim of this clinical trial is to test the efficacy of a multicomponent motivational&#xD;
      intervention for the treatment of childhood obesity, coordinated between primary care and&#xD;
      hospital specialized services, integrating motivational individual interviews, educational&#xD;
      groups and eHealth tools (wearable), compared to the usual intervention performed in&#xD;
      paediatrics.&#xD;
&#xD;
      The design will be a clustered randomized control trial, with an intervention group that will&#xD;
      receive a multicomponent motivational and educational plan which will be compared to a&#xD;
      control group receiving the usual recommendations performed in primary care centres (n=167&#xD;
      per group). The treatment of both study groups will last 12 months and will be performed at&#xD;
      the primary care centres. In parallel, the study team will validate the methodology used to&#xD;
      assess body composition in obese children as well as the changes produced by the&#xD;
      intervention.&#xD;
&#xD;
      Children assigned to the control group receive advices as recommended by the Clinical&#xD;
      Practice Guidelines (17). At visits, the family receive explanations about carrying out a&#xD;
      balanced diet, divided into 5 meals, in order to provide a moderate energy intake reduction.&#xD;
      An increase in physical activity, both in terms of leisure activity, as sports regular&#xD;
      practise are recommended. Monthly visits are organized in which weight and height are&#xD;
      measured, and compliance with recommendations are actually taking place.&#xD;
&#xD;
      Children assigned to the intervention group receive similar recommendations to those in the&#xD;
      control group but under a motivational interview schema. This means that each visit,&#xD;
      objectives from the last visit are fulfiled, the therapists try to make the family&#xD;
      recongnizing the changes to be done by themselves, rather than imposing by demonstrating&#xD;
      ambivalences, and objectives for the next visit are agreed. Furthermore, three workshops as&#xD;
      group therapy are organized with the following topics: 1. Increasing physical actty sing an&#xD;
      eHEalth monitor, 2. Food choices and dietary balance, and 3. Cooking methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</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>
    <intervention_model_description>Randomized clustered clinical trial, with treatment on obese children in 2 arms: a control group (CG) that will follow the usual recommendations of pediatricians and nurses in the primary care centres and an intervention group (IG) that will receive a structured motivation-based interview combined with group therapy and eHealth. the treatment of the two arms will last 12 (+3) months</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Given the nature of the intervention participants or researchers could not be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Body Mass Index z-score</measure>
    <time_frame>12 (+3) months</time_frame>
    <description>Changes in BMI z-score between the baseline visit and the final assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Abdominal obesity (waist circumference)</measure>
    <time_frame>12 (+3) months</time_frame>
    <description>Changes in waist circumference (cm) between the baseline visit and the final assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abdominal obesity (waist to height)</measure>
    <time_frame>12 (+3) months</time_frame>
    <description>Changes in waist-to-height circumference (ratio) between the baseline visit and the final assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition: fat mass (kg)</measure>
    <time_frame>12 (+3) months</time_frame>
    <description>Changes in fat mass (kg) between the baseline visit and the final assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition: lean mass (kg)</measure>
    <time_frame>12 (+3) months</time_frame>
    <description>Changes in lean mass (kg) between the baseline visit and the final assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition: fat mass index (kg/m2)</measure>
    <time_frame>12 (+3) months</time_frame>
    <description>Changes in fat mass index between the baseline visit and the final assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition: lean mass index (kg/m2)</measure>
    <time_frame>12 (+3) months</time_frame>
    <description>Changes in lean mass index between the baseline visit and the final assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HOMA-IR</measure>
    <time_frame>12 (+3) months</time_frame>
    <description>Changes in insulin resistance between the baseline visit and the final assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>12 (+3) months</time_frame>
    <description>Changes in systolic and diastoli blood pressure (s-score) between the baseline visit and the final assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tryglycerides</measure>
    <time_frame>12 (+3) months</time_frame>
    <description>Changes in tryglycerides (mg/dl) between the baseline visit and the final assessment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">319</enrollment>
  <condition>Childhood Obesity</condition>
  <condition>Metabolic Syndrome</condition>
  <condition>Body Composition</condition>
  <arm_group>
    <arm_group_label>Obemat2.0 Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Obemat2.0 therapy (11 Motivational Interview Visits, 3 Workshops) Duration: 12 months (+3 months). Setting: Primary care centers Providers: pediatritians and nurses trained to perform motivational interview Visits description: The interviews follow a structure: 1. Checking the accomplishment of objectives to congratulate and motivate the patient. 2. A specific topic per visit is explained to the participant and family. 3. 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 and physical activity are defined to be accomplished until the next visit. The follow-up of the structure is ensured by means of a printed material that the therapists provide each visit to participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control Intervention: regular practise in primary care (11 individual monthly visits) Duration: 12 months (+3 months). Setting: Primary care centers. Providers: standard pediatritians and nurses Children and their families receive the usual recommendations conducted in primary care centers based on the Clinical Practice Guidelines on the Prevention and Treatment of Child and Adolescent Obesity. At visits, the family receive explanations about carrying out a balanced diet, divided into 5 meals, to provide a moderate energy reduction from the previous intake. An increase in physical activity, both in terms of leisure activity, as sports regular practise is recommended. Monthly visits are organized in which weight and height are measured and compliance with advice is reviewed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Obemat2.0 therapy</intervention_name>
    <arm_group_label>Obemat2.0 Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Regular practise in primary care</intervention_name>
    <arm_group_label>Control Group</arm_group_label>
  </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>
  <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>IDIAP Jordi Gol</name>
      <address>
        <city>Reus</city>
        <state>Tarragona</state>
        <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>June 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>Ricardo Closa</investigator_full_name>
    <investigator_title>Dr. PhD</investigator_title>
  </responsible_party>
  <keyword>Childhood Obesity</keyword>
  <keyword>Motivational therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Pediatric Obesity</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/NCT03749200
org study id: PI15/00970
nct id: NCT03749200
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The treatment of childhood obesity is challenging. Although dietary and physical activity
      recommendations are widely known, the willingness to change lifestyles within the family is
      not easy to be achieved. Motivational interviewing has been shown as a possibly effective
      method to increase adherence to dietary recommendations in the obese adult.

      There is scarce evidence showing whether implementing a motivational interview in obese
      children could be effective.

      The aim of this clinical trial is assessing the effect of a motivational interview,
      coordinated between the clinical and primary care services on 8 to 14 years old obese
      children.
In a recent study, the investigators have demonstrated that the motivational therapy approach
      to treat childhood obesity is highly effective at clinical and metabolic levels. This
      efficacy has been proved in a clinical outpatient setting. However, a standardized
      collaborative approach between the clinic and the primary care services would allow a faster
      and easier approach to childhood obesity treatment. Furthermore, this motivational and
      educational intervention would benefit from the current technologic facilities, the long term
      effect of the education at group level, in terms of food shopping plan, healthy, fast and
      easy cooking methods.

      The aim of this clinical trial is to test the efficacy of a multicomponent motivational
      intervention for the treatment of childhood obesity, coordinated between primary care and
      hospital specialized services, integrating motivational individual interviews, educational
      groups and eHealth tools (wearable), compared to the usual intervention performed in
      paediatrics.

      The design will be a clustered randomized control trial, with an intervention group that will
      receive a multicomponent motivational and educational plan which will be compared to a
      control group receiving the usual recommendations performed in primary care centres (n=167
      per group). The treatment of both study groups will last 12 months and will be performed at
      the primary care centres. In parallel, the study team will validate the methodology used to
      assess body composition in obese children as well as the changes produced by the
      intervention.

      Children assigned to the control group receive advices as recommended by the Clinical
      Practice Guidelines (17). At visits, the family receive explanations about carrying out a
      balanced diet, divided into 5 meals, in order to provide a moderate energy intake reduction.
      An increase in physical activity, both in terms of leisure activity, as sports regular
      practise are recommended. Monthly visits are organized in which weight and height are
      measured, and compliance with recommendations are actually taking place.

      Children assigned to the intervention group receive similar recommendations to those in the
      control group but under a motivational interview schema. This means that each visit,
      objectives from the last visit are fulfiled, the therapists try to make the family
      recongnizing the changes to be done by themselves, rather than imposing by demonstrating
      ambivalences, and objectives for the next visit are agreed. Furthermore, three workshops as
      group therapy are organized with the following topics: 1. Increasing physical actty sing an
      eHEalth monitor, 2. Food choices and dietary balance, and 3. Cooking methods.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized clustered clinical trial, with treatment on obese children in 2 arms: a control group (CG) that will follow the usual recommendations of pediatricians and nurses in the primary care centres and an intervention group (IG) that will receive a structured motivation-based interview combined with group therapy and eHealth. the treatment of the two arms will last 12 (+3) months
primary purpose: Treatment
masking: None (Open Label)
masking description: Given the nature of the intervention participants or researchers could not be blinded.
measure: Body Mass Index z-score
time frame: 12 (+3) months
description: Changes in BMI z-score between the baseline visit and the final assessment
measure: Abdominal obesity (waist circumference)
time frame: 12 (+3) months
description: Changes in waist circumference (cm) between the baseline visit and the final assessment
measure: Abdominal obesity (waist to height)
time frame: 12 (+3) months
description: Changes in waist-to-height circumference (ratio) between the baseline visit and the final assessment
measure: Body composition: fat mass (kg)
time frame: 12 (+3) months
description: Changes in fat mass (kg) between the baseline visit and the final assessment
measure: Body composition: lean mass (kg)
time frame: 12 (+3) months
description: Changes in lean mass (kg) between the baseline visit and the final assessment
measure: Body composition: fat mass index (kg/m2)
time frame: 12 (+3) months
description: Changes in fat mass index between the baseline visit and the final assessment
measure: Body composition: lean mass index (kg/m2)
time frame: 12 (+3) months
description: Changes in lean mass index between the baseline visit and the final assessment
measure: HOMA-IR
time frame: 12 (+3) months
description: Changes in insulin resistance between the baseline visit and the final assessment
measure: Blood Pressure
time frame: 12 (+3) months
description: Changes in systolic and diastoli blood pressure (s-score) between the baseline visit and the final assessment
measure: Tryglycerides
time frame: 12 (+3) months
description: Changes in tryglycerides (mg/dl) between the baseline visit and the final assessment
arm group label: Obemat2.0 Intervention Group
arm group type: Experimental
description: Intervention: Obemat2.0 therapy (11 Motivational Interview Visits, 3 Workshops) Duration: 12 months (+3 months). Setting: Primary care centers Providers: pediatritians and nurses trained to perform motivational interview Visits description: The interviews follow a structure: 1. Checking the accomplishment of objectives to congratulate and motivate the patient. 2. A specific topic per visit is explained to the participant and family. 3. 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 and physical activity are defined to be accomplished until the next visit. The follow-up of the structure is ensured by means of a printed material that the therapists provide each visit to participants.
arm group label: Control Group
arm group type: Active Comparator
description: Control Intervention: regular practise in primary care (11 individual monthly visits) Duration: 12 months (+3 months). Setting: Primary care centers. Providers: standard pediatritians and nurses Children and their families receive the usual recommendations conducted in primary care centers based on the Clinical Practice Guidelines on the Prevention and Treatment of Child and Adolescent Obesity. At visits, the family receive explanations about carrying out a balanced diet, divided into 5 meals, to provide a moderate energy reduction from the previous intake. An increase in physical activity, both in terms of leisure activity, as sports regular practise is recommended. Monthly visits are organized in which weight and height are measured and compliance with advice is reviewed.
intervention type: Other
intervention name: Obemat2.0 therapy
arm group label: Obemat2.0 Intervention Group
intervention type: Other
intervention name: Regular practise in primary care
arm group label: Control Group
criteria: 
gender: All
minimum age: 8 Years
maximum age: 15 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Institut Investigacio Sanitaria Pere Virgili
investigator full name: Ricardo Closa
investigator title: Dr. PhD
mesh term: Obesity
mesh term: Metabolic Syndrome
mesh term: Pediatric Obesity
sharing ipd: No