<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/NCT01729936</url>
  </required_header>
  <id_info>
    <org_study_id>PI11/01082</org_study_id>
    <nct_id>NCT01729936</nct_id>
  </id_info>
  <brief_title>SedestActiv Project: Intervention to Reduce Diary Hours of Sitting Time in Overweight and Obese Patients</brief_title>
  <acronym>SedestActiv</acronym>
  <official_title>Effectiveness of an Intervention to Reduce Diary Hours of Sitting Time in Overweight and Obese Patients (SEDESACTIV):Simple Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto de Salud Carlos III</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fondo de Investigacion Sanitaria</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Preventive Services and Health Promotion Research Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary care centres are a key setting to treat people with overweight and moderate obesity.&#xD;
      There is growing evidence that sitting for a long time is negatively associated with people's&#xD;
      health. Interventions with the aim of reducing daily time of sedentary activities can be an&#xD;
      effective strategy to increase daily energy expenditure. To improve the effectiveness of&#xD;
      programmes promoting physical activity in primary care we need some clear action protocols&#xD;
      that can be easily integrated in the daily routines of primary care professionals.&#xD;
&#xD;
      Objective. The objective of the study is to evaluate the effectiveness of a six-moth primary&#xD;
      care intervention to reduce diary hours of sitting time in overweight and obese sedentary&#xD;
      patients, as well as to increase their weekly caloric spend.&#xD;
&#xD;
      Methods. The design of the study is a simple randomized controlled trial. Ten primary care&#xD;
      centers will be invited to participate and will be randomized into control (CG) and&#xD;
      intervention group (IG). Each professional will randomly invite to participate voluntarily&#xD;
      moderate obese or overweight patients (BMI: 25-34,9 kg/m2) of both sexes, aged between 25 and&#xD;
      65 years old, who are 6 or more than 6 hours daily sitting. A total of 400 subjects (200&#xD;
      individuals in each group) are needed. In addition, 50 subjects with fibromyalgia will be&#xD;
      included in the study to know the feasibility of the intervention among them.&#xD;
&#xD;
      The main dependent variable (sitting times) will be measured with an ActivPAL during first&#xD;
      and last intervention week. There will be a follow up after 3, 6 and 12 months of the end of&#xD;
      the intervention. Other variables included in the study: number of steps walked, subjective&#xD;
      level of physical activity, weight, height, BMI, skinfolds, waist circumference,&#xD;
      triglycerides, total cholesterol, (LDL and HDL), glucose, sociodemographic variables, blood&#xD;
      pressure and quality of life related to health. A descriptive analysis of all variables and a&#xD;
      multivariate analysis to assess differences among intervention and control group will be&#xD;
      undertaken. Multivariate analysis will be carried out to assess time changes of dependent&#xD;
      variables. All the analysis will be done under the intention to treat principle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention will be based on a recommendation to find alternatives to progressively&#xD;
      substitute Sitting time by doing the regular activities standing or walking. Control group&#xD;
      will receive minimum advice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2012</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">February 2014</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>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To assess the effectiveness of a 6-month primary care intervention to reduce diary hours of Sitting time in overweight and obese patients, as well as to increase their weekly caloric spend</measure>
    <time_frame>Baseline-6-9-12 and 18 month</time_frame>
    <description>In this part of the study will use two measure tools: 1) A sitting time test during a working day and during the weekends (Marshall Test). 2) The activPal device will measure the sitting, stand and walking minutes and Mets expended during a week period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of steps walked</measure>
    <time_frame>Baseline-6-9-12 and 18 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective level of physical activity</measure>
    <time_frame>Baseline-6-9-12 and 18 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life related to health</measure>
    <time_frame>Baseline-6-9-12 and 18 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Baseline-6-9-12 and 18 month</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Skinfolds and waist circumference</measure>
    <time_frame>Baseline-6-9-12 and 18 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Triglycerides, total cholesterol and glucose</measure>
    <time_frame>Baseline-6-9-12 and 18 month</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Overweight</condition>
  <condition>Obese</condition>
  <condition>Sedentary</condition>
  <arm_group>
    <arm_group_label>Sitting time Change Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sitting time Change Intervention: recommendation to substitute Sitting time by doing the regular activities standing or walking.&#xD;
Duration: 6 month. Frequency: 1 time each 15 days during the first 4 month and 1 time each month the last 2 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control visits to the Primary Health Care Center</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sitting time Change Intervention</intervention_name>
    <description>Intervention to find alternatives to substitute sitting time by doing the regular activities standing or walking.</description>
    <arm_group_label>Sitting time Change Intervention</arm_group_label>
    <other_name>SedestActiv Intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Overweight and moderate obese patients (BMI: 25-34,9 kg/m2).&#xD;
&#xD;
          -  Be 6 or more than 6 hours daily sitting.&#xD;
&#xD;
          -  Able to walk and stand up from a chair unaided.&#xD;
&#xD;
          -  Subjects who can guarantee a year continuity in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recommended contradictions to advising physical activity to overweight and obese&#xD;
             people.&#xD;
&#xD;
          -  Have an obesity surgical operation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martínez R Elena</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Català de la Salut</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IDIAP Jordi Gol</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carme Martín-Borràs</last_name>
      <email>sedestactiv@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>August 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>February 7, 2014</last_update_submitted>
  <last_update_submitted_qc>February 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sitting time</keyword>
  <keyword>Overweight</keyword>
  <keyword>Obese</keyword>
  <keyword>Primary Health Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</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/NCT01729936
org study id: PI11/01082
nct id: NCT01729936
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Primary care centres are a key setting to treat people with overweight and moderate obesity.
      There is growing evidence that sitting for a long time is negatively associated with people's
      health. Interventions with the aim of reducing daily time of sedentary activities can be an
      effective strategy to increase daily energy expenditure. To improve the effectiveness of
      programmes promoting physical activity in primary care we need some clear action protocols
      that can be easily integrated in the daily routines of primary care professionals.

      Objective. The objective of the study is to evaluate the effectiveness of a six-moth primary
      care intervention to reduce diary hours of sitting time in overweight and obese sedentary
      patients, as well as to increase their weekly caloric spend.

      Methods. The design of the study is a simple randomized controlled trial. Ten primary care
      centers will be invited to participate and will be randomized into control (CG) and
      intervention group (IG). Each professional will randomly invite to participate voluntarily
      moderate obese or overweight patients (BMI: 25-34,9 kg/m2) of both sexes, aged between 25 and
      65 years old, who are 6 or more than 6 hours daily sitting. A total of 400 subjects (200
      individuals in each group) are needed. In addition, 50 subjects with fibromyalgia will be
      included in the study to know the feasibility of the intervention among them.

      The main dependent variable (sitting times) will be measured with an ActivPAL during first
      and last intervention week. There will be a follow up after 3, 6 and 12 months of the end of
      the intervention. Other variables included in the study: number of steps walked, subjective
      level of physical activity, weight, height, BMI, skinfolds, waist circumference,
      triglycerides, total cholesterol, (LDL and HDL), glucose, sociodemographic variables, blood
      pressure and quality of life related to health. A descriptive analysis of all variables and a
      multivariate analysis to assess differences among intervention and control group will be
      undertaken. Multivariate analysis will be carried out to assess time changes of dependent
      variables. All the analysis will be done under the intention to treat principle.
The intervention will be based on a recommendation to find alternatives to progressively
      substitute Sitting time by doing the regular activities standing or walking. Control group
      will receive minimum advice.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: To assess the effectiveness of a 6-month primary care intervention to reduce diary hours of Sitting time in overweight and obese patients, as well as to increase their weekly caloric spend
time frame: Baseline-6-9-12 and 18 month
description: In this part of the study will use two measure tools: 1) A sitting time test during a working day and during the weekends (Marshall Test). 2) The activPal device will measure the sitting, stand and walking minutes and Mets expended during a week period.
measure: Number of steps walked
time frame: Baseline-6-9-12 and 18 month
measure: Subjective level of physical activity
time frame: Baseline-6-9-12 and 18 month
measure: Quality of life related to health
time frame: Baseline-6-9-12 and 18 month
measure: Blood pressure
time frame: Baseline-6-9-12 and 18 month
measure: Skinfolds and waist circumference
time frame: Baseline-6-9-12 and 18 month
measure: Triglycerides, total cholesterol and glucose
time frame: Baseline-6-9-12 and 18 month
arm group label: Sitting time Change Intervention
arm group type: Experimental
description: Sitting time Change Intervention: recommendation to substitute Sitting time by doing the regular activities standing or walking.
Duration: 6 month. Frequency: 1 time each 15 days during the first 4 month and 1 time each month the last 2 months.
arm group label: Active Control
arm group type: No Intervention
description: Control visits to the Primary Health Care Center
intervention type: Behavioral
intervention name: Sitting time Change Intervention
description: Intervention to find alternatives to substitute sitting time by doing the regular activities standing or walking.
arm group label: Sitting time Change Intervention
other name: SedestActiv Intervention
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: No
last name: Martínez R Elena
role: Principal Investigator
affiliation: Institut Català de la Salut
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Sponsor
mesh term: Overweight