<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/NCT03306069</url>
  </required_header>
  <id_info>
    <org_study_id>BELITA-Study</org_study_id>
    <nct_id>NCT03306069</nct_id>
  </id_info>
  <brief_title>Effects of Low-volume Aerobic Interval Training in Overweight Individuals at Increased Cardiometabolic Risk</brief_title>
  <acronym>BELITA</acronym>
  <official_title>Low-volume Aerobic Interval Training in Overweight Individuals at Increased Cardiometabolic Risk: Impact of Training Intensity on Cardiorespiratory Fitness, Cardiometabolic Risk Profile and Exercise Adherence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Erlangen-Nürnberg Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Erlangen-Nürnberg Medical School</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to compare the impact of aerobic interval training&#xD;
      intensity on exercise adherence and changes in cardiorespiratory fitness, cardiometabolic&#xD;
      risk profile, body composition, inflammatory markers and subjective health outcomes after a&#xD;
      12-week intervention trial in overweight individuals at increased cardiometabolic risk.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">April 15, 2020</completion_date>
  <primary_completion_date type="Actual">February 15, 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>Parallel Assignment parallel-group, randomized-controlled study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcome Assessors involved in data analysis will not be aware of the arm to which the participants were allocated (single-blinded masking).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiorespiratory Fitness (CRF)</measure>
    <time_frame>12 weeks (baseline to 12 week follow-up assessment)</time_frame>
    <description>CRF will be assessed by measuring Maximum Oxygen uptake (VO2max)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Metabolic Syndrome Z-Score (MetS-Z-Score)</measure>
    <time_frame>12 weeks (baseline to 12 week follow-up assessment)</time_frame>
    <description>MetS-Z-Score will be calculated from each individual's measures of waist circumference, mean arterial blood pressure, triglycerides, and HDL-cholesterol, based on equations specific to sex.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>12 weeks (baseline to 12 week follow-up assessment)</time_frame>
    <description>Muscle mass, fat mass and body water will be measured by Bioelectrical Impedance Analysis (BIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin sensitivity</measure>
    <time_frame>12 weeks (baseline to 12 week follow-up assessment)</time_frame>
    <description>Insulin sensitivity will be estimated using homeostasis model assessment index (HOMA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation</measure>
    <time_frame>12 weeks (baseline to 12 week follow-up assessment)</time_frame>
    <description>Inflammation will be assessed by measuring levels of inflammatory blood markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>12 weeks (baseline to 12 week follow-up assessment)</time_frame>
    <description>Health-related quality of life will be assessed by using the standardized and validated EQ-5D-5L Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain scores</measure>
    <time_frame>12 weeks (baseline to 12 week follow-up assessment)</time_frame>
    <description>Pain scores will be assessed by using the standardized and validated Chronic Pain Grade Questionnaire (CPGQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived stress</measure>
    <time_frame>12 weeks (baseline to 12 week follow-up assessment)</time_frame>
    <description>Perceived stress will be assessed by using the standardized and validated Perceived Stress Questionnaire (PSQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective work ability</measure>
    <time_frame>12 weeks (baseline to 12 week follow-up assessment)</time_frame>
    <description>Subjective work ability will be assessed by using the standardized and validated Work Ability Index Questionnaire (WAI)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">154</enrollment>
  <condition>Overweight and Obesity</condition>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nutritional therapy / no exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HIIT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High-intensity interval training (HIIT) at 90% heart rate maximum (HRmax) combined with Nutritional therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MIIT-HR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Heart rate based moderate-intensity interval training (MIIT-HR) at 70% heart rate maximum (HRmax) combined with Nutritional therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MIIT-LT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lactate threshold based moderate-intensity interval training (MIIT-LT) at 105% of lactate threshold (corresponding ~70-75% HRmax) combined with Nutritional therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Individualized, weight-reducing nutritional therapy and counseling, during a study period of 12 weeks</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HIIT</intervention_name>
    <description>Procedures: Nutritional therapy (individualized, weightreducing nutritional therapy and counseling) during a study period of 12 weeks combined with supervised ergometer-based high-intensity interval training (HIIT).&#xD;
HIIT:&#xD;
2 sessions per week&#xD;
5x1 min at 80-95% HRmax&#xD;
time-effort per week: ~30 min</description>
    <arm_group_label>HIIT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MIIT-HR</intervention_name>
    <description>Procedures: Nutritional therapy (individualized, weightreducing nutritional therapy and counseling) during a study period of 12 weeks combined with supervised ergometer-based moderate-intensity interval training on the basis of HRmax (MIIT-HR).&#xD;
MIIT-HR:&#xD;
2 sessions per week&#xD;
5x1 min at 65-79% HRmax&#xD;
time-effort per week: ~30 min</description>
    <arm_group_label>MIIT-HR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MIIT-LT</intervention_name>
    <description>Procedures: Nutritional therapy (individualized, weightreducing nutritional therapy and counseling) during a study period of 12 weeks combined with supervised ergometer-based moderate-intensity interval training on the basis of lactate threshold (MIIT-LT).&#xD;
MIIT-LT:&#xD;
2 sessions per week&#xD;
session 1: 2x4 min / session 2: 5x1 min, each at 105% LT&#xD;
time-effort per week: ~30 min</description>
    <arm_group_label>MIIT-LT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index &gt;/=30&#xD;
&#xD;
          -  presence of at least 2 cardiometabolic risk factors&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Healthy persons or patients under age&#xD;
&#xD;
          -  Overweight persons without any additional cardiometabolic risk factors&#xD;
&#xD;
          -  Pregnancy, Lactation&#xD;
&#xD;
          -  Psychological disorders, epilepsy, sever neurological disorders&#xD;
&#xD;
          -  Participation in other exercise- or nutrition studies within the last 6 months&#xD;
&#xD;
          -  acute cardiovascular disease&#xD;
&#xD;
          -  malignant disease&#xD;
&#xD;
          -  Electronic implants (defibrillator, pacemaker)&#xD;
&#xD;
          -  Persons in mental hospitals by order of authorities or jurisdiction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dejan Reljic, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Erlangen Nuremberg Medical School</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yurdaguel Zopf, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Erlangen Nuremberg Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports,</name>
      <address>
        <city>Erlangen</city>
        <zip>91052</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>October 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>September 10, 2020</last_update_submitted>
  <last_update_submitted_qc>September 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aerobic exercise</keyword>
  <keyword>Interval training</keyword>
  <keyword>VO2max</keyword>
  <keyword>Health Promotion</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Body Composition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Metabolic Syndrome</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/NCT03306069
org study id: BELITA-Study
nct id: NCT03306069
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study is to compare the impact of aerobic interval training
      intensity on exercise adherence and changes in cardiorespiratory fitness, cardiometabolic
      risk profile, body composition, inflammatory markers and subjective health outcomes after a
      12-week intervention trial in overweight individuals at increased cardiometabolic risk.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel Assignment parallel-group, randomized-controlled study
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Outcome Assessors involved in data analysis will not be aware of the arm to which the participants were allocated (single-blinded masking).
measure: Cardiorespiratory Fitness (CRF)
time frame: 12 weeks (baseline to 12 week follow-up assessment)
description: CRF will be assessed by measuring Maximum Oxygen uptake (VO2max)
measure: Metabolic Syndrome Z-Score (MetS-Z-Score)
time frame: 12 weeks (baseline to 12 week follow-up assessment)
description: MetS-Z-Score will be calculated from each individual's measures of waist circumference, mean arterial blood pressure, triglycerides, and HDL-cholesterol, based on equations specific to sex.
measure: Body Composition
time frame: 12 weeks (baseline to 12 week follow-up assessment)
description: Muscle mass, fat mass and body water will be measured by Bioelectrical Impedance Analysis (BIA)
measure: Insulin sensitivity
time frame: 12 weeks (baseline to 12 week follow-up assessment)
description: Insulin sensitivity will be estimated using homeostasis model assessment index (HOMA)
measure: Inflammation
time frame: 12 weeks (baseline to 12 week follow-up assessment)
description: Inflammation will be assessed by measuring levels of inflammatory blood markers
measure: Health-related quality of life
time frame: 12 weeks (baseline to 12 week follow-up assessment)
description: Health-related quality of life will be assessed by using the standardized and validated EQ-5D-5L Questionnaire
measure: Pain scores
time frame: 12 weeks (baseline to 12 week follow-up assessment)
description: Pain scores will be assessed by using the standardized and validated Chronic Pain Grade Questionnaire (CPGQ)
measure: Perceived stress
time frame: 12 weeks (baseline to 12 week follow-up assessment)
description: Perceived stress will be assessed by using the standardized and validated Perceived Stress Questionnaire (PSQ)
measure: Subjective work ability
time frame: 12 weeks (baseline to 12 week follow-up assessment)
description: Subjective work ability will be assessed by using the standardized and validated Work Ability Index Questionnaire (WAI)
arm group label: Control
arm group type: Experimental
description: Nutritional therapy / no exercise
arm group label: HIIT
arm group type: Experimental
description: High-intensity interval training (HIIT) at 90% heart rate maximum (HRmax) combined with Nutritional therapy
arm group label: MIIT-HR
arm group type: Experimental
description: Heart rate based moderate-intensity interval training (MIIT-HR) at 70% heart rate maximum (HRmax) combined with Nutritional therapy
arm group label: MIIT-LT
arm group type: Experimental
description: Lactate threshold based moderate-intensity interval training (MIIT-LT) at 105% of lactate threshold (corresponding ~70-75% HRmax) combined with Nutritional therapy
intervention type: Other
intervention name: Control
description: Individualized, weight-reducing nutritional therapy and counseling, during a study period of 12 weeks
arm group label: Control
intervention type: Other
intervention name: HIIT
description: Procedures: Nutritional therapy (individualized, weightreducing nutritional therapy and counseling) during a study period of 12 weeks combined with supervised ergometer-based high-intensity interval training (HIIT).
HIIT:
2 sessions per week
5x1 min at 80-95% HRmax
time-effort per week: ~30 min
arm group label: HIIT
intervention type: Other
intervention name: MIIT-HR
description: Procedures: Nutritional therapy (individualized, weightreducing nutritional therapy and counseling) during a study period of 12 weeks combined with supervised ergometer-based moderate-intensity interval training on the basis of HRmax (MIIT-HR).
MIIT-HR:
2 sessions per week
5x1 min at 65-79% HRmax
time-effort per week: ~30 min
arm group label: MIIT-HR
intervention type: Other
intervention name: MIIT-LT
description: Procedures: Nutritional therapy (individualized, weightreducing nutritional therapy and counseling) during a study period of 12 weeks combined with supervised ergometer-based moderate-intensity interval training on the basis of lactate threshold (MIIT-LT).
MIIT-LT:
2 sessions per week
session 1: 2x4 min / session 2: 5x1 min, each at 105% LT
time-effort per week: ~30 min
arm group label: MIIT-LT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dejan Reljic, Dr.
role: Principal Investigator
affiliation: University Erlangen Nuremberg Medical School
last name: Yurdaguel Zopf, Prof.
role: Principal Investigator
affiliation: University Erlangen Nuremberg Medical School
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Overweight
mesh term: Metabolic Syndrome