<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/NCT04453098</url>
  </required_header>
  <id_info>
    <org_study_id>AOI 2018 DUTHEIL</org_study_id>
    <secondary_id>2019-A01016-51</secondary_id>
    <nct_id>NCT04453098</nct_id>
  </id_info>
  <brief_title>Results at 10 Years of the RESOLVE Study (RESOLVE+10)</brief_title>
  <acronym>RESOLVE+10</acronym>
  <official_title>Results at 10 Years of the RESOLVE Study (REverse Metabolic SyndrOme by Lifestyle and Various Exercise)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital CHU Clermont-Ferrand, 58 rue Montalembert 63003 Clermont-Ferrand, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Université d'Auvergne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>LaPSCo laboratory, Physiological and Psychosocial Stress&quot; team, UMR CNRS 6024, Clermont-Ferrand, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>LaPEC laboratory (EA 4278), University of Avignon, Avignon, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</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>
      10-year effect of a lifestyle intervention program (exercise, sedentary lifestyle and dietary&#xD;
      diet) on abdominal visceral adipose tissue (primary endpoint of the RESOLVE study 10 years&#xD;
      ago): influence of kinetics abdominal visceral adipose tissue loss in the first year of&#xD;
      follow-up on abdominal visceral adipose tissue at 10 years&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The RESOLVE + 10 protocol was design to provide a 10-year effect of a lifestyle intervention&#xD;
      program (exercise, sedentary lifestyle and dietary diet) on abdominal visceral adipose&#xD;
      tissue.&#xD;
&#xD;
      In the present protocol, parameters are measured just once, during 3 hours, to compared the&#xD;
      results with those of the protocol RESOLVE (5 measurement times over a year 10 years ago:&#xD;
      before the thermal modification program of the lifestyle ( exercise, sedentary lifestyle and&#xD;
      diet) of 3 weeks (D0), after the thermal program (D21), at the 3rd month (M3), 6th month (M6)&#xD;
      and 12th month of follow-up (M12), to which was matched a healthy control group).&#xD;
&#xD;
      Statistical analysis will be performed using Stata software (version 13; Stata-Corp, College&#xD;
      Station, Tex., USA). All statistical tests will be two-sided and p inferior to 0.05 will be&#xD;
      considered significant. Qualitative variables will be described in terms of numbers and&#xD;
      proportions. Quantitative variables will be described in terms of numbers, mean standard&#xD;
      deviation or median according to statistical distribution (normality studied using&#xD;
      Shapiro-Wilk test). Graphic representations will be complete presentations of results.&#xD;
      Comparisons between patients and controls, concerning loss of abdominal visceral adipose&#xD;
      tissue at 10 years, will be performed using Student t-test or Mann-Whitney test if the&#xD;
      assumptions of anova are not met (normality and homoscedasticity analyzed using&#xD;
      Fisher-Snedecor test). The results will be expressed as effect-size and 95 percent confidence&#xD;
      intervals. The primary analysis should be completed by multivariable analysis (linear&#xD;
      regression with logarithmic transformation of dependent outcome if necessary) considering an&#xD;
      adjustment on covariates fixed according to univariate results and clinical relevance. The&#xD;
      results will be expressed as regression coefficients and 95percent confidence intervals.&#xD;
      Furthermore, the abdominal visceral adipose tissue loss kinetics in the first year of&#xD;
      follow-up will be considered an independent variable and treated as a functional variable.&#xD;
      The intra-group comparisons (for patients and for controls) will be performed using paired&#xD;
      statistical tests: paired t-test or Wilcoxon test. The results will be expressed as&#xD;
      effect-size and 95 percent confidence intervals. Comparisons between independent groups will&#xD;
      be done similarly as presented previously for other quantitative outcomes (body composition,&#xD;
      quality of life, skin conductance, etc.). Multivariable analyses will be applied similarly as&#xD;
      described previously. The comparisons concerning categorical variables will be realized using&#xD;
      Chi-squared or when appropriate Fischer-exact test. The relations between quantitative&#xD;
      outcomes will be analyzed using correlation coefficients (Pearson or Spearman according to&#xD;
      statistical distribution). Considering the several multiple comparisons, a correction of the&#xD;
      type I error will be applied (Sidak's correction).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">July 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>
    <intervention_model_description>participants receive an intervention throughout the protocol</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Abdominal visceral adipose tissue loss, a primary cardiovascular risk (CVR) factor, highly related to morbidity and mortality</measure>
    <time_frame>Year 10</time_frame>
    <description>to assess the ability of a lifestyle program in decreasing abdominal visceral fat, one of the major health-related factor It will be assessed from dual-energy X-ray absorptiometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>weight</measure>
    <time_frame>Year 10</time_frame>
    <description>measured in kilogramms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>systolic blood pressure</measure>
    <time_frame>Year 10</time_frame>
    <description>measured in millimeter of mercure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diastolic blood pressure</measure>
    <time_frame>Year 10</time_frame>
    <description>measured in millimeter of mercure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>Year 10</time_frame>
    <description>measured in centimeter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate</measure>
    <time_frame>Year 10</time_frame>
    <description>measured in battment per minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle mass</measure>
    <time_frame>Year 10</time_frame>
    <description>measured using Impedancemeter, Densitometry x-ray absorption, Peripheral quantitative computed tomography (pQCT) and Quantitative ultrasounds (QUS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fat mass</measure>
    <time_frame>Year 10</time_frame>
    <description>measured using Impedancemeter, Densitometry x-ray absorption, Peripheral quantitative computed tomography (pQCT) and Quantitative ultrasounds (QUS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bone structure</measure>
    <time_frame>Year 10</time_frame>
    <description>measured using Impedancemeter, Densitometry x-ray absorption, Peripheral quantitative computed tomography (pQCT) and Quantitative ultrasounds (QUS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epicardial adipose tissue</measure>
    <time_frame>Year 10</time_frame>
    <description>measures of epicardial adipose tissue using Magnetic resonance imaging (MRI) and echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>myocardial triglycerides</measure>
    <time_frame>Year 10</time_frame>
    <description>measures of myocardial triglycerides using MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiac remodeling and function</measure>
    <time_frame>Year 10</time_frame>
    <description>measures cardiac remodeling and function using MRI and echocardiography)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing depression using Hospital anxiety and depression scale- HAD. It's a 14-item questionnaire about frequency of perception about anxious (HAD-A: 7 items) and depressive (HAD-D: 7 items) symptoms. Items are made of a 4-point scale frequency of symptoms, varying from &quot;never&quot; to &quot;always&quot;. Scores higher than 8 for HAD-A or HAD-D mean a possible symptomatology, and scores higher than 11 mean a clear and proper diagnostic of depressive or anxious disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anxiety</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing anxiety using State and trait anxiety inventory which consists of separate self-report scales measuring to distinct anxiety concepts: state anxiety and trait anxiety. Both state and trait anxiety are explored by a 20-item questionnaire made of a 4-point scale from &quot;never&quot; to &quot;always&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General health</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing general health using General Health Questionnaire with 36 items (SF-36)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing stress using visual analog scale of 100 mm, ranging from very low (0) to very high (100).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing fatigue using visual analog scale of 100 mm, ranging from very low (0) to very high (100).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing sleep using visual analog scale of 100 mm, ranging from very low (0) to very high (100).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Burnout</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing burnout using Maslach Burnout Inventory, composed of 22 items designed to assess the three components of the burn-out syndrome: emotional exhaustion (9 items), depersonalization (5 items) and reduced personal accomplishment (8 items). Items are made of a 7-point scale frequency of feelings, varying from &quot;never&quot; to &quot;every day&quot;. The scores for each component of the burn-out syndrome are considered separately and are not combined into a single total score. If desired for participant feedback, each score can be coded as low, average, or high.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindfulness</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing mindfulness using Freiburg Mindfulness Inventory a consistent and reliable scale evaluating several important aspects of mindfulness. Mindfulness has been described as a non-elaborative, non-judgmental present-centred awareness in which each thought, feeling or sensation that arises in the attention field is acknowledged and accepted as it is. Mindfulness appears as an attribute of consciousness long believed to promote well-being. Each self-descriptive statement of the FMI is evaluated using a four-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coping strategy</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing coping using Brief COPE Questionnaire made to evaluate self-perceived reaction to a particular situation. The 28 items of the BCQ explore the 14 different theoretically identified coping responses (with two items for each of the measured coping strategies): self-distraction, active coping, denial, substance use, use of emotional support, use of instrumental support, Behavioral disengagement, venting, positive reframing, planning, humor, acceptance, religion, and self-blame. Items of BCQ are scored on a four-point Likert-type scale, ranging from 1 = strongly disagree to 4 = strongly agree.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotions</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing emotions using Emotion Regulation Questionnaire a 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: 1) cognitive reappraisal and 2) expressive suppression. Respondents answer each item on a 7-point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of work</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing perception of work using Job Content Questionnaire of Karasek which assessed job demands, job control and social support through 26 items. The questionnaire measures 9 items of job demands, 9 items of job control and 8 items of social support. Items are scored on a four-point Likert-type scale, ranging from 1 = strongly disagree to 4 = strongly agree. Among the 26 items, 5 negative statements require reverse scoring. From French data, the job strain threshold is set for a demands score higher than 20 and a control score lower than 71; the isostrain threshold is determined from a combining score of job strain and social support lower than 24. We would ask the participants to fulfil the questionnaire from memories that they keep of their work.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing self-efficacy using Perceived self-efficacy scale created to assess a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events. Responses are made on a 4-point scale for the 10 items (from &quot;false&quot; to &quot;true&quot;). The final composite score (ranged from 10 to 40) is obtained by summing up the responses to all 10 items. An example of item is &quot;I am confident that I could deal efficiently with unexpected events&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Addiction</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing addiction to work using Work Addiction Risk test (WART). The WART is a self-administered test with 25 statements for which the answers are scored 1-never true to 4-always true [20,26]. Respondents read the statements and mark their answers to describe their work habits [19,27]. The total score is the sum of the responses to the items-25 to 100-and the higher the score, the more one is considered addicted to work [18,21]. Scores from 25 to 56 were defined as &quot;at low-risk of work addiction&quot;; 57 to 66 as &quot;at medium-risk of work addiction&quot;, and from 67 to 100 as &quot;at high-risk of work addiction&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alexithymia</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing alexithymia using Toronto Alexithymia Scale For this scale, a three-factor structure was proposed: difficulty identifying feelings, difficulty describing feelings and externally oriented thinking. Responses are made on a 5-point scale from &quot;strongly agree&quot; to &quot;strongly disagree&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Illness perception</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing illness perception using Brief Illness Perception Questionnaire (B-IPQ), adapted for stress at work). It's a self-questionnaire comprising an 11-point scale, including 8 items measuring cognitive and emotional illness perceptions (consequences, timeline, personal control, treatment control, symptoms, coherence, illness concern and negative emotions). The total score is calculated by averaging all items (after reversed some items). A high score meant that diabetes was perceived as a threat.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metacognition</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing metacognition using MetaCognition Questionnaire. It is a 30-item questionnaire made of 5-point scales. The MCQ-30 is structured in five factors: cognitive confidence, positive beliefs about worry, cognitive self-consciousness, negative beliefs about uncontrollability of thoughts and danger, and beliefs about need to control thoughts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time perception</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing time perception using Zimbardo Time Perspective Inventory, a self-reported questionnaire comprising 56 items. Responses are made on a 5-point scale from &quot;very uncharacteristic&quot; to &quot;very characteristic&quot;. It explores 3 temporalities and 5 dimensions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Life style</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing factors regarding lifestyle are related to smoking, alcohol, coffee, food intake (questionnaires), and physical activity (Recent Physical Activity Questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment perception</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing factors regarding psychology and treatment are related to perception of treatment (Beliefs about Medicines Questionnaire), adherence to treatment (Visual analog scales from never to always), barriers to treatment (QUILAM) and treatment satisfaction (treatment SATisfaction with MEDicines Questionnaire).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>questionnaires used 10 years ago</measure>
    <time_frame>Year 10</time_frame>
    <description>Understanding and knowledge about the metabolic syndrome (4 items), comparative optimism (4 items), motivation to eat healthy (16 items) and motivation to practise physical activity (16 items).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cholesterol</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on HDLc and LDL-cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides (TG)</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on Triglycerides (TG)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cortisol</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on Cortisol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DHEAS</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on DHEAS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leptin</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on Leptin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BDnF</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on BDnF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokines</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on Pro-inflammatory Cytokines: IL-1β, IL-6, IL-1, TNFα, NPY</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Telomeres length</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on Telomeres length</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genetic polymorphisms related to stress</measure>
    <time_frame>Year 10</time_frame>
    <description>Polymorphism of the angiotensin converting enzyme and Polymorphism of the serotonin are measured by Blood cells</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>carotid intima-media thickness</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing on carotid intima-media thickness by high-resolution B-mode ultrasound.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood flow velocity</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing on blood flow velocity by laser speckle contrast imaging (LSCI) and microvascular perfusion by laser-doppler flowmetry (LDF), flowmotion and Iontophoresis procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>microvascular perfusion</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing microvascular perfusion by laser-doppler flowmetry (LDF).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>flowmotion</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing flowmotion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>iontophoresis</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing iontophoresis procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate variability</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing heart rate variability by Holter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>skin conductance</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing skin conductance by Wristband electrodes - Empatica 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantification of liver steatosis and fibrosis</measure>
    <time_frame>Year 10</time_frame>
    <description>Liver steatosis by MRI, fibroscanner (ultrasonic attenuation) and Aixplorer (Lipersonic Imagine®).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantification of liver fibrosis</measure>
    <time_frame>Year 10</time_frame>
    <description>Liver fibrosis by fibroscanner (liver stiffness) and fibrotest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vo2max</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing factors regarding fitness are related to Vo2max (maximal exercise test)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fitness</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing factors regarding fitness are related to 6-minutes walking test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>strength</measure>
    <time_frame>Year 10</time_frame>
    <description>Assessing factors regarding fitness are related to strength</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>leptin variation</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on leptin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ghrelin variation</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on ghrelin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NPY variation</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on NPY</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adiponectin variation</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on adiponectin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of CCK level</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on CCK</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of VEGF level</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on VEGF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of PAI1 level</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on PAI1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>insulin level</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on insulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c level</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood glucose level</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on blood glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>albumin level</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on blood albumin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>transthyretin level</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on transthyretin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Homeostasis</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on Homeostasis (Fibroblast growth factor 23)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Osteoresorption</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on Osteoresorption (C-terminal Telopeptide of Type I collagen)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Osteoformation</measure>
    <time_frame>Year 10</time_frame>
    <description>Blood analyses on Osteoformation (decarboxylated osteocalcine and BSAP)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Re group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>high-Resistance-moderate-endurance, participants performed 10 repetitions at 70% of one maximal repetition in resistance and 30% of VO2-peak for endurance training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>rE group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>moderate-resistance (30%) - high-Endurance (70%)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>re group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>moderate-resistance (30%) - moderate-endurance (30%).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>3-week residential program based on a tryptic (diet,</intervention_name>
    <description>3-week residential program based on a tryptic (diet, exercise, education). The three weeks intervention was followed by a 1-year at-home follow-up.&#xD;
In the original protocol, participants were involved in a 3-week residential program based on a tryptic (diet, exercise, education).</description>
    <arm_group_label>Re group</arm_group_label>
    <arm_group_label>rE group</arm_group_label>
    <arm_group_label>re group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients and healthy controls included in the RESOLVE study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal of participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frédéric Dutheil</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lise LACLAUTRE</last_name>
    <phone>+33473754963</phone>
    <email>promo_interne_drci@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Lise Laclautre</last_name>
      <phone>+33473754963</phone>
      <email>promo_interne_drci@chu-clermontferrand.fr</email>
    </contact>
    <investigator>
      <last_name>Frédéric Dutheil</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>physical activity</keyword>
  <keyword>spa residential lifestyle program</keyword>
  <keyword>prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>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/NCT04453098
org study id: AOI 2018 DUTHEIL
secondary id: 2019-A01016-51
nct id: NCT04453098
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
10-year effect of a lifestyle intervention program (exercise, sedentary lifestyle and dietary
      diet) on abdominal visceral adipose tissue (primary endpoint of the RESOLVE study 10 years
      ago): influence of kinetics abdominal visceral adipose tissue loss in the first year of
      follow-up on abdominal visceral adipose tissue at 10 years
The RESOLVE + 10 protocol was design to provide a 10-year effect of a lifestyle intervention
      program (exercise, sedentary lifestyle and dietary diet) on abdominal visceral adipose
      tissue.

      In the present protocol, parameters are measured just once, during 3 hours, to compared the
      results with those of the protocol RESOLVE (5 measurement times over a year 10 years ago:
      before the thermal modification program of the lifestyle ( exercise, sedentary lifestyle and
      diet) of 3 weeks (D0), after the thermal program (D21), at the 3rd month (M3), 6th month (M6)
      and 12th month of follow-up (M12), to which was matched a healthy control group).

      Statistical analysis will be performed using Stata software (version 13; Stata-Corp, College
      Station, Tex., USA). All statistical tests will be two-sided and p inferior to 0.05 will be
      considered significant. Qualitative variables will be described in terms of numbers and
      proportions. Quantitative variables will be described in terms of numbers, mean standard
      deviation or median according to statistical distribution (normality studied using
      Shapiro-Wilk test). Graphic representations will be complete presentations of results.
      Comparisons between patients and controls, concerning loss of abdominal visceral adipose
      tissue at 10 years, will be performed using Student t-test or Mann-Whitney test if the
      assumptions of anova are not met (normality and homoscedasticity analyzed using
      Fisher-Snedecor test). The results will be expressed as effect-size and 95 percent confidence
      intervals. The primary analysis should be completed by multivariable analysis (linear
      regression with logarithmic transformation of dependent outcome if necessary) considering an
      adjustment on covariates fixed according to univariate results and clinical relevance. The
      results will be expressed as regression coefficients and 95percent confidence intervals.
      Furthermore, the abdominal visceral adipose tissue loss kinetics in the first year of
      follow-up will be considered an independent variable and treated as a functional variable.
      The intra-group comparisons (for patients and for controls) will be performed using paired
      statistical tests: paired t-test or Wilcoxon test. The results will be expressed as
      effect-size and 95 percent confidence intervals. Comparisons between independent groups will
      be done similarly as presented previously for other quantitative outcomes (body composition,
      quality of life, skin conductance, etc.). Multivariable analyses will be applied similarly as
      described previously. The comparisons concerning categorical variables will be realized using
      Chi-squared or when appropriate Fischer-exact test. The relations between quantitative
      outcomes will be analyzed using correlation coefficients (Pearson or Spearman according to
      statistical distribution). Considering the several multiple comparisons, a correction of the
      type I error will be applied (Sidak's correction).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: participants receive an intervention throughout the protocol
primary purpose: Prevention
masking: None (Open Label)
measure: Abdominal visceral adipose tissue loss, a primary cardiovascular risk (CVR) factor, highly related to morbidity and mortality
time frame: Year 10
description: to assess the ability of a lifestyle program in decreasing abdominal visceral fat, one of the major health-related factor It will be assessed from dual-energy X-ray absorptiometry
measure: weight
time frame: Year 10
description: measured in kilogramms
measure: systolic blood pressure
time frame: Year 10
description: measured in millimeter of mercure
measure: diastolic blood pressure
time frame: Year 10
description: measured in millimeter of mercure
measure: Waist circumference
time frame: Year 10
description: measured in centimeter
measure: heart rate
time frame: Year 10
description: measured in battment per minutes
measure: Muscle mass
time frame: Year 10
description: measured using Impedancemeter, Densitometry x-ray absorption, Peripheral quantitative computed tomography (pQCT) and Quantitative ultrasounds (QUS)
measure: fat mass
time frame: Year 10
description: measured using Impedancemeter, Densitometry x-ray absorption, Peripheral quantitative computed tomography (pQCT) and Quantitative ultrasounds (QUS)
measure: bone structure
time frame: Year 10
description: measured using Impedancemeter, Densitometry x-ray absorption, Peripheral quantitative computed tomography (pQCT) and Quantitative ultrasounds (QUS)
measure: Epicardial adipose tissue
time frame: Year 10
description: measures of epicardial adipose tissue using Magnetic resonance imaging (MRI) and echocardiography
measure: myocardial triglycerides
time frame: Year 10
description: measures of myocardial triglycerides using MRI
measure: cardiac remodeling and function
time frame: Year 10
description: measures cardiac remodeling and function using MRI and echocardiography)
measure: Depression
time frame: Year 10
description: Assessing depression using Hospital anxiety and depression scale- HAD. It's a 14-item questionnaire about frequency of perception about anxious (HAD-A: 7 items) and depressive (HAD-D: 7 items) symptoms. Items are made of a 4-point scale frequency of symptoms, varying from "never" to "always". Scores higher than 8 for HAD-A or HAD-D mean a possible symptomatology, and scores higher than 11 mean a clear and proper diagnostic of depressive or anxious disorder.
measure: anxiety
time frame: Year 10
description: Assessing anxiety using State and trait anxiety inventory which consists of separate self-report scales measuring to distinct anxiety concepts: state anxiety and trait anxiety. Both state and trait anxiety are explored by a 20-item questionnaire made of a 4-point scale from "never" to "always".
measure: General health
time frame: Year 10
description: Assessing general health using General Health Questionnaire with 36 items (SF-36)
measure: Stress
time frame: Year 10
description: Assessing stress using visual analog scale of 100 mm, ranging from very low (0) to very high (100).
measure: Fatigue
time frame: Year 10
description: Assessing fatigue using visual analog scale of 100 mm, ranging from very low (0) to very high (100).
measure: Sleep
time frame: Year 10
description: Assessing sleep using visual analog scale of 100 mm, ranging from very low (0) to very high (100).
measure: Burnout
time frame: Year 10
description: Assessing burnout using Maslach Burnout Inventory, composed of 22 items designed to assess the three components of the burn-out syndrome: emotional exhaustion (9 items), depersonalization (5 items) and reduced personal accomplishment (8 items). Items are made of a 7-point scale frequency of feelings, varying from "never" to "every day". The scores for each component of the burn-out syndrome are considered separately and are not combined into a single total score. If desired for participant feedback, each score can be coded as low, average, or high.
measure: Mindfulness
time frame: Year 10
description: Assessing mindfulness using Freiburg Mindfulness Inventory a consistent and reliable scale evaluating several important aspects of mindfulness. Mindfulness has been described as a non-elaborative, non-judgmental present-centred awareness in which each thought, feeling or sensation that arises in the attention field is acknowledged and accepted as it is. Mindfulness appears as an attribute of consciousness long believed to promote well-being. Each self-descriptive statement of the FMI is evaluated using a four-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree)
measure: Coping strategy
time frame: Year 10
description: Assessing coping using Brief COPE Questionnaire made to evaluate self-perceived reaction to a particular situation. The 28 items of the BCQ explore the 14 different theoretically identified coping responses (with two items for each of the measured coping strategies): self-distraction, active coping, denial, substance use, use of emotional support, use of instrumental support, Behavioral disengagement, venting, positive reframing, planning, humor, acceptance, religion, and self-blame. Items of BCQ are scored on a four-point Likert-type scale, ranging from 1 = strongly disagree to 4 = strongly agree.
measure: Emotions
time frame: Year 10
description: Assessing emotions using Emotion Regulation Questionnaire a 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: 1) cognitive reappraisal and 2) expressive suppression. Respondents answer each item on a 7-point
measure: Perception of work
time frame: Year 10
description: Assessing perception of work using Job Content Questionnaire of Karasek which assessed job demands, job control and social support through 26 items. The questionnaire measures 9 items of job demands, 9 items of job control and 8 items of social support. Items are scored on a four-point Likert-type scale, ranging from 1 = strongly disagree to 4 = strongly agree. Among the 26 items, 5 negative statements require reverse scoring. From French data, the job strain threshold is set for a demands score higher than 20 and a control score lower than 71; the isostrain threshold is determined from a combining score of job strain and social support lower than 24. We would ask the participants to fulfil the questionnaire from memories that they keep of their work.
measure: Self-efficacy
time frame: Year 10
description: Assessing self-efficacy using Perceived self-efficacy scale created to assess a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events. Responses are made on a 4-point scale for the 10 items (from "false" to "true"). The final composite score (ranged from 10 to 40) is obtained by summing up the responses to all 10 items. An example of item is "I am confident that I could deal efficiently with unexpected events".
measure: Addiction
time frame: Year 10
description: Assessing addiction to work using Work Addiction Risk test (WART). The WART is a self-administered test with 25 statements for which the answers are scored 1-never true to 4-always true [20,26]. Respondents read the statements and mark their answers to describe their work habits [19,27]. The total score is the sum of the responses to the items-25 to 100-and the higher the score, the more one is considered addicted to work [18,21]. Scores from 25 to 56 were defined as "at low-risk of work addiction"; 57 to 66 as "at medium-risk of work addiction", and from 67 to 100 as "at high-risk of work addiction".
measure: Alexithymia
time frame: Year 10
description: Assessing alexithymia using Toronto Alexithymia Scale For this scale, a three-factor structure was proposed: difficulty identifying feelings, difficulty describing feelings and externally oriented thinking. Responses are made on a 5-point scale from "strongly agree" to "strongly disagree".
measure: Illness perception
time frame: Year 10
description: Assessing illness perception using Brief Illness Perception Questionnaire (B-IPQ), adapted for stress at work). It's a self-questionnaire comprising an 11-point scale, including 8 items measuring cognitive and emotional illness perceptions (consequences, timeline, personal control, treatment control, symptoms, coherence, illness concern and negative emotions). The total score is calculated by averaging all items (after reversed some items). A high score meant that diabetes was perceived as a threat.
measure: Metacognition
time frame: Year 10
description: Assessing metacognition using MetaCognition Questionnaire. It is a 30-item questionnaire made of 5-point scales. The MCQ-30 is structured in five factors: cognitive confidence, positive beliefs about worry, cognitive self-consciousness, negative beliefs about uncontrollability of thoughts and danger, and beliefs about need to control thoughts.
measure: Time perception
time frame: Year 10
description: Assessing time perception using Zimbardo Time Perspective Inventory, a self-reported questionnaire comprising 56 items. Responses are made on a 5-point scale from "very uncharacteristic" to "very characteristic". It explores 3 temporalities and 5 dimensions.
measure: Life style
time frame: Year 10
description: Assessing factors regarding lifestyle are related to smoking, alcohol, coffee, food intake (questionnaires), and physical activity (Recent Physical Activity Questionnaire)
measure: Treatment perception
time frame: Year 10
description: Assessing factors regarding psychology and treatment are related to perception of treatment (Beliefs about Medicines Questionnaire), adherence to treatment (Visual analog scales from never to always), barriers to treatment (QUILAM) and treatment satisfaction (treatment SATisfaction with MEDicines Questionnaire).
measure: questionnaires used 10 years ago
time frame: Year 10
description: Understanding and knowledge about the metabolic syndrome (4 items), comparative optimism (4 items), motivation to eat healthy (16 items) and motivation to practise physical activity (16 items).
measure: Cholesterol
time frame: Year 10
description: Blood analyses on HDLc and LDL-cholesterol
measure: HbA1c
time frame: Year 10
description: Blood analyses on HbA1c
measure: Triglycerides (TG)
time frame: Year 10
description: Blood analyses on Triglycerides (TG)
measure: Cortisol
time frame: Year 10
description: Blood analyses on Cortisol
measure: DHEAS
time frame: Year 10
description: Blood analyses on DHEAS
measure: Leptin
time frame: Year 10
description: Blood analyses on Leptin
measure: BDnF
time frame: Year 10
description: Blood analyses on BDnF
measure: Cytokines
time frame: Year 10
description: Blood analyses on Pro-inflammatory Cytokines: IL-1β, IL-6, IL-1, TNFα, NPY
measure: Telomeres length
time frame: Year 10
description: Blood analyses on Telomeres length
measure: Genetic polymorphisms related to stress
time frame: Year 10
description: Polymorphism of the angiotensin converting enzyme and Polymorphism of the serotonin are measured by Blood cells
measure: carotid intima-media thickness
time frame: Year 10
description: Assessing on carotid intima-media thickness by high-resolution B-mode ultrasound.
measure: blood flow velocity
time frame: Year 10
description: Assessing on blood flow velocity by laser speckle contrast imaging (LSCI) and microvascular perfusion by laser-doppler flowmetry (LDF), flowmotion and Iontophoresis procedure.
measure: microvascular perfusion
time frame: Year 10
description: Assessing microvascular perfusion by laser-doppler flowmetry (LDF).
measure: flowmotion
time frame: Year 10
description: Assessing flowmotion
measure: iontophoresis
time frame: Year 10
description: Assessing iontophoresis procedure
measure: heart rate variability
time frame: Year 10
description: Assessing heart rate variability by Holter
measure: skin conductance
time frame: Year 10
description: Assessing skin conductance by Wristband electrodes - Empatica 4.
measure: Quantification of liver steatosis and fibrosis
time frame: Year 10
description: Liver steatosis by MRI, fibroscanner (ultrasonic attenuation) and Aixplorer (Lipersonic Imagine®).
measure: Quantification of liver fibrosis
time frame: Year 10
description: Liver fibrosis by fibroscanner (liver stiffness) and fibrotest
measure: Vo2max
time frame: Year 10
description: Assessing factors regarding fitness are related to Vo2max (maximal exercise test)
measure: Fitness
time frame: Year 10
description: Assessing factors regarding fitness are related to 6-minutes walking test.
measure: strength
time frame: Year 10
description: Assessing factors regarding fitness are related to strength
measure: leptin variation
time frame: Year 10
description: Blood analyses on leptin
measure: ghrelin variation
time frame: Year 10
description: Blood analyses on ghrelin
measure: NPY variation
time frame: Year 10
description: Blood analyses on NPY
measure: adiponectin variation
time frame: Year 10
description: Blood analyses on adiponectin
measure: Evaluation of CCK level
time frame: Year 10
description: Blood analyses on CCK
measure: Evaluation of VEGF level
time frame: Year 10
description: Blood analyses on VEGF
measure: Evaluation of PAI1 level
time frame: Year 10
description: Blood analyses on PAI1
measure: insulin level
time frame: Year 10
description: Blood analyses on insulin
measure: HbA1c level
time frame: Year 10
description: Blood analyses on HbA1c
measure: blood glucose level
time frame: Year 10
description: Blood analyses on blood glucose
measure: albumin level
time frame: Year 10
description: Blood analyses on blood albumin
measure: transthyretin level
time frame: Year 10
description: Blood analyses on transthyretin
measure: Homeostasis
time frame: Year 10
description: Blood analyses on Homeostasis (Fibroblast growth factor 23)
measure: Osteoresorption
time frame: Year 10
description: Blood analyses on Osteoresorption (C-terminal Telopeptide of Type I collagen)
measure: Osteoformation
time frame: Year 10
description: Blood analyses on Osteoformation (decarboxylated osteocalcine and BSAP)
arm group label: Re group
arm group type: Experimental
description: high-Resistance-moderate-endurance, participants performed 10 repetitions at 70% of one maximal repetition in resistance and 30% of VO2-peak for endurance training
arm group label: rE group
arm group type: Experimental
description: moderate-resistance (30%) - high-Endurance (70%)
arm group label: re group
arm group type: Experimental
description: moderate-resistance (30%) - moderate-endurance (30%).
arm group label: control group
arm group type: No Intervention
description: no intervention
intervention type: Behavioral
intervention name: 3-week residential program based on a tryptic (diet,
description: 3-week residential program based on a tryptic (diet, exercise, education). The three weeks intervention was followed by a 1-year at-home follow-up.
In the original protocol, participants were involved in a 3-week residential program based on a tryptic (diet, exercise, education).
arm group label: Re group
arm group label: rE group
arm group label: re group
criteria: 
gender: All
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Frédéric Dutheil
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
last name: Lise LACLAUTRE
phone: +33473754963
email: promo_interne_drci@chu-clermontferrand.fr
facility: 
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Metabolic Syndrome
mesh term: Syndrome