An interventional study of 3-week residential program based on a tryptic (diet, in Metabolic Syndrome, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-01.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Prevention
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).
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's planned enrollment of 150 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
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Exclusion Criteria:
high-Resistance-moderate-endurance, participants performed 10 repetitions at 70% of one maximal repetition in resistance and 30% of VO2-peak for endurance training
Behavioral: 3-week residential program based on a tryptic (diet,
moderate-resistance (30%) - high-Endurance (70%)
Behavioral: 3-week residential program based on a tryptic (diet,
moderate-resistance (30%) - moderate-endurance (30%).
Behavioral: 3-week residential program based on a tryptic (diet,
no intervention
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).
Abdominal visceral adipose tissue loss, a primary cardiovascular risk (CVR) factor, highly related to morbidity and mortality
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
Time frame: Year 10
weight
measured in kilogramms
Time frame: Year 10
systolic blood pressure
measured in millimeter of mercure
Time frame: Year 10
diastolic blood pressure
measured in millimeter of mercure
Time frame: Year 10
Waist circumference
measured in centimeter
Time frame: Year 10
heart rate
measured in battment per minutes
Time frame: Year 10
Muscle mass
measured using Impedancemeter, Densitometry x-ray absorption, Peripheral quantitative computed tomography (pQCT) and Quantitative ultrasounds (QUS)
Time frame: Year 10
fat mass
measured using Impedancemeter, Densitometry x-ray absorption, Peripheral quantitative computed tomography (pQCT) and Quantitative ultrasounds (QUS)
Time frame: Year 10
bone structure
measured using Impedancemeter, Densitometry x-ray absorption, Peripheral quantitative computed tomography (pQCT) and Quantitative ultrasounds (QUS)
Time frame: Year 10
Epicardial adipose tissue
measures of epicardial adipose tissue using Magnetic resonance imaging (MRI) and echocardiography
Time frame: Year 10
myocardial triglycerides
measures of myocardial triglycerides using MRI
Time frame: Year 10
cardiac remodeling and function
measures cardiac remodeling and function using MRI and echocardiography)
Time frame: Year 10
Depression
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.
Time frame: Year 10
anxiety
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".
Time frame: Year 10
General health
Assessing general health using General Health Questionnaire with 36 items (SF-36)
Time frame: Year 10
Stress
Assessing stress using visual analog scale of 100 mm, ranging from very low (0) to very high (100).
Time frame: Year 10
Fatigue
Assessing fatigue using visual analog scale of 100 mm, ranging from very low (0) to very high (100).
Time frame: Year 10
Sleep
Assessing sleep using visual analog scale of 100 mm, ranging from very low (0) to very high (100).
Time frame: Year 10
Burnout
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.
Time frame: Year 10
Mindfulness
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)
Time frame: Year 10
Coping strategy
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.
Time frame: Year 10
Emotions
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
Time frame: Year 10
Perception of work
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.
Time frame: Year 10
Self-efficacy
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".
Time frame: Year 10
Addiction
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".
Time frame: Year 10
Alexithymia
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".
Time frame: Year 10
Illness perception
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.
Time frame: Year 10
Metacognition
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.
Time frame: Year 10
Time perception
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.
Time frame: Year 10
Life style
Assessing factors regarding lifestyle are related to smoking, alcohol, coffee, food intake (questionnaires), and physical activity (Recent Physical Activity Questionnaire)
Time frame: Year 10
Treatment perception
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).
Time frame: Year 10
questionnaires used 10 years ago
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).
Time frame: Year 10
Cholesterol
Blood analyses on HDLc and LDL-cholesterol
Time frame: Year 10
HbA1c
Blood analyses on HbA1c
Time frame: Year 10
Triglycerides (TG)
Blood analyses on Triglycerides (TG)
Time frame: Year 10
Cortisol
Blood analyses on Cortisol
Time frame: Year 10
DHEAS
Blood analyses on DHEAS
Time frame: Year 10
Leptin
Blood analyses on Leptin
Time frame: Year 10
BDnF
Blood analyses on BDnF
Time frame: Year 10
Cytokines
Blood analyses on Pro-inflammatory Cytokines: IL-1β, IL-6, IL-1, TNFα, NPY
Time frame: Year 10
Telomeres length
Blood analyses on Telomeres length
Time frame: Year 10
Genetic polymorphisms related to stress
Polymorphism of the angiotensin converting enzyme and Polymorphism of the serotonin are measured by Blood cells
Time frame: Year 10
carotid intima-media thickness
Assessing on carotid intima-media thickness by high-resolution B-mode ultrasound.
Time frame: Year 10
blood flow velocity
Assessing on blood flow velocity by laser speckle contrast imaging (LSCI) and microvascular perfusion by laser-doppler flowmetry (LDF), flowmotion and Iontophoresis procedure.
Time frame: Year 10
microvascular perfusion
Assessing microvascular perfusion by laser-doppler flowmetry (LDF).
Time frame: Year 10
flowmotion
Assessing flowmotion
Time frame: Year 10
iontophoresis
Assessing iontophoresis procedure
Time frame: Year 10
heart rate variability
Assessing heart rate variability by Holter
Time frame: Year 10
skin conductance
Assessing skin conductance by Wristband electrodes - Empatica 4.
Time frame: Year 10
Quantification of liver steatosis and fibrosis
Liver steatosis by MRI, fibroscanner (ultrasonic attenuation) and Aixplorer (Lipersonic Imagine®).
Time frame: Year 10
Quantification of liver fibrosis
Liver fibrosis by fibroscanner (liver stiffness) and fibrotest
Time frame: Year 10
Vo2max
Assessing factors regarding fitness are related to Vo2max (maximal exercise test)
Time frame: Year 10
Fitness
Assessing factors regarding fitness are related to 6-minutes walking test.
Time frame: Year 10
strength
Assessing factors regarding fitness are related to strength
Time frame: Year 10
leptin variation
Blood analyses on leptin
Time frame: Year 10
ghrelin variation
Blood analyses on ghrelin
Time frame: Year 10
NPY variation
Blood analyses on NPY
Time frame: Year 10
adiponectin variation
Blood analyses on adiponectin
Time frame: Year 10
Evaluation of CCK level
Blood analyses on CCK
Time frame: Year 10
Evaluation of VEGF level
Blood analyses on VEGF
Time frame: Year 10
Evaluation of PAI1 level
Blood analyses on PAI1
Time frame: Year 10
insulin level
Blood analyses on insulin
Time frame: Year 10
HbA1c level
Blood analyses on HbA1c
Time frame: Year 10
blood glucose level
Blood analyses on blood glucose
Time frame: Year 10
albumin level
Blood analyses on blood albumin
Time frame: Year 10
transthyretin level
Blood analyses on transthyretin
Time frame: Year 10
Homeostasis
Blood analyses on Homeostasis (Fibroblast growth factor 23)
Time frame: Year 10
Osteoresorption
Blood analyses on Osteoresorption (C-terminal Telopeptide of Type I collagen)
Time frame: Year 10
Osteoformation
Blood analyses on Osteoformation (decarboxylated osteocalcine and BSAP)
Time frame: Year 10
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University Hospital, Clermont-Ferrand