Clinical trial NCT04453098: Results at 10 Years of the RESOLVE Study (RESOLVE+10)
Official title: Results at 10 Years of the RESOLVE Study (REverse Metabolic SyndrOme by Lifestyle and Various Exercise)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Keywords: physical activity
spa residential lifestyle program
prevention
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: University Hospital CHU Clermont-Ferrand, 58 rue Montalembert 63003 Clermont-Ferrand, France
name: Université d'Auvergne
name: LaPSCo laboratory, Physiological and Psychosocial Stress" team, UMR CNRS 6024, Clermont-Ferrand, France
name: LaPEC laboratory (EA 4278), University of Avignon, Avignon, France
First posted: 2020-07-01
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants receive an intervention throughout the protocol
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* patients and healthy controls included in the RESOLVE study

Exclusion Criteria:

* refusal of participation

Primary outcomes:
measure: Abdominal visceral adipose tissue loss, a primary cardiovascular risk (CVR) factor, highly related to morbidity and mortality
timeFrame: Year 10
Secondary outcomes:
measure: weight
timeFrame: Year 10
measure: systolic blood pressure
timeFrame: Year 10
measure: diastolic blood pressure
timeFrame: Year 10
measure: Waist circumference
timeFrame: Year 10
measure: heart rate
timeFrame: Year 10
measure: Muscle mass
timeFrame: Year 10
measure: fat mass
timeFrame: Year 10
measure: bone structure
timeFrame: Year 10
measure: Epicardial adipose tissue
timeFrame: Year 10
measure: myocardial triglycerides
timeFrame: Year 10
measure: cardiac remodeling and function
timeFrame: Year 10
measure: Depression
timeFrame: Year 10
measure: anxiety
timeFrame: Year 10
measure: General health
timeFrame: Year 10
measure: Stress
timeFrame: Year 10
measure: Fatigue
timeFrame: Year 10
measure: Sleep
timeFrame: Year 10
measure: Burnout
timeFrame: Year 10
measure: Mindfulness
timeFrame: Year 10
measure: Coping strategy
timeFrame: Year 10
measure: Emotions
timeFrame: Year 10
measure: Perception of work
timeFrame: Year 10
measure: Self-efficacy
timeFrame: Year 10
measure: Addiction
timeFrame: Year 10
measure: Alexithymia
timeFrame: Year 10
measure: Illness perception
timeFrame: Year 10
measure: Metacognition
timeFrame: Year 10
measure: Time perception
timeFrame: Year 10
measure: Life style
timeFrame: Year 10
measure: Treatment perception
timeFrame: Year 10
measure: questionnaires used 10 years ago
timeFrame: Year 10
measure: Cholesterol
timeFrame: Year 10
measure: HbA1c
timeFrame: Year 10
measure: Triglycerides (TG)
timeFrame: Year 10
measure: Cortisol
timeFrame: Year 10
measure: DHEAS
timeFrame: Year 10
measure: Leptin
timeFrame: Year 10
measure: BDnF
timeFrame: Year 10
measure: Cytokines
timeFrame: Year 10
measure: Telomeres length
timeFrame: Year 10
measure: Genetic polymorphisms related to stress
timeFrame: Year 10
measure: carotid intima-media thickness
timeFrame: Year 10
measure: blood flow velocity
timeFrame: Year 10
measure: microvascular perfusion
timeFrame: Year 10
measure: flowmotion
timeFrame: Year 10
measure: iontophoresis
timeFrame: Year 10
measure: heart rate variability
timeFrame: Year 10
measure: skin conductance
timeFrame: Year 10
measure: Quantification of liver steatosis and fibrosis
timeFrame: Year 10
measure: Quantification of liver fibrosis
timeFrame: Year 10
measure: Vo2max
timeFrame: Year 10
measure: Fitness
timeFrame: Year 10
measure: strength
timeFrame: Year 10
measure: leptin variation
timeFrame: Year 10
measure: ghrelin variation
timeFrame: Year 10
measure: NPY variation
timeFrame: Year 10
measure: adiponectin variation
timeFrame: Year 10
measure: Evaluation of CCK level
timeFrame: Year 10
measure: Evaluation of VEGF level
timeFrame: Year 10
measure: Evaluation of PAI1 level
timeFrame: Year 10
measure: insulin level
timeFrame: Year 10
measure: HbA1c level
timeFrame: Year 10
measure: blood glucose level
timeFrame: Year 10
measure: albumin level
timeFrame: Year 10
measure: transthyretin level
timeFrame: Year 10
measure: Homeostasis
timeFrame: Year 10
measure: Osteoresorption
timeFrame: Year 10
measure: Osteoformation
timeFrame: Year 10
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Frédéric Dutheil
role: PRINCIPAL_INVESTIGATOR
References: