Results at 10 Years of the RESOLVE Study (RESOLVE+10)

NCT ID: NCT04453098

Last Updated: 2020-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2021-07-31

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).

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Re group

high-Resistance-moderate-endurance, participants performed 10 repetitions at 70% of one maximal repetition in resistance and 30% of VO2-peak for endurance training

Group Type: EXPERIMENTAL

3-week residential program based on a tryptic (diet,

Intervention Type: BEHAVIORAL

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).

rE group

moderate-resistance (30%) - high-Endurance (70%)

Group Type: EXPERIMENTAL

3-week residential program based on a tryptic (diet,

Intervention Type: BEHAVIORAL

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).

re group

moderate-resistance (30%) - moderate-endurance (30%).

Group Type: EXPERIMENTAL

3-week residential program based on a tryptic (diet,

Intervention Type: BEHAVIORAL

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).

control group

no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

3-week residential program based on a tryptic (diet,

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• patients and healthy controls included in the RESOLVE study

Exclusion Criteria

• refusal of participation

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital CHU Clermont-Ferrand, 58 rue Montalembert 63003 Clermont-Ferrand, France

UNKNOWN

Sponsor Role: collaborator

Université d'Auvergne

OTHER

Sponsor Role: collaborator

LaPSCo laboratory, Physiological and Psychosocial Stress" team, UMR CNRS 6024, Clermont-Ferrand, France

UNKNOWN

Sponsor Role: collaborator

LaPEC laboratory (EA 4278), University of Avignon, Avignon, France

UNKNOWN

Sponsor Role: collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédéric Dutheil

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Central Contacts

Lise LACLAUTRE

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Facility Contacts

Lise Laclautre

Role: primary

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Other Identifiers

2019-A01016-51

Identifier Type: OTHER

Identifier Source: secondary_id

AOI 2018 DUTHEIL

Identifier Type: -

Identifier Source: org_study_id