NCT04453098

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 1, 2020

Status Verified

June 1, 2020

Enrollment Period

10 months

First QC Date

June 22, 2020

Last Update Submit

June 29, 2020

Conditions

Metabolic Syndrome

Keywords

physical activityspa residential lifestyle programprevention

Outcome Measures

Primary Outcomes (1)

  • 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

    Year 10

Secondary Outcomes (68)

  • weight

    Year 10

  • systolic blood pressure

    Year 10

  • diastolic blood pressure

    Year 10

  • Waist circumference

    Year 10

  • heart rate

    Year 10

  • +63 more secondary outcomes

Study Arms (4)

Re group

EXPERIMENTAL

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,

rE group

EXPERIMENTAL

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

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

re group

EXPERIMENTAL

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

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

control group

NO INTERVENTION

no intervention

Interventions

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

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients and healthy controls included in the RESOLVE study

You may not qualify if:

  • refusal of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Metabolic SyndromeMotor Activity

Interventions

Diet

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Frédéric Dutheil

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+33473754963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: participants receive an intervention throughout the protocol
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2020

First Posted

July 1, 2020

Study Start

September 1, 2020

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

July 1, 2020

Record last verified: 2020-06

Locations

FR(1)