Viewing Study NCT02832453



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Last Modification Date: 2024-10-26 @ 12:05 PM
Study NCT ID: NCT02832453
Status: COMPLETED
Last Update Posted: 2019-08-21
First Post: 2016-07-06

Brief Title: Metabolic Risk Management Physical Exercise and Lifestyle Counselling in Low-active Adults Controlled Randomized Trial
Sponsor: INEFC-Lleida
Organization: INEFC-Lleida

Study Overview

Official Title: Supervised Physical Exercise and Lifestyle Counselling in the Management of Metabolic Risk in Low-active Adults a Controlled Randomized Trial Bellugat de CAP a Peus
Status: COMPLETED
Status Verified Date: 2019-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: BELLUGAT
Brief Summary: The purpose of this study is evaluate the effectiveness of different doses of supervised exercise training intensity -concomitant to lifestyle counselling- as a Primary Health Care intervention tool for the management of the metabolic syndrome in low active adults with one or more metabolic risk factors

Secondary aims of the study are to investigate the effects of these interventions on systemic inflammation and adipose tissue function cardiorespiratory fitness physical activity and sedentary habits and the cost-effectiveness of the intervention with regard to health related quality of life

The general hypothesis is that adults with risk factors for metabolic syndrome participating in interventions for the promotion of a healthy lifestyle that together with counselling strategies will include supervised physical exercise of vigorous intensity will present greater improvements in terms of metabolic risk physical condition physical activitysedentary behaviours and psychological parameters at the end of the intervention and at 6-months follow-up than participants in interventions for the promotion of a healthy lifestyle that will include counselling plus physical exercise of low-to-moderate intensity or interventions based exclusively on counselling

It is a three arms controlled randomized clinical trial implemented in the Primary Health Care setting and of 10 months duration
Detailed Description: The purpose of this study is evaluate the effectiveness of different doses of supervised exercise training intensity -concomitant to lifestyle counselling- as a Primary Health Care intervention tool for the management of the metabolic syndrome in low active adults with one or more metabolic risk factors

Secondary aims of the study are to investigate the effects of these interventions on systemic inflammation and adipose tissue function cardiorespiratory fitness physical activity and sedentary habits and the cost-effectiveness of the intervention with regard to health related quality of life

The general hypothesis is that adults with risk factors for metabolic syndrome participating in interventions for the promotion of a healthy lifestyle that together with counselling strategies will include supervised physical exercise of vigorous intensity will present greater improvements in terms of metabolic risk physical condition physical activitysedentary behaviours and psychological parameters at the end of the intervention and at 6-months follow-up than participants in interventions for the promotion of a healthy lifestyle that will include counselling plus physical exercise of low-to-moderate intensity or interventions based exclusively on counselling

It is a three arms controlled randomized clinical trial implemented in the Primary Health Care setting and of 10 months duration

Adults aged 30 to 52 years with metabolic risk factors will be randomized in three intervention groups that will be given one of the following assessment on healthy lifestyle plus high intensity physical exercise supervision 3 individual and 6 group sessions 16 supervised training lessons assessment plus low-to-moderate intensity physical exercise supervision 3 individual and 6 group sessions 16 supervised training lessons or assessment-based programme without physical exercise supervision 3 individual and 6 group sessions

The main output variables evaluated will be a risk factors for the metabolic syndrome waist circumference blood pressure and plasma triglycerides high density lipoproteins and glucose systemic inflammation and adipose tissue functionality physical activity habits and sedentary conducts dietary habits quality of life related to health self-efficacy and empowerment The economic cost will also be analysed to determine the cost-effectiveness of the program These variables will be assessed 3 times alongside the study at baseline at the end of the 4 months intervention and at 6 months follow-up It has been estimated to recruit 33 participants per group which are 100 participants

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None