NCT02832453

Metabolic Risk Management, Physical Exercise and Lifestyle Counselling in Low-active Adults; Controlled Randomized Trial

Supervised Physical Exercise and Lifestyle Counselling in the Management of Metabolic Risk in Low-active Adults; a Controlled Randomized Trial. Belluga't de CAP a Peus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: INEFC-Lleida · Academic / Other
• Sex: All
• Age: 30 Years – 52 Years
• Healthy volunteers: Not accepted

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 activity/sedentary 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 activity/sedentary 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.

Conditions

• Metabolic Syndrome X
• Lifestyle-related Condition
• Lifestyle Risk Reduction
• Cardiovascular Risk Factor

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle	The counselling program consists of 6 group meetings of 1 hour and 3 individual consultations of at least 15 minutes each. Sessions will be set up with the aim to enhance knowledge and empowerment related to physical activity, sedentary conducts, dietary habits, as well as strategies for behaviour change will be given. Individual consultations will focus on establishing realistic objectives and to involve the participants in taking decisions.
BEHAVIORAL	Aerobic interval training	The supervised aerobic interval training will consist of 16 supervised group training lessons lasting 60 minutes and 32 individual nonsupervised training lessons that would be self-administered by each participant. The main part of the training lessons will consist of 4 series of 4 minutes of cycling at a heart rate of 80% of the VO2peak interspersed with active pauses of 2 minutes at 60% of the VO2peak .
BEHAVIORAL	Traditional continous training	The supervised traditional continous training will consist of 16 supervised group training lessons lasting 60 minutes and 32 individual nonsupervised training lessons that would be self-administered by each participant. The main part of the training lessons will consist of activities such as walking, cycling, or tonification exercises always at an intensity of 60% of the VO2peak.

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-06-01
• Completion: 2017-12-31
• First posted: 2016-07-14
• Last updated: 2019-08-21

Locations

1 site across 1 country: Spain