Metabolic Risk Management, Physical Exercise and Lifestyle Counselling in Low-active Adults; Controlled Randomized Trial (BELLUGAT)
Primary Purpose
Metabolic Syndrome X, Lifestyle-related Condition, Lifestyle Risk Reduction
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Lifestyle
Aerobic interval training
Traditional continous training
Sponsored by
![INEFC-Lleida](https://trials-media.s3.amazonaws.com/orgs/inefc-lleida.jpeg)
About this trial
This is an interventional treatment trial for Metabolic Syndrome X focused on measuring High intensity physical exercise, Primary health care, Behaviour change interventions
Eligibility Criteria
Inclusion Criteria:
- Low active (achieving less than 150 minutes/week of moderate-to-vigorous physical activity or have not participated in any supervised exercise programs for at least the last 6 months).
- Having one or more risk factors for metabolic syndrome (Marcuello et al., 2013) (waist circumference >94.5 cm for men and >89.5 cm for women; blood pressure ≥130/85 mmHg; triglycerides in plasma ≥150 mg/dL; high density lipoprotein cholesterol in plasma <40 mg/dL for men and <50 mg/dL for women; fasting glycaemia ≥100 mg/dL).
- Accept and sign the written informed consent.
- Accept the randomized group assignment.
Exclusion Criteria:
- Couples or individuals living in the same house
- Morbid obesity (BMI ≥ 40).
- A past/current history and/or physical examination or laboratory findings of significant diseases of cardiovascular, respiratory, neuromuscular, psychiatric diseases/disorders.
- Diseases/disorders that may contraindicate performing physical exercise or a stress test.
Sites / Locations
- INEFC-Lleida
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Active Comparator
Arm Label
Lifestyle counseling
Aerobic interval training
Traditional continous training
Arm Description
This group will receive lifestyle counselling but not supervised exercise training sessions
This group will receive lifestyle counselling plus supervised high intensity (80%VO2max) interval exercise training sessions
This group will receive lifestyle counselling plus supervised moderate intensity (60%VO2max) continous exercise training sessions
Outcomes
Primary Outcome Measures
Change from baseline in metabolic risc score
A continuous metabolic syndrome risk score (cMSSy) will be calculated as described by Wijndaele (Wijndaele et al., 2006). The score contains the five risk factors considered in the definition of the metabolic syndrome (Expert panel on detection, 2001; Marcuello et al., 2013), that is waist circumference, triglycerides, high density lipoproteins cholesterol, systolic blood pressure and plasma glucose.
Secondary Outcome Measures
Change from baseline in cardiorespiratory fitness
Improvement of peak oxygen uptake (VO2peak). Cardiorespiratory fitness will be assessed by means of voluntary maximal graded exercise on a cycle ergometer while measuring oxygen consumption (VO2).
Change from baseline in active lifestyle
Daily time spent at moderate-to-vigorous physical activity. Participants will wear Actigraph accelerometers (GT3X+ models) during all day for seven consecutive days. Cut points for moderate-to-vigorous physical activity will be set above 2020 counts per minute.
Change from baseline in sedentary time
Reduction of the daily time devoted to sedentary conducts. Participants will wear Actigraph accelerometers (GT3X+ models) during all day for seven consecutive days. Cut points for sedentary conducts will be set under 100 counts per minute.
Change from baseline in dietary habits
Improvement of healthy eating index
Change from baseline in physical activity self-efficacy questionnaire
Spanish version of the physical activity scale (Fernández-Cabrera, Medina, Rueda, Ordoñez, & León, 2012)
Change from baseline in empowerment
Health Empowerment Scale (HES) (Serrani, 2014)
Change from baseline in health related quality of life at the end of the intervention
Quality of life questionaire (EQ-5D)
Change from baseline in health related quality of life
Quality of life questionaire (EQ-5D)
Change from baseline in interleucin-6
Fasting blood samples will be drawn to determine interleukin by cytometry.
Change from baseline in adiponectin
Fasting blood samples will be drawn to determine adiponectin by cytometry.
Change from baseline in plasma metabolome
Fasting blood samples will be drawn to determine plasma metabolome.
Full Information
NCT ID
NCT02832453
First Posted
July 6, 2016
Last Updated
August 19, 2019
Sponsor
INEFC-Lleida
Collaborators
Institut Català de la Salut, Universitat de Lleida, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
1. Study Identification
Unique Protocol Identification Number
NCT02832453
Brief Title
Metabolic Risk Management, Physical Exercise and Lifestyle Counselling in Low-active Adults; Controlled Randomized Trial
Acronym
BELLUGAT
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
INEFC-Lleida
Collaborators
Institut Català de la Salut, Universitat de Lleida, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X, Lifestyle-related Condition, Lifestyle Risk Reduction, Cardiovascular Risk Factor
Keywords
High intensity physical exercise, Primary health care, Behaviour change interventions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle counseling
Arm Type
Other
Arm Description
This group will receive lifestyle counselling but not supervised exercise training sessions
Arm Title
Aerobic interval training
Arm Type
Experimental
Arm Description
This group will receive lifestyle counselling plus supervised high intensity (80%VO2max) interval exercise training sessions
Arm Title
Traditional continous training
Arm Type
Active Comparator
Arm Description
This group will receive lifestyle counselling plus supervised moderate intensity (60%VO2max) continous exercise training sessions
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic interval training
Intervention Description
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 .
Intervention Type
Behavioral
Intervention Name(s)
Traditional continous training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in metabolic risc score
Description
A continuous metabolic syndrome risk score (cMSSy) will be calculated as described by Wijndaele (Wijndaele et al., 2006). The score contains the five risk factors considered in the definition of the metabolic syndrome (Expert panel on detection, 2001; Marcuello et al., 2013), that is waist circumference, triglycerides, high density lipoproteins cholesterol, systolic blood pressure and plasma glucose.
Time Frame
3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Secondary Outcome Measure Information:
Title
Change from baseline in cardiorespiratory fitness
Description
Improvement of peak oxygen uptake (VO2peak). Cardiorespiratory fitness will be assessed by means of voluntary maximal graded exercise on a cycle ergometer while measuring oxygen consumption (VO2).
Time Frame
3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Title
Change from baseline in active lifestyle
Description
Daily time spent at moderate-to-vigorous physical activity. Participants will wear Actigraph accelerometers (GT3X+ models) during all day for seven consecutive days. Cut points for moderate-to-vigorous physical activity will be set above 2020 counts per minute.
Time Frame
3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Title
Change from baseline in sedentary time
Description
Reduction of the daily time devoted to sedentary conducts. Participants will wear Actigraph accelerometers (GT3X+ models) during all day for seven consecutive days. Cut points for sedentary conducts will be set under 100 counts per minute.
Time Frame
3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Title
Change from baseline in dietary habits
Description
Improvement of healthy eating index
Time Frame
3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Title
Change from baseline in physical activity self-efficacy questionnaire
Description
Spanish version of the physical activity scale (Fernández-Cabrera, Medina, Rueda, Ordoñez, & León, 2012)
Time Frame
3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Title
Change from baseline in empowerment
Description
Health Empowerment Scale (HES) (Serrani, 2014)
Time Frame
3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Title
Change from baseline in health related quality of life at the end of the intervention
Description
Quality of life questionaire (EQ-5D)
Time Frame
3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Title
Change from baseline in health related quality of life
Description
Quality of life questionaire (EQ-5D)
Time Frame
3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Title
Change from baseline in interleucin-6
Description
Fasting blood samples will be drawn to determine interleukin by cytometry.
Time Frame
3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Title
Change from baseline in adiponectin
Description
Fasting blood samples will be drawn to determine adiponectin by cytometry.
Time Frame
3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Title
Change from baseline in plasma metabolome
Description
Fasting blood samples will be drawn to determine plasma metabolome.
Time Frame
3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Other Pre-specified Outcome Measures:
Title
Cost-effectiveness of the intervention
Description
Direct and indirect costs of setting and running the interventions will be collected for the economic evaluation analysis by means of questionnaires. HRQoL scores will be used to weight survival years and generate quality adjusted life years (QALYs ). The cost-effectiveness analysis will be conducted according to the current practice methods for economic evaluation (Frew et al., 2014).
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Low active (achieving less than 150 minutes/week of moderate-to-vigorous physical activity or have not participated in any supervised exercise programs for at least the last 6 months).
Having one or more risk factors for metabolic syndrome (Marcuello et al., 2013) (waist circumference >94.5 cm for men and >89.5 cm for women; blood pressure ≥130/85 mmHg; triglycerides in plasma ≥150 mg/dL; high density lipoprotein cholesterol in plasma <40 mg/dL for men and <50 mg/dL for women; fasting glycaemia ≥100 mg/dL).
Accept and sign the written informed consent.
Accept the randomized group assignment.
Exclusion Criteria:
Couples or individuals living in the same house
Morbid obesity (BMI ≥ 40).
A past/current history and/or physical examination or laboratory findings of significant diseases of cardiovascular, respiratory, neuromuscular, psychiatric diseases/disorders.
Diseases/disorders that may contraindicate performing physical exercise or a stress test.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assumpta Ensenyat, MD, PhD
Organizational Affiliation
INEFC-Lleida
Official's Role
Principal Investigator
Facility Information:
Facility Name
INEFC-Lleida
City
Lleida
ZIP/Postal Code
25192
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
At present we have not planned to share data. Probably at the end of the trail we will put them on the repository of the University of Lleida.
Citations:
PubMed Identifier
32531762
Citation
Ensenyat A, Espigares-Tribo G, Machado-Da-Silva L, Sinfreu-Bergues X, Blanco A. Semisupervised Physical Exercise and Lifestyle Counseling in Cardiometabolic Risk Management in Sedentary Adults: Controlled Randomized Trial (BELLUGAT). J Phys Act Health. 2020 Jun 12;17(7):744-755. doi: 10.1123/jpah.2019-0409.
Results Reference
derived
PubMed Identifier
28292282
Citation
Ensenyat A, Espigares-Tribo G, Machado L, Verdejo FJ, Rodriguez-Arregui R, Serrano J, Miret M, Galindo G, Blanco A, Marsal JR, Sarriegui S, Sinfreu-Bergues X, Serra-Paya N. Metabolic risk management, physical exercise and lifestyle counselling in low-active adults: controlled randomized trial (BELLUGAT). BMC Public Health. 2017 Mar 14;17(1):257. doi: 10.1186/s12889-017-4144-8.
Results Reference
derived
Learn more about this trial
Metabolic Risk Management, Physical Exercise and Lifestyle Counselling in Low-active Adults; Controlled Randomized Trial
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