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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Risk Factor; Metabolic Syndrome X; Lifestyle-related Condition; Lifestyle Risk Reduction
• Intervention / Treatment: Behavioral: Lifestyle; Behavioral: Aerobic interval training; Behavioral: Traditional continous training

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.

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Lleida, Spain, 25192
    • INEFC-Lleida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 52 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lifestyle counseling; This group will receive lifestyle counselling but not supervised exercise training sessions	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.
Experimental: Aerobic interval training; This group will receive lifestyle counselling plus supervised high intensity (80%VO2max) interval exercise training sessions	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 .
Active Comparator: Traditional continous training; This group will receive lifestyle counselling plus supervised moderate intensity (60%VO2max) continous exercise training sessions	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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
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.	3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
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.	3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in dietary habits	Improvement of healthy eating index	3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in physical activity self-efficacy questionnaire	Spanish version of the physical activity scale (Fernández-Cabrera, Medina, Rueda, Ordoñez, & León, 2012)	3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in empowerment	Health Empowerment Scale (HES) (Serrani, 2014)	3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in health related quality of life at the end of the intervention	Quality of life questionaire (EQ-5D)	3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in health related quality of life	Quality of life questionaire (EQ-5D)	3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in interleucin-6	Fasting blood samples will be drawn to determine interleukin by cytometry.	3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in adiponectin	Fasting blood samples will be drawn to determine adiponectin by cytometry.	3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in plasma metabolome	Fasting blood samples will be drawn to determine plasma metabolome.	3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness of the intervention	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).	4 months

Collaborators and Investigators

• Sponsor: INEFC-Lleida
• Collaborators: Institut Català de la Salut; Universitat de Lleida; Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Investigators: Principal Investigator: Assumpta Ensenyat, MD, PhD, INEFC-Lleida

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: July 6, 2016
• First Submitted That Met QC Criteria: July 13, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Actual): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Primary health care; High intensity physical exercise; Behaviour change interventions
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: 2014-PINEFC00003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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.