Clinical trial NCT02832453: Metabolic Risk Management, Physical Exercise and Lifestyle Counselling in Low-active Adults; Controlled Randomized Trial
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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome X
Lifestyle-related Condition
Lifestyle Risk Reduction
Cardiovascular Risk Factor
Keywords: High intensity physical exercise
Primary health care
Behaviour change interventions
Lead sponsor: INEFC-Lleida
Sponsor class: OTHER
Collaborators: name: Institut Català de la Salut
name: Universitat de Lleida
name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
First posted: 2016-07-14
Enrollment: 77
Sex: ALL
Minimum age (years): 30
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in metabolic risc score
timeFrame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Secondary outcomes:
measure: Change from baseline in cardiorespiratory fitness
timeFrame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
measure: Change from baseline in active lifestyle
timeFrame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
measure: Change from baseline in sedentary time
timeFrame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
measure: Change from baseline in dietary habits
timeFrame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
measure: Change from baseline in physical activity self-efficacy questionnaire
timeFrame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
measure: Change from baseline in empowerment
timeFrame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
measure: Change from baseline in health related quality of life at the end of the intervention
timeFrame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
measure: Change from baseline in health related quality of life
timeFrame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
measure: Change from baseline in interleucin-6
timeFrame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
measure: Change from baseline in adiponectin
timeFrame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
measure: Change from baseline in plasma metabolome
timeFrame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Other outcomes:
measure: Cost-effectiveness of the intervention
timeFrame: 4 months
Locations:
city: Lleida
country: Spain
facility: INEFC-Lleida
Study officials:
affiliation: INEFC-Lleida
name: Assumpta Ensenyat, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.