NCT02832453

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

1.3 years

First QC Date

July 6, 2016

Last Update Submit

August 19, 2019

Conditions

Metabolic Syndrome XLifestyle-related ConditionLifestyle Risk ReductionCardiovascular Risk Factor

Keywords

High intensity physical exercisePrimary health careBehaviour change interventions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Change from baseline in cardiorespiratory fitness

    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

    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

    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

    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

    3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.

  • +6 more secondary outcomes

Other Outcomes (1)

  • Cost-effectiveness of the intervention

    4 months

Study Arms (3)

Lifestyle counseling

OTHER

This group will receive lifestyle counselling but not supervised exercise training sessions

Behavioral: Lifestyle

Aerobic interval training

EXPERIMENTAL

This group will receive lifestyle counselling plus supervised high intensity (80%VO2max) interval exercise training sessions

Behavioral: LifestyleBehavioral: Aerobic interval training

Traditional continous training

ACTIVE COMPARATOR

This group will receive lifestyle counselling plus supervised moderate intensity (60%VO2max) continous exercise training sessions

Behavioral: LifestyleBehavioral: Traditional continous training

Interventions

LifestyleBEHAVIORAL

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.

Aerobic interval trainingLifestyle counselingTraditional continous training
Aerobic interval trainingBEHAVIORAL

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 .

Aerobic interval training
Traditional continous trainingBEHAVIORAL

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.

Traditional continous training

Eligibility Criteria

Age30 Years - 52 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INEFC-Lleida

Lleida, 25192, Spain

Location

Related Publications (2)

  • 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.

    PMID: 32531762DERIVED

  • 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.

    PMID: 28292282DERIVED

MeSH Terms

Conditions

Metabolic SyndromeMental DisordersRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Study Officials

  • Assumpta Ensenyat, MD, PhD

    INEFC-Lleida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Assumpta Ensenyat (MD, PhD) Exercise Physiology

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 14, 2016

Study Start

February 1, 2016

Primary Completion

June 1, 2017

Study Completion

December 31, 2017

Last Updated

August 21, 2019

Record last verified: 2019-08

Locations

ES(1)