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Published in: BMC Public Health 1/2017

Open Access 01-12-2017 | Study protocol

Metabolic risk management, physical exercise and lifestyle counselling in low-active adults: controlled randomized trial (BELLUGAT)

Authors: Assumpta Ensenyat, Gemma Espigares-Tribo, Leonardo Machado, Francisco José Verdejo, Rosa Rodriguez-Arregui, José Serrano, Marta Miret, Gisela Galindo, Alfonso Blanco, Josep-Ramon Marsal, Susana Sarriegui, Xenia Sinfreu-Bergues, Noemi Serra-Paya

Published in: BMC Public Health | Issue 1/2017

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Abstract

Background

The primary aim of this study is to evaluate the effectiveness of different doses (intensity) of supervised exercise training — concomitant with lifestyle counselling — as a primary care intervention tool for the management of metabolic syndrome risk factors in low-active adults with one or more such factors (programme name in Catalan: Bellugat de CAP a peus).

Methods/Design

Three-arm, randomized controlled clinical trial implemented in the primary care setting, with a duration of 40 weeks (16 weeks intervention and 24-week follow-up).
Adults aged 30 to 55 years with metabolic risk factors will be randomized into three intervention groups: 1) aerobic interval training (16 supervised training lessons) plus a healthy lifestyle counselling programme (6 group and 3 individual meetings); 2) low-to-moderate intensity continuous training (16 supervised training lessons) plus the same counselling programme; or 3) the counselling- programme without any supervised physical exercise.
The main output variables assessed will be risk factors for metabolic syndrome (waist circumference, blood pressure, and levels of plasma triglycerides, high-density lipoproteins and glucose), systemic inflammation, cardiorespiratory fitness, physical activity and sedentary behaviour, dietary habits, health-related quality of life, self-efficacy and empowerment. Economic factors will also be analysed in order to determine the cost-effectiveness of the programme. These variables will be assessed three times during the study: at baseline, at the end of the intervention, and at follow-up. We estimate to recruit 35 participants per group.

Discussion

The results of this study will provide insight into the immediate and medium-term effects on metabolic risk and lifestyle of a combined approach involving aerobic interval training and a multidisciplinary behavioural intervention. If effective, the proposed intervention would provide both researchers and practitioners in this field with a platform on which to develop similar intervention programmes for tackling the repercussions of an unhealthy lifestyle.

Trial registration

Clinical trials.gov. NTC02832453. Registered 6 July 2016 (retrospectively registered).
Literature
1.
Marcuello C, Calle-Pascual A, Fuentes M, Runkle I, Rubio M, Montañez C, et al. Prevalence of the metabolic syndrome in Spain using regional cutoff points for waist circumference; the di@bet.es study. Acta Diabetol. 2013;50:615–623.
2.
Bayley A, de Zoysa N, Cook DG, Whincup PH, Stahl D, Twist C, et al. Comparing the effectiveness of an enhanced MOtivational intErviwing InTervention (MOVE IT) with usual care for reducing cardiovascular risk in high risk subjects: study protocol for a randomised controlled trial. Trials. 2015;16:112.CrossRefPubMedPubMedCentral
3.
WHO. Global strategy on diet, physical activity and health. Geneva: WHO; 2004.
4.
European Commission. Special Eurobarometer 412 - Sport and physical activity. Conducted by TNS opinion & social. Brussels: European Commission; 2010.
5.
Pedersen BK, Saltin B. Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports. 2015;25:1–72.CrossRefPubMed
6.
Pattyn N, Cornelissen V, Eshghi RT, Vanhees L. The effect of exercise on the cardiovascular risk factors constituting the metabolic syndrome. Sports Med. 2013;43:121–33.CrossRefPubMed
7.
American College of Sports Medicine. ACSM’s guidelines for exercise testing and prescription. 8th ed. Baltimore (MD): Lippincot Williams & Wilkins; 2010.
8.
Warbuton D, Charlesworth S, Ivey A, Nettlefold L, Bredin S. A systematic review of the evidence for Canada’s physical activity guidelines for adults. International Journal of Behavioral Nutrition and Physical Activity. 2010;7:39.CrossRef
9.
WHO. Global recommendations on physical activity for health. Geneva: WHO Press; 2010.
10.
Rankin A, Rankin A, MacIntyre P, Hillis W. Walk or run? Is high-intensity exercise more effective than moderate intensity exercise at reducing cardiovascular risk? Scott Med J. 2012;57:99–102.
11.
Pattyn N, Coeckelberghs E, Buys R, Cornelissen V, Vanhees L. Aerobic interval training vs moderate continous training in coronary artery disease patients: a systematic reviwe and meta-analysis. Sports Med. 2014;44:687–700.CrossRefPubMed
12.
Arena R, Myers J, Forman D, Lavie C, Guazzi M. Should high-intensity interval training become the clinical standard in heart failure? Heart Failure Reviews. 2013;18:95–105.CrossRefPubMed
13.
Billat LV. Interval training for performance: a scientific and empirical practice. Special recommendations for middle- and long-distance running. Part I: aerobic interval training. Sports Med. 2001;31:13–31.CrossRefPubMed
14.
Helgerud J, Hoydal K, Wang E, Karlsen T, Berg P, Bjerkaas M, et al. Aerobic high-intensity intervals improve VO2max more than moderate training. Med Sci Sports Exerc. 2007;39:665–71.CrossRefPubMed
15.
Moholdt TT, Amundsen BH, Rustad LA, Wahba A, Lovo KT, Gullikstad LR, et al. Aerobic interval training versus continuous moderate exercise after coronary artery bypass surgery: a randomized study of cardiovascular effects and quality of life. Am Heart J. 2009;158:1031–7.CrossRefPubMed
16.
Rognmo O, Hetland E, Helgerud J, Hoff J, Slordahl SA. High intensity aerobic interval exercise is superior to moderate intensity exercise for increasing aerobic capacity in patients with coronary artery disease. Eur J Cardiovasc Prev Rehabil. 2004;11:216–22.CrossRefPubMed
17.
Wisloff U, Stoylen A, Loennechen JP, Bruvold M, Rognmo O, Haram PM, et al. Superior cardiovascular effect of aerobic interval training versus moderate continuous training in heart failure patients: a randomized study. Circulation. 2007;115:3086–94.CrossRefPubMed
18.
Stensvold D, Tjonna AE, Skaug EA, Aspenes S, Stolen T, Wisloff U, et al. Strength training versus aerobic interval training to modify risk factors of metabolic syndrome. J Appl Physiol (1985). 2010;108:804–10.CrossRef
19.
Tjonna AE, Stolen TO, Bye A, Volden M, Slordahl SA, Odegard R, et al. Aerobic interval training reduces cardiovascular risk factors more than a multitreatment approach in overweight adolescents. Clin Sci (Lond). 2009;116:317–26.CrossRef
20.
Tjonna AE, Lee SJ, Rognmo O, Stolen TO, Bye A, Haram PM, et al. Aerobic interval training versus continuous moderate exercise as a treatment for the metabolic syndrome: a pilot study. Circulation. 2008;118:346–54.CrossRefPubMedPubMedCentral
21.
Biddle S, Batterham A. High-intensity interval exercise training for public health: a big HIT or shall we HIT it on the head? International Journal of Behavioral Nutrition and Physical Activity. 2015;12:95.CrossRefPubMedPubMedCentral
22.
Morton JP, Kayani AC, McArdle A, Drust B. The exercise-induced stress response of skeletal muscle, with specific emphasis on humans. Sports Medicine. 2009;39:643–62.CrossRefPubMed
23.
Barlett J, Close G, MacLaren D, Gregson W, Drust B, Morton JP. High-intensity interval running is perceived as more enjoyable than moderate-intensity continuous exercise: implications for exercise adherence. J Sports Sci. 2011;29:547–53.CrossRef
24.
25.
Espigares G, Ensenyat A. Guia per a la promoció d’un estil de vida saludable. Lleida: INEFC; 2015.
26.
Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: Toward an integrative model of change. J Consult Clin Psychol. 1983;51:390–5.CrossRefPubMed
27.
Miller W, Rollnick S. Motivational interviewing: helping people change. 3rd ed. New York: Guilford Press; 2013.
28.
Landeta J. El método Delphi. Barcelona: Ariel; 2000.
29.
Bernier M. Establishing the psycometric properties of a scale for evaluating quality in printed educatioin materials. Berner Institutional Design Scale. Educ Couns. 1996;29:283–99.CrossRef
30.
Doak C, Doak L, Root J. Assessing suitability of materials. In Doak C, Doak L, Root J. Teaching Patients with Low Literacy Skills. Philadelphia: Lippincott; 1996. p. 41–59.
31.
Barrio-Cantalejo I. Los métodos de medición legibilidad y su aplicación al diseño de folletos educativos sobre salud. 2009.
32.
Suni J, Husu P, Rinne M. Fitness for Health: The ALPHA-FIT test battery for adults aged 18–69. Tampere: European Union,DG SANCO, UKK Institute for Health Promotion Research; 2006.
33.
WHO. Waist circumference and waist-to-hip ratio: report of a WHO expert consultation. Edited by WHO. December 2008. 2011. Geneva. 8–11.
34.
Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, et al. Recommendations for blood pressure measurements in humans and experimental animals: part 1: Blood pressure measurements in humans: a statment for professionals from the subcommittee of professional and public education of the american heart associatioin council on high blood pressure research. Circulation. 2005;111:697–716.CrossRefPubMed
35.
Wijndaele K, Beunen G, Duvigneaud N, Matton L, Duquet W, Thomis M, et al. A continuous metabolic syndrome risk score: utility for epidemiological analyses. Diabetes Care. 2006;29:2329.CrossRefPubMed
36.
Expert panel on detection evaluation and treatment of high blood cholesterol in adults: Executive summary of the third report of the national cholesterol education programme (NCEP). JAMA 2001, 285: 2486–2497.
37.
Amato M, Giordano C, Galia M, Criscimanna A, Vitabile S, Miridi M, et al. Visceral adiposity index. A reliable indicator of visceral fat function associated with cardiometabolic risk. Diabetes Care. 2010;33:920–2.CrossRefPubMedPubMedCentral
38.
Frolkis A, Knox C, Lim E, Jewison T, Law V, Hau D, et al. SMPDB: The Small Molecules Pathway Database. Nucleic Acids Res. 2010;38:D480–487.CrossRefPubMed
39.
Jewison T, Su Y, Disfany F, Knox C, Maciejewski A, Poelzer J, et al. SMPDB 2.0: Big Improvements to Small Molecule Pathway Database. Nucleic Acids Res. 2014;42:D478–484.CrossRefPubMed
40.
41.
42.
Dunbar CC, Saul B. ECG interpretation for the clinical exercise physiologist. Baltimore (MD): Lippincott Williams & Wilkins; 2009.
43.
Borg G. Borg’s perceived exertion and pain scales. Champaign, IL: Human Kinetics Publishers; 1998.
44.
Troiano R, Berrigan D, Dodd K, Masse L, Tilert T, McDowel M. Physical activity in the United States measured by accelerometer. Med Sci Sports Exerc. 2008;40:181–8.CrossRefPubMed
45.
Martin-Moreno JM, Boyle P, Gorgojo L, Maisonneuve P, Fernández-Rodriguez JC, Savini S. Development and validation of a food frequency questionnaire in Spain. Int J Epidemiol. 1993;22:512–9.CrossRefPubMed
46.
González-Solanellas M, Romagosa M, Pérez-Portabella A, Zabaleta-del-Olmo E, Grau-Carod M, Casellas-Montagut C, et al. Estudio de prevalencia sobre hábitos alimentarios y estado nutricional en población adulta atendida en atención primaria. Nutr Hosp. 2011;26:337–44.PubMed
47.
Bowman SA, Lino M, Gerrior SA, Basiotis PP. The healthy eating index: 1994–96. In Family Economics and Nutrition Review. Washington DC: U.S Department of Agriculture, Center for Nutrition Policy and Promotion; 1988. p. 2–14.
48.
Basiotis PP, Carlson A, Gerrior SA, Juan WY, Lino M. The Healthy Eating Index 1999–2000. Washington, DC: US Department of Agriculture, Center for Nutrition Policy and Promotion, 2002, CNPP-12.
49.
Serrani D. Elders Health empowerment scale. Spanish adaptation and psychometric analysis. Columbia Médica. 2014;45:179–85.
50.
Bandura A: Guide for constructing self-efficacy scales. In Self-efficacy beliefs of adolescents. Tampere: Informaton Age Publishing; 2006:307–337.
51.
Badia X, Roser M, Montserrat S, Herdman M, Segura A. The spanish version of EuroQol: a description and its applications. European Quality of Life scale. Med Clin (Barc). 1998;112:79–85.
52.
Frew EJ, Bhatti M, Win K, Sitch A, Lyon A, Pallan M, et al. Cost-effectiveness of a community-based physical activity programme for adults (Be active) in UK: an economic analysis within a natural experiment. Br J Sports Med. 2014;48:207–12.CrossRefPubMed
53.
Kendzierski D, DeCarlo K. Physical activity enjoyment scale: two validation studies. Journal of Sport Psychology. 1991;13:50–64.
54.
55.
WHO. 2008–2013 action plan for the global strategy for the prevention and control of non-communicable diseases: prevent and control cardiovascular diseases, cancers, chronic respiratory diseases and diabetes. Edited by WHO Document production services. Geneva: WHO Document production services; 2008.
56.
Myers J, Prakash M, Frelicher V, Do D. Exercise capacity and mortality among men referred for exercise testing. N Engl J Med. 2002;346:793–9.CrossRefPubMed
57.
de Souto BP. Why are we failing to promote physical activity globally? Bull World Health Organ. 2013;91:390–390A.CrossRef
58.
Biddle S, Brehm W, Verheijden M, Hopman-Rock M. Population physical activity behaviour change: a review for the European College of Sport Science. European Journal of Sport Science. 2012;12:367–83.CrossRef
59.
Fischer CP, Berntsen A, Perstrup LB, Eskildsen P, Pedersen BK. Plasma levels of interleukin-6 and C-reactive protein are associated with physical inactivity independent of obesity. Scand J Med Sci Sports. 2007;17:580–7.PubMed
60.
Marrugat J, Vila J, Baena-Díez JM, Grau M, Sala J, Ramos R, et al. Validez relativa de la estimación del riesgo cardiovascular a 10 años en una cohorte poblacional del estudio REGICOR. Rev Esp Cardiol. 2011;64:385–94.CrossRefPubMed
Metadata
Title
Metabolic risk management, physical exercise and lifestyle counselling in low-active adults: controlled randomized trial (BELLUGAT)
Authors
Assumpta Ensenyat
Gemma Espigares-Tribo
Leonardo Machado
Francisco José Verdejo
Rosa Rodriguez-Arregui
José Serrano
Marta Miret
Gisela Galindo
Alfonso Blanco
Josep-Ramon Marsal
Susana Sarriegui
Xenia Sinfreu-Bergues
Noemi Serra-Paya
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2017
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/s12889-017-4144-8

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