Efficacy and Effectiveness of Clinical Trials Applied to the Treatment of Obesity: A Systematic Review

Authors

  • Greice Westphal-Nardo Healthy Active Living and Obesity Research Group, Children’s Hospital of Eastern Ontario Research Institute https://orcid.org/0000-0001-9107-0108
  • Braulio Henrique Magnani Branco Cesumar University
  • Jean-Philippe Chaput Healthy Active Living and Obesity Research Group, Children’s Hospital of Eastern Ontario Research Institute https://orcid.org/0000-0002-5607-5736
  • Nelson Nardo Junior Center for Multiprofessional Studies on Obesity—NEMO/HUM/UEM, University Hospital of Maringa, State University of Maringa,

DOI:

https://doi.org/10.47197/retos.v53.102361

Keywords:

Obesidad, Tratamiento, Eficacia, Efectividad

Abstract

The multidisciplinary treatment of obesity (MTO) has been recognized as the standard intervention and the basis for complementary treatments. However, it is still not clear how effective MTO programs can be and it has become more difficult to determine because normally the conditions of the intervention are not clearly stated. Therefore, it is important to make it clear if one MTO program is characterized as an efficacy trial, conducted under ideal conditions, or as an effectiveness trial developed in real-world scenarios. In this sense, this systematic review aims to explore some information from MTO studies. This systematic review made a search for potential papers using PubMed and SciELO, in which the terms efficacy or effectiveness were presented. After applying all the inclusion/exclusion criteria, four trials were included (343 participants). All the studies had characteristics of effectiveness trials. They used three different main outcomes, which made comparisons difficult. In conclusion, this review shows that a very small number of MTO studies have been published using the terminology efficacy or effectiveness. These studies do not explore the terms in a way that could make important distinctions among these distinct clinical trial models.

Keywords: Obesity; Treatment; Efficacy; Effectiveness.

Author Biographies

Greice Westphal-Nardo , Healthy Active Living and Obesity Research Group, Children’s Hospital of Eastern Ontario Research Institute

PhD in Physical Education by the Associated Graduate Program in Physical Education UEM / UEL (2023) - in the area of concentration Human Performance and Physical Activity. In 2021 and 2022, she was a Researcher at the University of Ottawa with a CAPES scholarship from the Sandwich Doctorate Program Abroad - PDSE-CAPES in the city of Ottawa - Canada, at the Ottawa Hospital Research Institute and Children's Hospital of Eastern Ontario - CHEO, in the Healthy Active Living and Obesity Research Group - HALO. She is currently a Researcher at the Center for Multiprofessional Obesity Studies (NEMO). She is a member of the Canadian Obesity Network (CON). She was Engagement Coordinator in the program Optimizing the Treatment and Management of Obesity (OPTiMO) in partnership with MDBriefCase, in Toronto-Canada. She works mainly on the following topics: Obesity, Exercise Physiology, Evaluation and Functional Rehabilitation, Physical Activity, Cardiometabolic Risk, Research Methodology and Biostatistics.

Braulio Henrique Magnani Branco , Cesumar University

Possui licenciatura plena em Educação Física pela Universidade Estadual de Maringá (UEM) em 2005, bacharelado em Nutrição pela Universidade Cesumar (2021), mestrado em Ciências da Saúde pela UEM (2011) e doutorado em Ciências, pela Escola de Educação Física e Esporte da Universidade de São Paulo (EEFE-USP - 2016). Concluiu o pós-doutoramento no Centro de Investigação em Atividade Física, Saúde e Lazer (CIAFEL) na Faculdade de Desporto da Universidade do Porto em 2023. Atualmente, é professor associado da Universidade Cesumar e docente permanente do Programa de Pós-Graduação em Promoção da Saúde, em nível mestrado e doutorado, pela mesma instituição. É pesquisador do Instituto Cesumar de Ciência, Tecnologia e Inovação (ICETI) e editor adjunto da Revista Saúde e Pesquisa da UniCesumar. É membro da Sociedade Brasileira de Fisiologia e da Associação Brasileira para o Estudo da Obesidade e Síndrome Metabólica (ABESO), da Sociedade Brasileira de Fisiologia (SBFIS) e da Sociedade Brasileira de Atividade Física e Saúde (SBAFS). Apresenta colaborações com pesquisadores brasileiros, chilenos, canadenses, norte-americanos e portugueses. Tem experiência na área de Educação Física, atuando principalmente nos seguintes temas: Promoção da Saúde, Fisiologia do Exercício, Nutrição e Obesidade.

Jean-Philippe Chaput , Healthy Active Living and Obesity Research Group, Children’s Hospital of Eastern Ontario Research Institute

Dr. Chaput is a Senior Scientist with the Healthy Active Living and Obesity Research Group at the Children's Hospital of Eastern Ontario Research Institute and a Professor of Pediatrics at the University of Ottawa. His research focuses on obesity prevention, health promotion, and lifestyle behaviour modification (e.g., improving sleep, increasing physical activity, reducing screen time, and eating better). Dr. Chaput has published more than 400 peer-reviewed scientific articles and is well cited. He serves on many journal editorial boards and advisory committees, has contributed to a large number of conferences around the world (>200 lectures), and received several awards for his research. Outside work he likes to travel, run in the forest, and play with his daughter.

References

Ahern, A. L., Aveyard, P., Boyland, E. J., Halford, J. C. G., & Jebb, S. A. (2016). Inequalities in the uptake of weight management interventions in a pragmatic trial: An observational study in primary care. British Journal of General Practice, 66(645), e258–e263. https://doi.org/10.3399/bjgp16X684337

Alkhatib, A. (2015). Effective Intervention Strategies Combining Mediterranean Diet and Exercise for Reducing Obesi-ty, Metabolic and Cardiovascular Risks in High-Risk Populations: Mini Review. Obesity Research - Open Journal, 1(1), 4–9. https://doi.org/10.17140/OROJ-1-102

Bacon, L., & Aphramor, L. (2011). Weight Science: Evaluating the Evidence for a Paradigm Shift. Nutrition Journal, 10(1), 9. https://doi.org/10.1186/1475-2891-10-9

Bacon, L., Keim, N. L., Van Loan, M. D., Stern, J. S., Gale, B., Kazaks, A., & Stern, J. S. (2002). Evaluating a “non-diet” wellness intervention for improvement of metabolic fitness, psychological well-being and eating and activity behaviors. International Journal of Obesity, 26(6), 854–865. https://doi.org/10.1038/sj.ijo.0802012

Befort, C. A., Kurz, D., Vanwormer, J. J., & Ellerbeck, E. F. (2020). Recruitment and reach in a pragmatic behavioral weight loss randomized controlled trial: Implications for real-world primary care practice. BMC Family Practice, 21(1). https://doi.org/10.1186/s12875-020-01117-w

Berk, K. A., Buijks, H. I. M., Verhoeven, A. J. M., Mulder, M. T., Özcan, B., van ’t Spijker, A., Timman, R., Busschbach, J. J., & Sijbrands, E. J. (2018). Group cognitive behavioural therapy and weight regain after diet in type 2 diabetes: results from the randomised controlled POWER trial. Diabetologia, 61(4), 790–799. https://doi.org/10.1007/s00125-017-4531-9

Blunt, W., Gill, D. P., Sibbald, S. L., Riggin, B., Pulford, R. W., Scott, R., Danylchuk, K., Gray, C. M., Wyke, S., Bunn, C., & Petrella, R. J. (2017). Optimization of the Hockey Fans in Training (Hockey FIT) weight loss and healthy lifestyle program for male hockey fans. BMC Public Health, 17(1), 1–11. https://doi.org/10.1186/s12889-017-4926-z

Bray, G. A., Kim, K. K., & Wilding, J. P. H. (2017). Obesity: a chronic relapsing progressive disease process. A posi-tion statement of the World Obesity Federation. Obesity Reviews, 18(7), 715–723. https://doi.org/10.1111/obr.12551

Bunn, C., Donnachie, C., Wyke, S., Hunt, K., Brennan, G., Lennox, J., Maclean, A., & Gray, C. M. (2018). Can professional football clubs deliver a weight management programme for women: A feasibility study. BMC Public Health, 18(1), 1–13. https://doi.org/10.1186/s12889-018-6255-2

Cleo, G., Beller, E., Glasziou, P., Isenring, E., & Thomas, R. (2020). Efficacy of habit-based weight loss interventions: a systematic review and meta-analysis. Journal of Behavioral Medicine, 43(4), 519–532. https://doi.org/10.1007/s10865-019-00100-w

Dal-Ré, R., Janiaud, P., & Ioannidis, J. P. A. (2018). Real-world evidence: How pragmatic are randomized controlled trials labeled as pragmatic? BMC Medicine, 16(1), 1–6. https://doi.org/10.1186/s12916-018-1038-2

De Miguel-Etayo, P., Moreno, L. A., Santabárbara, J., Bueno, G., Martín-Matillas, M., Zapatera, B., Julián, C. A. S., Martí, A., Campoy, C., Marcos, A., & Garagorri, J. M. (2015). Cambios de composiciÓn corporal durante el tra-tamiento multidisciplinar en adolescentes obesos: Estudio Evasyon. Nutricion Hospitalaria, 32(6), 2525–2534. https://doi.org/10.3305/nh.2015.32.6.9663

Do Prado, W. L., Siegfried, A., Dâmaso, A. R., Carnier, J., De Piano, A., & Siegfried, W. (2009). Effects of long-term multidisciplinary inpatient therapy on body composition of severely obese adolescents. Jornal de Pediatria, 85(3), 243–248. https://doi.org/10.2223/JPED.1889

Enrique, B., & Marta, B. (2020). Efficacy, Effectiveness and Efficiency in the Health Care: The Need for an Agreement to Clarify its Meaning. International Archives of Public Health and Community Medicine, 4(1). https://doi.org/10.23937/2643-4512/1710035

Ferrari, G. D., Azevedo, M., Medeiros, L., Neufeld, C. B., Ribeiro, R. P. P., Rangé, B. P., & Bueno Júnior, C. R. (2017). A multidisciplinary weight-loss program: the importance of psychological group therapy. Motriz: Revista de Educação Física, 23(1), 47–52. https://doi.org/10.1590/s1980-6574201700010007

Ford, I., & Norrie, J. (2016). Pragmatic Trials. New England Journal of Medicine, 375(5), 454–463. https://doi.org/10.1056/nejmra1510059

Fritz, J. M., & Cleland, J. (2003). Effectiveness Versus Efficacy: More Than a Debate Over Language. Journal of Or-thopaedic & Sports Physical Therapy, 33(4), 163–165. https://doi.org/10.2519/jospt.2003.33.4.163

Gomes, P. P., Lofrano-Prado, M. C., Lira, C. T. C. de, Tenório, T. R. dos S., Botero, J. P., Santos, M. A. M. dos, & Prado, W. L. do. (2018). AEROBIC TRAINING IN OBESE ADOLESCENTS: A MULTIDISCIPLINARY AP-PROACH. Revista Brasileira de Medicina Do Esporte, 24(4), 280–285. https://doi.org/10.1590/1517-869220182404184265

Jensen, M. D., Ryan, D. H., Apovian, C. M., Ard, J. D., Comuzzie, A. G., Donato, K. A., Hu, F. B., Hubbard, V. S., Jakicic, J. M., Kushner, R. F., Loria, C. M., Millen, B. E., Nonas, C. A., Pi-Sunyer, F. X., Stevens, J., Stevens, V. J., Wadden, T. A., Wolfe, B. M., & Yanovski, S. Z. (2014). 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: A report of the American College of cardiology/American Heart Association task force on practice guidelines and the obesity society. Circulation, 129(25 SUPPL. 1), 102–138. https://doi.org/10.1161/01.cir.0000437739.71477.ee

Katzmarzyk, P. T., Martin, C. K., Newton, R. L., Apolzan, J. W., Arnold, C. L., Davis, T. C., Price-Haywood, E. G., Denstel, K. D., Mire, E. F., Thethi, T. K., Brantley, P. J., Johnson, W. D., Fonseca, V., Gugel, J., Kennedy, K. B., Lavie, C. J., Sarpong, D. F., & Springgate, B. (2020). Weight Loss in Underserved Patients — A Cluster-Randomized Trial. New England Journal of Medicine, 383(10), 909–918. https://doi.org/10.1056/NEJMoa2007448

Lindahl, B., Söderberg, S., Widman, L., Johnson, O., Hallmans, G., Jansson, J. H., Nilssön, T. K., Borch-Johnsen, K., & Røder, M. E. (2009). A randomized lifestyle intervention with 5-year follow-up in subjects with impaired glucose tolerance: Pronounced short-term impact but long-term adherence problems. Scandinavian Journal of Public Health, 37(4), 434–442. https://doi.org/10.1177/1403494808101373

Looijmans, A., Jörg, F., Bruggeman, R., Schoevers, R., & Corpeleijn, E. (2017). Design of the Lifestyle Interventions for severe mentally ill Outpatients in the Netherlands (LION) trial; a cluster randomised controlled study of a mul-tidimensional web tool intervention to improve cardiometabolic health in patients with severe mental i. BMC Psy-chiatry, 17(1), 1–13. https://doi.org/10.1186/s12888-017-1265-7

López-Padrós, C., Salord, N., Alves, C., Vilarrasa, N., Gasa, M., Planas, R., Montsserrat, M., Virgili, M. N., Rodrí-guez, C., Pérez-Ramos, S., López-Cadena, E., Ramos, M. I., Dorca, J., & Monasterio, C. (2020). Effectiveness of an intensive weight-loss program for severe OSA in patients undergoing CPAP treatment: a randomized controlled trial. Journal of Clinical Sleep Medicine, 16(4), 503–514. https://doi.org/10.5664/jcsm.8252

Madigan, C. D., Graham, H. E., Sturgiss, E., Kettle, V. E., Gokal, K., Biddle, G., Taylor, G. M. J., & Daley, A. J. (2022). Effectiveness of weight management interventions for adults delivered in primary care: systematic review and meta-analysis of randomised controlled trials. BMJ, e069719. https://doi.org/10.1136/bmj-2021-069719

National Heart and Institute. (2014). Study Quality Assessment Tools. Https://Www.Nhlbi.Nih.Gov/Health-Topics/Study-Quality-Assessment-Tools.

Page, M. J., McKenzie, J. E., Bossuyt, P. M., Boutron, I., Hoffmann, T. C., Mulrow, C. D., Shamseer, L., Tetzlaff, J. M., Akl, E. A., Brennan, S. E., Chou, R., Glanville, J., Grimshaw, J. M., Hróbjartsson, A., Lalu, M. M., Li, T., Loder, E. W., Mayo-Wilson, E., McDonald, S., … Moher, D. (2021). The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ, n71. https://doi.org/10.1136/bmj.n71

Reynolds, K. D., & Spruijt-Metz, D. (2006). Translational Research in Childhood Obesity Prevention. Evaluation & the Health Professions, 29(2), 219–245. https://doi.org/10.1177/0163278706287346

Ritzwoller, D. P., Glasgow, R. E., Sukhanova, A. Y., Bennett, G. G., Warner, E. T., Greaney, M. L., Askew, S., Goldman, J., Emmons, K. M., & Colditz, G. A. (2013). Economic analyses of the be fit be well program: A weight loss program for community health centers. Journal of General Internal Medicine, 28(12), 1581–1588. https://doi.org/10.1007/s11606-013-2492-3

Shaw, P. A., Jr, W. S. Y., Wesby, L., Ulrich, V., Huffman, D., Foster, G. D., Volpp, K., Economics, B., Affairs, V., International, W. W., Veterans, P., & Medical, A. (2018). The design and conduct of Keep It Off: An online ran-domized trial of financial incentives for weight loss maintenance. 14(1), 29–36. https://doi.org/10.1177/1740774516669679.

The Singal, A. G., Higgins, P. D. R., & Waljee, A. K. (2014). A Primer on Effectiveness and Efficacy Trials. Clinical and Translational Gastroenterology, 5(1), e45. https://doi.org/10.1038/ctg.2013.13

Sussman, S., Valente, T. W., Rohrbach, L. A., Skara, S., & Ann Pentz, M. (2006). Translation in the Health Profes-sions. Evaluation & the Health Professions, 29(1), 7–32. https://doi.org/10.1177/0163278705284441

Westphal, G., Chaput, J.-P., & Nardo Junior, N. (2022). PROSPERO International prospective register of systematic reviews Citation.

Westphal, G., Faúndez-Casanova, C., Ferraz Grizzo, F. M., Mendes, A. A., Oltramari, K., Pascoini, M., Castillo-Retamal, M., Souza de Carvalho, R., Vásquez-Gómez, J., & Nardo Junior, N. (2023). Perfil de composición cor-poral y estado nutricional de adolescentes con sobrepeso u obesidad mediante indicadores habituales e inusuales (Body Composition Profile and Nutritional Status of Adolescents with Overweight or Obesity Using Usual and Unusual Indicators). Retos, 50, 1108–1114. https://doi.org/10.47197/retos.v50.99242

Westphal-Nardo, G., Chaput, J.-P., Faúndez-Casanova, C., Fernandes, C. A. M., de Andrade Gonçalves, E. C., Utri-la, R. T., Oltramari, K., Grizzo, F. M. F., & Nardo-Junior, N. (2023). Exploring New Tools for Risk Classification among Adults with Several Degrees of Obesity. International Journal of Environmental Research and Public Health, 20(13), 6263. https://doi.org/10.3390/ijerph20136263

Wharton, S., Lau, D. C. W., Vallis, M., Sharma, A. M., Biertho, L., Campbell-Scherer, D., Adamo, K., Alberga, A., Bell, R., Boulé, N., Boyling, E., Brown, J., Calam, B., Clarke, C., Crowshoe, L., Divalentino, D., Forhan, M., Freedhoff, Y., Gagner, M., … Wicklum, S. (2020). Obesity in adults: a clinical practice guideline. Canadian Medi-cal Association Journal, 192(31), E875–E891. https://doi.org/10.1503/cmaj.191707

Williams, H. C., Burden-Teh, E., & Nunn, A. J. (2015). What is a pragmatic clinical trial? Journal of Investigative Dermatology, 135(6), 1–3. https://doi.org/10.1038/jid.2015.134

Wing, R. R., Lang, W., Wadden, T. A., Safford, M., Knowler, W. C., Bertoni, A. G., Hill, J. O., Brancati, F. L., Peters, A., & Wagenknecht, L. (2011). Benefits of Modest Weight Loss in Improving Cardiovascular Risk Factors in Overweight and Obese Individuals With Type 2 Diabetes. Diabetes Care, 34(7), 1481–1486. https://doi.org/10.2337/dc10-2415

World Obesity. (2020). Obesity: missing the 2025 global targets. World Obesity Federation, 12–32. https://data.worldobesity.org/publications/?cat=2

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Published

2024-04-01

How to Cite

Westphal-Nardo, G., Magnani Branco, B. H., Chaput, J.-P., & Nardo Junior, N. (2024). Efficacy and Effectiveness of Clinical Trials Applied to the Treatment of Obesity: A Systematic Review. Retos, 53, 628–635. https://doi.org/10.47197/retos.v53.102361

Issue

Vol. 53 (2024)

Section

Theoretical systematic reviews and/or meta-analysis

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