An International Perspective on Improving the Quality and Potential of Behavioral Clinical Trials

Abstract

Healthy behaviors (e.g., eating a healthy diet, engaging in regular physical activity, smoking cessation) are associated with a reduction in the incidence and mortality of chronic non-communicable diseases (NCDs), including cardiovascular disease. There have been many examples of health behavior interventions leading to improvements in NCDs and their risk factors, such as hypertension. However, despite their potential benefits, the uptake of existing behavioral interventions has been limited. Among many barriers to implementation of behavioral treatments are concerns about methodological inadequacies. The current manuscript discusses recent advances in frameworks for the development of interventions, the reporting of trials and their protocols, and areas which need further work. The goal of this article is to increase awareness and encourage further debate about how best to promote high-quality behavioral intervention research.

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Acknowledgments

The members of the IBTN (IBTNetwork.org) would like to thank the Canadian Institutes of Health Research—MPE 132280 for the initial funding for the network and Mr. Guillaume Lacoste for overseeing the coordination of the network. In addition, Drs. Bacon and Lavoie both received salary support from the Fonds de Recherche du Quebec—Sante and the Canadian Institutes for Health Research which aid in the maintenance of the network.

Founding Members of the IBTN

Name Institution Position
Simon Bacon, PhD Concordia University and Hôpital du Sacré-Coeur de Montréal Professor of Exercise Science and Co-Director of the Montreal Behavioural Medicine Centre
Kim Lavoie, PhD Université du Québec à Montréal and Hôpital du Sacré-Coeur de Montréal Professor of Psychology and Co-Director of the Montreal Behavioural Medicine Centre
Gregory Ninot, PhD University of Montpellier Director of the Epsylon Laboratory
Jean Bourbeau, MD Montreal Chest Institute and McGill University Director of the Respiratory Epidemiology and Clinical Research Unit (RECRU)
Isabelle Boutron, MD University Paris Descartes and INSERM U738 Professor of Clinical Epidemiology
Tim Caulfield, PhD University of Alberta Canada Research Chair in Health Law and Policy
Susan Czajkowski, PhD National Heart, Lung and Blood Institute, NIH Program Director
Karina Davidson, PhD Columbia University Director of the Center for Behavioral and Cardiovascular Health
Kenneth Freedland, PhD Washington University School of Medicine Professor of Psychiatry and Psychology
Gaston Godin, PhD Laval University Professor Emeritus
Susan Michie, PhD University College London Director of the Health Psychology Research Group
David Moher, PhD Ottawa Hospital Research Institute University of Ottawa Research Chair
Paul Montgomery, DPhil Oxford University Professor of Psycho-Social Intervention
Lynda Powell, PhD Rush University Medical Center Charles J. and Margaret Roberts Professor of Preventive Medicine
Lise Rochaix, PhD Université Paris 1 Panthéon-Sorbonne Professeur des Universités en Sciences économiques
David Secko, PhD Concordia University Team Leader of the Concordia Science Journalism Project
Stan Shapiro, PhD McGill University Professor of Epidemiology and Biostatistics
Bonnie Spring, PhD Northwestern University Director of the Center for Behavior and Health

Compliance with Ethics Guidelines

Conflict of Interest

Kenneth Freedland, Kim Lavoie, Susan Czajkowski, Susan Michie, Lynda H. Powell, Gregory Ninot, and Bonnie Spring have no conflicts of interest. Simon Bacon received a grant from the Canadian Institutes of Health Research (CIHR) and the Fonds de Recherche du Quebec—Sante. Paul Montgomery received support from CIHR.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.

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Correspondence to Simon L. Bacon.

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This article is part of the Topical Collection on Physical Activity

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Bacon, S.L., Lavoie, K.L., Ninot, G. et al. An International Perspective on Improving the Quality and Potential of Behavioral Clinical Trials. Curr Cardiovasc Risk Rep 9, 427 (2015). https://doi.org/10.1007/s12170-014-0427-0

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Keywords

  • Behavioral trials
  • Clinical trials
  • Control groups
  • Methodology
  • Outcomes
  • Treatment fidelity
  • International Behavioural Trials Network