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14 Interventions to Promote Health and Prevent Disease: Perspectives on Clinical Trials Past, Present, and Future--S. Leonard Syme and Abby C. King
Pages 284-300

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From page 284...
... King As a 2000 report by the Institute of Medicine (IOM) observed, health interventions based on social and behavioral research have great potential to improve health and prevent disease.
From page 285...
... These recommendations included carrying out studies aimed at identifying the pathways through which social contexts affect disease pathogenesis and outcomes and performing cost-effectiveness analyses that could identify those interventions with the greatest potential to improve health at the least expense. The general tenor of the report was very positive, because it emphasized the potential of intervention trials based on behavioral and social research and called for continuing work in the area.
From page 286...
... Challenges to Randomized Controlled Trials We begin by describing the difficulties associated with one of the most expensive and ambitious randomized and controlled clinical trials ever conducted: the Multiple Risk Factor Intervention Trial, or MRFIT (Multiple Risk Factor Intervention Trial Research Group, 1982)
From page 287...
... In that trial, lifestyle intervention aimed primarily at weight loss and increases in regular physical activity in a large study sample at high risk for diabetes led to a 58 percent lower diabetes incidence in this group relative to controls and a 39 percent lower diabetes incidence in the lifestyle group relative to the group taking metformin (Knowler et al., 2002)
From page 288...
... Notably, however, the effects of an intervention can extend beyond what the investigators originally conceptualized or intended. In the Multiple Risk Factor Intervention Trial, the focus was on blood pressure, fat in the diet, and cigarette smoking.
From page 289...
... By the time drivers were 60 years old, the prevalence of hypertension among them was 90 percent. A research grant from the National Heart, Lung, and Blood Institute allowed us to conduct an epidemiologic study of hypertension risk factors that led to the development of an intervention project to reduce the rate of hypertension among the drivers.
From page 290...
... One of these trials was the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) trial (Berkman et al., 2003)
From page 291...
... What has been Learned Since the 2000 IOM Report Since the publication of the 2000 IOM report, basic understanding of interventions to change health behaviors has greatly improved. This growing knowledge, along with advances in intervention methods and design and an increasing understanding of the importance of contextual and environmental factors in influencing daily health decisions, has opened the way to more potent and sustainable interventions.
From page 292...
... (2004) found that while intervening in depression and low perceived social support within 28 days after myocardial infarction did not increase event-free survival rate, it seemed that white men -- although not other subgroups -- may have benefited from the ENRICHD intervention.
From page 293...
... . Other innovative methods for enhancing the flexibility and real-world relevance of clinical trials research include adaptive designs that use a stepped-care approach to intervention delivery based on participant response and adaptive interventions that use prespecified decision rules based on tailoring variables to adjust intervention dose and related parameters (Collins et al., 2005)
From page 294...
... Importance of Aiming for the Underlying Drivers of Health One key fact about intervention trials is that they rarely attempt to intervene in the fundamental driving forces in society -- both social and environmental -- that are responsible for many of the health problems in the first place. These upstream social and environmental factors that influence health and disease include such factors as poverty, lack of education, and neighborhood incivilities that can negatively affect daily health-related decisions and behaviors regardless of how committed an individual or community may be to living a healthier life.
From page 295...
... Better Defining the Needs of Different Population Groups Through Community-Based Participatory Research Methods In recent years, there has been an increasing appreciation among public health researchers of the critical perspectives that community members can bring to the intervention research endeavor (Minkler and Wallerstein, 2008)
From page 296...
... For example, eHealth advances provide previously unimagined opportunities to positively affect daily health behaviors and choices that can broadly influence the health of the population (King and Guralnik, 2010)
From page 297...
... Researchers carrying out such intervention trials in the future should keep in mind the importance of aiming for the underlying drivers of health, of using community-based participatory research methods, of applying new digital communications technologies, and of including the public in data-gathering efforts. Researchers should also consider using a two-step model framework that interprets psychosocial risk factors as increasing a general susceptibility to poor health and disease.
From page 298...
... . Exploring refinements in targeted behavioral medicine intervention to advance public health.
From page 299...
... , 275-284. Multiple Risk Factor Intervention Trial Research Group.


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