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10 Interventions to Promote Health and Prevent Disease: Perspectives on Clinical Trials Past, Present, and Future
Pages 179-191

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From page 179...
... It suggested, for example, that interventions should be carried out to address the health of potential mothers before they get pregnant and that efforts should be made to increase the social capital of communities and neighborhoods in order to improve the effectiveness of behavioral change interventions. The report also made a number of research recommendations for studies that could support and strengthen intervention trials.
From page 180...
... In this section we discuss some of the most commonly encountered ones. 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 181...
... 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 182...
... While scientists may focus on a defined range of "risk factors" being targeted by an intervention, study participants often focus on broader "life factors." General Challenges to Intervention Trials In addition to the challenges specific to randomized controlled trials, there are a variety of challenges that face intervention trials in general, including both RCTs and other types of trials. Choice of Outcomes Many failures to successfully intervene may be due to the fact that the intervention is aimed at the wrong outcomes.
From page 183...
... 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 184...
... Both of the trials were well designed and carefully implemented, but neither showed significant results relative to controls. One of these trials was the Enhancing Recovery for Coronary Heart Disease Patients (ENRICHD)
From page 185...
... 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 186...
... . 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 187...
... For example, people in lower social class positions have higher rates of not just one or two diseases, but of virtually every disease studied. The same phenomenon exists for social support: In many studies people with poor social connections have higher mortality rates than people with better social connections, and these observations hold after controlling for age, gender, and health status.
From page 188...
... Interleukin-6 plays an important role in the immune functioning of the body and is related to a number of diseases, including diabetes, coronary heart disease, rheumatoid arthritis, depression, and prostate cancer. These and related results can further the understanding of such two-step models of disease etiology.
From page 189...
... 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 190...
... . Effects of treating depression and low perceived social support on clinical events after myocardial infarction: The enhancing recovery in coronary heart disease patients (ENRICHD)
From page 191...
... , 275-284. Multiple Risk Factor Intervention Trial Research Group.


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