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      Perspective: Randomized Controlled Trials Are Not a Panacea for Diet-Related Research 1 2

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          Abstract

          Research into the role of diet in health faces a number of methodologic challenges in the choice of study design, measurement methods, and analytic options. Heavier reliance on randomized controlled trial (RCT) designs is suggested as a way to solve these challenges. We present and discuss 7 inherent and practical considerations with special relevance to RCTs designed to study diet: 1) the need for narrow focus; 2) the choice of subjects and exposures; 3) blinding of the intervention; 4) perceived asymmetry of treatment in relation to need; 5) temporal relations between dietary exposures and putative outcomes; 6) strict adherence to the intervention protocol, despite potential clinical counter-indications; and 7) the need to maintain methodologic rigor, including measuring diet carefully and frequently. Alternatives, including observational studies and adaptive intervention designs, are presented and discussed. Given high noise-to-signal ratios interjected by using inaccurate assessment methods in studies with weak or inappropriate study designs (including RCTs), it is conceivable and indeed likely that effects of diet are underestimated. No matter which designs are used, studies will require continued improvement in the assessment of dietary intake. As technology continues to improve, there is potential for enhanced accuracy and reduced user burden of dietary assessments that are applicable to a wide variety of study designs, including RCTs.

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          Author and article information

          Journal
          Adv Nutr
          Adv Nutr
          advances in nutrition
          advannut
          Advances in Nutrition
          American Society for Nutrition
          2161-8313
          2156-5376
          9 May 2016
          May 2016
          1 May 2017
          : 7
          : 3
          : 423-432
          Affiliations
          [3 ]Cancer Prevention and Control Program, Departments of
          [4 ]Epidemiology and Biostatistics, and
          [5 ]Health Promotion, Education and Behavior, Arnold School of Public Health,
          [6 ]College of Nursing, University of South Carolina, Columbia, SC;
          [7 ]Department of Health Policy and Management, Boston University School of Public Health, Boston, MA;
          [8 ]Center for Healthcare Organization and Implementation Research, Bedford Veterans Administration Medical Center, Bedford, MA; and
          [9 ]Division of Cardiovascular Medicine, Department of Medicine, University of Massachusetts Medical School, Worcester, MA
          Author notes
          [* ]To whom correspondence should be addressed. E-mail: jhebert@ 123456sc.edu .

          1Supported by National Cancer Institute, Center to Reduce Cancer Health Disparities (Community Networks Program Centers) grant 1U54 CA153461-05 (to JRH, SAA, and TGH); National Heart, Lung, and Blood Institute grant 1R01 HL122285-01 (to JRH); and National Institute of Diabetes and Digestive and Kidney Diseases grant 1R44 DK103377-01 (to JRH and GMT-M).

          [2]

          Author disclosures: JR Hébert, EA Frongillo, SA Adams, GM Turner-McGrievy, TG Hurley, DR Miller, and IS Ockene: no conflicts of interest.

          Article
          PMC4863268 PMC4863268 4863268 011023
          10.3945/an.115.011023
          4863268
          27184269
          f8244c18-d310-4dda-b54a-a714cfb2a360
          © 2016 American Society for Nutrition
          History
          Page count
          Pages: 10
          Categories
          Perspectives

          blinding,behavioral interventions,study design,epidemiologic studies,observational studies,randomized controlled trials,dietary assessment methods,informed consent

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