Department of Medicine, Division of Preventive and Behavioral Medicine; Department of Medicine, Division of Cardiovascular Medicine; Clinical and Population Health Research Program
Adult; Dietary Fiber; Energy Intake; Female; Health Promotion; Humans; Male; Metabolic Syndrome X; Obesity; Patient Compliance; Research Design; *Weight Loss
Behavioral Disciplines and Activities | Behavior and Behavior Mechanisms | Community Health and Preventive Medicine | Preventative Medicine
BACKGROUND: The current food pyramid guidelines have been criticized because of their complexity and the knowledge required for users to understand the recommendations. Simplification of a dietary message to focus on a single key aspect of dietary quality, e.g., fiber intake, may make the message much easier to comprehend and adhere, such that respondents can achieve greater weight loss, better dietary quality and overall metabolic health.
METHODS AND DESIGN: This is a randomized controlled clinical trial with two equal sized arms. In total, 240 obese adults who meet diagnostic criteria for the metabolic syndrome will be randomized to one of the two conditions: 1) a high fiber diet and 2) the American Heart Association (AHA) diet. In the high fiber diet condition, patients will be given instruction only on achieving daily dietary fiber intake of 30 g or more. In the AHA diet condition, patients will be instructed to make the several dietary changes recommended by the AHA 2006 guidelines. The trial examines participant weight loss and dietary quality as well as changes in components of the metabolic syndrome, inflammatory biomarkers, low-density lipoprotein cholesterol levels, insulin levels, and glycosolated hemoglobin. Potential mediators, i.e., diet adherence and perceived ease of the diet, and the intervention effect on weight change will also be examined.
DISCUSSIONS: The purpose of this paper is to outline the study design and methods for testing the simple message of increasing dietary fiber. If the simple dietary approach is found efficacious for weight loss; and, improves dietary quality, metabolic health, and adherence, it might then be used to develop a simple public health message.
TRIAL REGISTRATION: NCT00911885.
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Citation: BMC Med Res Methodol. 2009 Dec 30;9:87. Link to article on publisher's site