Design and methods for testing a simple dietary message to improve weight loss and dietary quality.
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
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.


CONCLUSIONS
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.


BACKGROUND
NCT00911885.
Merriam
Philip A
PA
Division of Preventive and Behavioral Medicine, Department of Medicine, University of Massachusetts Medical School, Worcester, MA, USA. Philip.Merriam@umassmed.edu
Ma
Yunsheng
Y
Olendzki
Barbara C
BC
Schneider
Kristin L
KL
Li
Wenjun
W
Ockene
Ira S
IS
Pagoto
Sherry L
SL
D000328:Adult; D004043:Dietary Fiber / Q000008:administration & dosage*; D002149:Energy Intake / Q000502:physiology; D005260:Female; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D008297:Male; D024821:Metabolic Syndrome / Q000178:diet therapy*; D009765:Obesity / Q000178:diet therapy*; D010349:Patient Compliance; D012107:Research Design; D015431:Weight Loss