The WORLD (Weight Optimization: Revamping Lifestyles Using the Dietary Guidelines) Study - Developing, Implementing, and Testing an Education Program (WORLD)
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The WORLD study is a single-center, year-long randomized controlled trial in free-living women. Participants were randomly assigned to follow either a lower-fat (LF) diet or a moderate-fat (MF) diet for weight management in a parallel-arm design. The two phases of the study were a weight-loss phase (phase 1) and a weight-maintenance phase (phase 2) (Figure 1). During phase 1, months 1 through 4, participants consumed a hypo-caloric diet consistent with the 2005 Dietary Guidelines in the free-living environment. During phase 2, months 5 through 12, participants shifted into weight maintenance. It was hypothesized that a weight-loss intervention at the extremes of dietary fat recommendations of the 2005 Dietary Guidelines would be equally effective for weight loss while achieving comparable nutrient adequacy. Also, Overall, the lower-fat and moderate-fat diets would both be nutritionally adequate, based on the Healthy Eating Index.
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Ages Eligible for Study:
21 Years to 50 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
BMI: 25-39.9 kg/m2
LDL-C: 100-189.9 mg/dL
Triglycerides > 350 mg/dL
History of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease
High alcohol consumption (<14 drinks/week)
Use of medication or supplements for lowering blood lipid levels (i.e., statin, fibrates, psyllium, fish oil capsules, soy lecithin, phytoestrogens)
Lactating, pregnant, or wanting to become pregnant during the study
Weight loss or gain ≥ 10% body weight in the previous 6 months
Eating Attitudes Test-26 score > 20
Beck Depression Inventory-II score ≥ 29
Gormally Cognitive Factors Related to Binge Eating Scale score > 30