The WORLD (Weight Optimization: Revamping Lifestyles Using the Dietary Guidelines) Study - Developing, Implementing, and Testing an Education Program
Completed · Not applicable
Conditions studied: Obesity, Cardiovascular Disease
In brief
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.
Key facts
- Study ID
- NCT00847574
- Run by
- Penn State University
- People needed
- 101
- Starts
- 2006-03-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2023-08-18
Who can join
Age: 21 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 21-50 years
- BMI: 25-39.9 kg/m2
- LDL-C: 100-189.9 mg/dL
You may not qualify if…
- 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
- Physical Activity Readiness Questionnaire score > 2
Where it is running
- Penn State University — University Park, Pennsylvania, United States
Full record on ClinicalTrials.gov
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