Status:
COMPLETED
The WORLD (Weight Optimization: Revamping Lifestyles Using the Dietary Guidelines) Study - Developing, Implementing, and Testing an Education Program
Lead Sponsor:
Penn State University
Collaborating Sponsors:
United States Department of Agriculture (USDA)
Conditions:
Obesity
Cardiovascular Disease
Eligibility:
FEMALE
21-50 years
Phase:
NA
Brief Summary
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 f...
Eligibility Criteria
Inclusion
- 21-50 years
- BMI: 25-39.9 kg/m2
- LDL-C: 100-189.9 mg/dL
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00847574
Start Date
March 1 2006
End Date
December 1 2010
Last Update
August 18 2023
Active Locations (1)
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1
Penn State University
University Park, Pennsylvania, United States, 16802