The WORLD (Weight Optimization: Revamping Lifestyles Using the Dietary Guidelines) Study - Developing, Implementing, and Testing an Education Program

Obesity Clinical Trial

— WORLD  

Official title:

Development, Implementation, & Testing and Education Program to Teach Weight Loss Using the 2005 Dietary Guidelines to Pre-Menopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847574
• Other study ID #: WORLD Study
• Secondary ID: USDA CSREES #200
• Status: Completed
• Phase: N/A
• Start date: March 2006
• Est. completion date: December 2010

Study information

• Verified date: August 2023
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 2010
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

• 21-50 years

• BMI: 25-39.9 kg/m2

• LDL-C: 100-189.9 mg/dL

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Obesity

Intervention

Behavioral:
• Moderate-fat
35% of calories from fat
• Lower-fat
20% of calories from fat

Locations

Country	Name	City	State
United States	Penn State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight		Baseline, month 4, month 8, month 12
Secondary	Lipid Profile		Baseline, month 4, month 8, month 12
Secondary	Glucose		Baseline, month 4, month 8, month 12
Secondary	Insulin		Baseline, month 4, month 8, month 12
Secondary	C-reactive protein		Baseline, month 4, month 8, month 12
Secondary	Dietary intake		Baseline, month 4, month 12
Secondary	Body composition		Baseline, month 4, month 12
Secondary	Fitness via VO2max		Baseline, month 4, month 12
Secondary	Cognitive-behavioral measures		Baseline, month 4, month 8, month 12

External Links

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