NCT00847574

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Penn State University · Academic / Other
• Sex: Female
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity
• Cardiovascular Disease

Interventions

Type	Name	Description
BEHAVIORAL	Moderate-fat	35% of calories from fat
BEHAVIORAL	Lower-fat	20% of calories from fat

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-06-01
• Completion: 2010-12-01
• First posted: 2009-02-19
• Last updated: 2023-08-18

Locations

1 site across 1 country: United States