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

Last updated: August 15, 2023
Sponsor: Penn State University
Overall Status: Completed

Phase

N/A

Condition

Obesity

Diabetes Prevention

Heart Disease

Treatment

Moderate-fat

Lower-fat

Clinical Study ID

NCT00847574
WORLD Study
USDA CSREES #2005-55215-04811
  • Ages 21-50
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 21-50 years
  • BMI: 25-39.9 kg/m2
  • LDL-C: 100-189.9 mg/dL

Exclusion

Exclusion Criteria:

  • Triglycerides > 350 mg/dL
  • History of myocardial infarction, stroke, diabetes mellitus, liver disease, kidneydisease, 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

Study Design

Total Participants: 101
Treatment Group(s): 2
Primary Treatment: Moderate-fat
Phase:
Study Start date:
March 01, 2006
Estimated Completion Date:
December 31, 2010

Connect with a study center

  • Penn State University

    University Park, Pennsylvania 16802
    United States

    Site Not Available

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