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

This study has been completed.
Sponsor:
Collaborator:
USDA Beltsville Human Nutrition Research Center
Information provided by (Responsible Party):
Penny Kris-Etherton, Penn State University
ClinicalTrials.gov Identifier:
NCT00847574
First received: February 18, 2009
Last updated: November 30, 2011
Last verified: November 2011

February 18, 2009
November 30, 2011
March 2006
June 2008   (final data collection date for primary outcome measure)
Body weight [ Time Frame: Baseline, month 4, month 8, month 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00847574 on ClinicalTrials.gov Archive Site
  • Lipid Profile [ Time Frame: Baseline, month 4, month 8, month 12 ] [ Designated as safety issue: No ]
  • Glucose [ Time Frame: Baseline, month 4, month 8, month 12 ] [ Designated as safety issue: No ]
  • Insulin [ Time Frame: Baseline, month 4, month 8, month 12 ] [ Designated as safety issue: No ]
  • C-reactive protein [ Time Frame: Baseline, month 4, month 8, month 12 ] [ Designated as safety issue: No ]
  • Dietary intake [ Time Frame: Baseline, month 4, month 12 ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: Baseline, month 4, month 12 ] [ Designated as safety issue: No ]
  • Fitness via VO2max [ Time Frame: Baseline, month 4, month 12 ] [ Designated as safety issue: No ]
  • Cognitive-behavioral measures [ Time Frame: Baseline, month 4, month 8, month 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Obesity
  • Cardiovascular Disease
  • Behavioral: Moderate-fat
    35% of calories from fat
  • Behavioral: Lower-fat
    20% of calories from fat
  • Experimental: Moderate-fat
    35% of calories from fat
    Intervention: Behavioral: Moderate-fat
  • Experimental: Lower-fat
    20% of calories from fat
    Intervention: Behavioral: Lower-fat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
December 2010
June 2008   (final data collection date for primary outcome measure)

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
Female
21 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00847574
WORLD Study, USDA CSREES #2005-55215-04811
No
Penny Kris-Etherton, Penn State University
Penn State University
USDA Beltsville Human Nutrition Research Center
Principal Investigator: Penny M Kris-Etherton, PhD, RD Penn State University
Penn State University
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP