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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00847574
First Posted: February 19, 2009
Last Update Posted: December 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
United States Department of Agriculture (USDA)
Information provided by (Responsible Party):
Penny Kris-Etherton, Penn State University
  Purpose
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.

Condition Intervention
Obesity Cardiovascular Disease Behavioral: Moderate-fat Behavioral: Lower-fat

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Development, Implementation, & Testing and Education Program to Teach Weight Loss Using the 2005 Dietary Guidelines to Pre-Menopausal Women

Resource links provided by NLM:


Further study details as provided by Penny Kris-Etherton, Penn State University:

Primary Outcome Measures:
  • Body weight [ Time Frame: Baseline, month 4, month 8, month 12 ]

Secondary Outcome Measures:
  • Lipid Profile [ Time Frame: Baseline, month 4, month 8, month 12 ]
  • Glucose [ Time Frame: Baseline, month 4, month 8, month 12 ]
  • Insulin [ Time Frame: Baseline, month 4, month 8, month 12 ]
  • C-reactive protein [ Time Frame: Baseline, month 4, month 8, month 12 ]
  • Dietary intake [ Time Frame: Baseline, month 4, month 12 ]
  • Body composition [ Time Frame: Baseline, month 4, month 12 ]
  • Fitness via VO2max [ Time Frame: Baseline, month 4, month 12 ]
  • Cognitive-behavioral measures [ Time Frame: Baseline, month 4, month 8, month 12 ]

Enrollment: 101
Study Start Date: March 2006
Study Completion Date: December 2010
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moderate-fat
35% of calories from fat
Behavioral: Moderate-fat
35% of calories from fat
Experimental: Lower-fat
20% of calories from fat
Behavioral: Lower-fat
20% of calories from fat

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00847574


Locations
United States, Pennsylvania
Penn State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
United States Department of Agriculture (USDA)
Investigators
Principal Investigator: Penny M Kris-Etherton, PhD, RD Penn State University
  More Information

Additional Information:
Responsible Party: Penny Kris-Etherton, Distinguished Professor of Nutrition, Penn State University
ClinicalTrials.gov Identifier: NCT00847574     History of Changes
Other Study ID Numbers: WORLD Study
USDA CSREES #2005-55215-04811
First Submitted: February 18, 2009
First Posted: February 19, 2009
Last Update Posted: December 1, 2011
Last Verified: November 2011

Keywords provided by Penny Kris-Etherton, Penn State University:
Weight loss
Weight maintenance
Weight management
Cardiovascular disease risk
Dietary Guidelines
Diet and exercise
Prevention

Additional relevant MeSH terms:
Cardiovascular Diseases