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Sponsors and Collaborators: |
Penn State University USDA CSREES #2005-55215-04811 NIH grant M01 RR 10732 |
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Information provided by: | Penn State University |
ClinicalTrials.gov Identifier: | NCT00847574 |
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 |
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Obesity Cardiovascular Disease |
Behavioral: Moderate-fat Behavioral: Lower-fat |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Development, Implementation, & Testing and Education Program to Teach Weight Loss Using the 2005 Dietary Guidelines to Pre-Menopausal Women |
Enrollment: | 101 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | December 2010 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Moderate-fat: Experimental
35% of calories from fat
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Behavioral: Moderate-fat
35% of calories from fat
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Lower-fat: Experimental
20% of calories from fat
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Behavioral: Lower-fat
20% of calories from fat
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Ages Eligible for Study: | 21 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Penn State University | |
University Park, Pennsylvania, United States, 16802 |
Principal Investigator: | Penny M Kris-Etherton, PhD, RD | Penn State University |
Responsible Party: | Penn State University ( Penny Kris-Etherton ) |
Study ID Numbers: | WORLD Study, USDA CSREES #2005-55215-04811 |
Study First Received: | February 18, 2009 |
Last Updated: | February 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00847574 History of Changes |
Health Authority: | United States: Institutional Review Board |
Weight loss Weight maintenance Weight management Cardiovascular disease risk |
Dietary Guidelines Diet and exercise Prevention |
Body Weight Signs and Symptoms Obesity Weight Loss |
Nutrition Disorders Overweight Overnutrition Menopause |
Body Weight Signs and Symptoms Obesity Nutrition Disorders |
Overweight Overnutrition Cardiovascular Diseases |