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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Penn State University:

Primary Outcome Measures:
  • Body weight [ Time Frame: Baseline, month 4, month 8, month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   21 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847574

Locations
United States, Pennsylvania
Penn State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
USDA Beltsville Human Nutrition Research Center
Investigators
Principal Investigator: Penny M Kris-Etherton, PhD, RD Penn State University
  More Information

Additional Information:
No publications provided

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
Study First Received: February 18, 2009
Last Updated: November 30, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014