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

August 15, 2023 updated by: Penn State University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • Penn State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body weight
Time Frame: Baseline, month 4, month 8, month 12
Baseline, month 4, month 8, month 12

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Collaborators

United States Department of Agriculture (USDA)

Investigators

  • Principal Investigator: Penny M Kris-Etherton, PhD, RD, Penn State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

February 18, 2009

First Submitted That Met QC Criteria

February 18, 2009

First Posted (Estimated)

February 19, 2009

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WORLD Study
  • USDA CSREES #2005-55215-04811

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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