NCT00847574

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

2.3 years

First QC Date

February 18, 2009

Last Update Submit

August 15, 2023

Conditions

ObesityCardiovascular Disease

Keywords

Weight lossWeight maintenanceWeight managementCardiovascular disease riskDietary GuidelinesDiet and exercisePrevention

Outcome Measures

Primary Outcomes (1)

  • Body weight

    Baseline, month 4, month 8, month 12

Secondary Outcomes (8)

  • Lipid Profile

    Baseline, month 4, month 8, month 12

  • Glucose

    Baseline, month 4, month 8, month 12

  • Insulin

    Baseline, month 4, month 8, month 12

  • C-reactive protein

    Baseline, month 4, month 8, month 12

  • Dietary intake

    Baseline, month 4, month 12

  • +3 more secondary outcomes

Study Arms (2)

Moderate-fat

EXPERIMENTAL

35% of calories from fat

Behavioral: Moderate-fat

Lower-fat

EXPERIMENTAL

20% of calories from fat

Behavioral: Lower-fat

Interventions

Moderate-fatBEHAVIORAL

35% of calories from fat

Moderate-fat
Lower-fatBEHAVIORAL

20% of calories from fat

Lower-fat

Eligibility Criteria

Age21 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • BMI: 25-39.9 kg/m2
  • LDL-C: 100-189.9 mg/dL

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

Related Links

MeSH Terms

Conditions

ObesityCardiovascular DiseasesWeight LossMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior

Study Officials

  • Penny M Kris-Etherton, PhD, RD

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2009

First Posted

February 19, 2009

Study Start

March 1, 2006

Primary Completion

June 1, 2008

Study Completion

December 1, 2010

Last Updated

August 18, 2023

Record last verified: 2023-08

Locations

US(1)