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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Moderate-fat

35% of calories from fat

Group Type EXPERIMENTAL

Moderate-fat

Intervention Type BEHAVIORAL

35% of calories from fat

Lower-fat

20% of calories from fat

Group Type EXPERIMENTAL

Lower-fat

Intervention Type BEHAVIORAL

20% of calories from fat

Interventions

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Moderate-fat

35% of calories from fat

Intervention Type BEHAVIORAL

Lower-fat

20% of calories from fat

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes