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

Study Overview
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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.

Official Title
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Development, Implementation, & Testing and Education Program to Teach Weight Loss Using the 2005 Dietary Guidelines to Pre-Menopausal Women

Conditions
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Obesity, Cardiovascular Disease

Intervention / Treatment
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* Behavioral: Moderate-fat
* Behavioral: Lower-fat


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate-fat<br>35% of calories from fat | Behavioral: Moderate-fat<br>* 35% of calories from fat<br>|
| Experimental: Lower-fat<br>20% of calories from fat | Behavioral: Lower-fat<br>* 20% of calories from fat<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | Baseline, month 4, month 8, month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Body composition |  | Baseline, month 4, month 12 | 
| Fitness via VO2max |  | Baseline, month 4, month 12 | 
| Cognitive-behavioral measures |  | Baseline, month 4, month 8, month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight loss, Weight maintenance, Weight management, Cardiovascular disease risk, Dietary Guidelines, Diet and exercise, Prevention