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Completed

NCT Number: NCT00847574

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

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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Key information

Conditions

Obesity Behavior Body Weight Body Weight Changes Cardiovascular Disease Cardiovascular Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

21 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Penn State University

University Park, Pennsylvania, 16802, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moderate-fat

Behavioral

35% of calories from fat

Lower-fat

Behavioral

20% of calories from fat

Primary outcomes

  1. Body weight

    Time frame: Baseline, month 4, month 8, month 12

Secondary outcomes

  1. Lipid Profile

    Time frame: Baseline, month 4, month 8, month 12

  2. Glucose

    Time frame: Baseline, month 4, month 8, month 12

  3. Insulin

    Time frame: Baseline, month 4, month 8, month 12

  4. C-reactive protein

    Time frame: Baseline, month 4, month 8, month 12

  5. Dietary intake

    Time frame: Baseline, month 4, month 12

  6. Body composition

    Time frame: Baseline, month 4, month 12

  7. Fitness via VO2max

    Time frame: Baseline, month 4, month 12

  8. Cognitive-behavioral measures

    Time frame: Baseline, month 4, month 8, month 12

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • United States Department of Agriculture (USDA)

Registry information

Official study title

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

Acronym: WORLD

Important dates

Study start
2006
Primary completion
2008
Study completion
2010
First posted
Feb 19, 2009
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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