Clinical trial NCT00847574: The WORLD (Weight Optimization: Revamping Lifestyles Using the Dietary Guidelines) Study - Developing, Implementing, and Testing an Education Program
Official title: Development, Implementation, & Testing and Education Program to Teach Weight Loss Using the 2005 Dietary Guidelines to Pre-Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Cardiovascular Disease
Keywords: Weight loss
Weight maintenance
Weight management
Cardiovascular disease risk
Dietary Guidelines
Diet and exercise
Prevention
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
First posted: 2009-02-19
Enrollment: 101
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Body weight
timeFrame: Baseline, month 4, month 8, month 12
Secondary outcomes:
measure: Lipid Profile
timeFrame: Baseline, month 4, month 8, month 12
measure: Glucose
timeFrame: Baseline, month 4, month 8, month 12
measure: Insulin
timeFrame: Baseline, month 4, month 8, month 12
measure: C-reactive protein
timeFrame: Baseline, month 4, month 8, month 12
measure: Dietary intake
timeFrame: Baseline, month 4, month 12
measure: Body composition
timeFrame: Baseline, month 4, month 12
measure: Fitness via VO2max
timeFrame: Baseline, month 4, month 12
measure: Cognitive-behavioral measures
timeFrame: Baseline, month 4, month 8, month 12
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Penny M Kris-Etherton, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: