Development, Implementation, & Testing and Education Program to Teach Weight Loss Using the 2005 Dietary Guidelines to Pre-Menopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •21-50 years
- •BMI: 25-39.9 kg/m2
- •LDL-C: 100-189.9 mg/dL
排除标准
- •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
研究组 & 干预措施
Moderate-fat
35% of calories from fat
干预措施: Moderate-fat (Behavioral)
Lower-fat
20% of calories from fat
干预措施: Lower-fat (Behavioral)
结局指标
主要结局
Body weight
时间窗: Baseline, month 4, month 8, month 12
次要结局
- Dietary intake(Baseline, month 4, month 12)
- Glucose(Baseline, month 4, month 8, month 12)
- Fitness via VO2max(Baseline, month 4, month 12)
- Insulin(Baseline, month 4, month 8, month 12)
- Lipid Profile(Baseline, month 4, month 8, month 12)
- Body composition(Baseline, month 4, month 12)
- C-reactive protein(Baseline, month 4, month 8, month 12)
- Cognitive-behavioral measures(Baseline, month 4, month 8, month 12)
