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临床试验/NCT00847574
NCT00847574已完成不适用

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

Penn State University1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2006年3月1日最近更新:
适应症
干预措施

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

Experimental

35% of calories from fat

干预措施: Moderate-fat (Behavioral)

Lower-fat

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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