NCT00212173已完成不适用
Behavioral & Pharmacologic Therapy of Adolescent Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)0 个研究点目标入组 120 人开始时间: 2005年9月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Weight
研究概览
简要总结
Protocol #1:The goals of this study was to examine whether increased weight loss in obese adolescent is induced when the weight loss medication sibutramine is added to a family-based, behavioral weight control program.
Protocol #2: This study aims to improve the behavioral treatment of obesity during adolescence. A behavioral program using regular foods will be compared to a behavioral program using a structured meal plan (a portion-controlled approach with liquid-meal replacements [nutritional supplements]). This structured approach may be better for the promotion of weight loss compared to a diet of regular foods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) between 28-50 kg/m2
排除标准
- •Severe cardiovascular problems; arrhythmias
- •Hypertension, uncontrolled (blood pressure >140/90 mm Hg)
- •Diabetes mellitus (Fasting glucose > 126)
- •Other serious medical disorders that would complicate dieting such as: Ulcer disease, cancer, thrombophlebitis, liver or kidney disease
- •Current use of weight loss medications, amphetamines, steroids, or aspirin; medications affecting body weight
- •Mental retardation or genetic syndromes associated with obesity
- •Currently pregnant or planning a pregnancy or engaging in sexual activity without using contraceptives. All females will have a serum pregnancy test at baseline and all must agree to use contraception if they are sexually active during the study.
- •History of major depression, bipolar disorder, or psychosis
- •History of anorexia or bulimia
- •Alcoholism and other substance abuse
- •Use of anti-psychotic or anti-depressant medications in the last 6 months
- •Highly dysfunctional family system or parental psychopathology
- •Weight loss in the preceding 6 months of 5% or more and/or participation in another weight loss program
- •Cigarette smoking or recent cessation
- •If taking medication for hypertension or hypercholesterolemia condition must be stable for at least 3 months prior to enrollment in the study
- •Chronic use of decongestants
- •Intolerance of SlimFast
结局指标
主要结局
Weight
BMI
次要结局
- Lipids
- Glucose
- Insulin
- Blood Pressure
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