Enhancing Weight Loss With Meal-Replacement Therapy in Teens With Severe Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Body Mass Index (From Baseline to 1-year)
研究概览
简要总结
This study seeks to examine whether meal-replacement therapy is able to enhance weight loss among teens with severe obesity. In addition, we are also interested in examining the degree of weight loss needed to improve important cardiometabolic risk factors among adolescents.
详细描述
This study will involve 130 adolescents (ages 13-17 years old) participating in meal replacement therapy and will last one year (12 months).
Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). Shakes/meals will be provided free of charge - fruits/vegetables will be purchased by the participants. Guidance will be provided regarding the use of the meal replacement shakes at school, and participants will be encouraged to engage in family meal sessions despite eating different foods.
We will measure the changes in resting metabolic rate, traditional clinical risk markers (TG, HDL-c, LDL-c, TC, glucose, insulin), vascular function, weight-related quality of life, and physical activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •BMI ≥1.2 times the 95th percentile (based on sex and age) or BMI ≥35 kg/m2
- •13-17 years old
排除标准
- •Type 1 or 2 diabetes mellitus
- •Previous (within 6 months) or current use of meal replacements
- •Previous (within 6 months) or current use of medication(s) prescribed primarily for weight loss (refer to appendix material for comprehensive list)
- •If currently using weight altering drug(s) for non-obesity indication(s) (refer to appendix material for comprehensive list), any change in drug(s) or dose within the previous 6 months
- •Previous bariatric surgery
- •If currently using anti-hypertensive medication(s), lipid medication(s), and/or medication(s) to treat insulin resistance (refer to appendix material for comprehensive list), any change in drug(s) or dose within the previous 6 months
- •If currently using CPAP/BIPAP (for sleep apnea), change in frequency of use or settings within the previous 6 months
- •History of treatment with growth hormone
- •Neurodevelopmental disorder severe enough to impair ability to comply with study protocol
- •Clinical diagnosis of bipolar illness, schizophrenia, conduct disorder, and/or substance use/abuse
- •Females: currently pregnant or planning to become pregnant
- •Tobacco use
- •Bulimia nervosa
- •Endorsement of vomiting, laxative use, and/or diuretic use for weight control (EDE-Q)
- •Binge eating disorder
- •Neurological disorder
- •Hypothalamic obesity
- •Obesity associated with genetic disorder (monogenetic obesity)
- •Hyperthyroidism or uncontrolled hypothyroidism
- •History of cholelithiasis
结局指标
主要结局
Body Mass Index (From Baseline to 1-year)
时间窗: 52 weeks
Percent change in body mass index (BMI) from baseline to 1-year (kg/m2)
次要结局
- Total Fat Mass (kg)(52 Weeks)
- Carotid-radial Pulse Wave Velocity (m/s)(52 weeks)
- Systolic Blood Pressure(52 weeks)
- HDL(52 Weeks)
- Insulin(52 Weeks)
- Diastolic Blood Pressure(52 weeks)
- Total Glucose(52 Weeks)
- Total Cholesterol(52 Weeks)
- LDL(52 Weeks)
- Impact of Weight-related on Quality of Life(52 weeks)
- Triglyceride/HDL Cholesterol Ratio(52 weeks)