Effect of Nutrition and Lifestyles on Obesity and Chronic Disease in China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Composite changes of weight, waist circumference and BMI
研究概览
简要总结
This research is aimed at verifying the effects of diets with high protein and low glycemic index (GI) on weight management among overweight or obese Chinese adult. Additionally, the investigators intend to verify the effects of two new approaches, including food replacement and Internet-of-things (IOT) monitoring on weight control.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Health adult, age:18-65，BMI（kg/m2）:27.0-40.0
排除标准
- •Patients under regular medical treatment for chronic diseases like diabetes, hypertension, gout and hyperuricemia.
- •The patients with chronic renal diseases or other diseases which impose restrictions on the intake of proteins.
- •Mental patients.
- •People who suffer from secondary obesity caused by endocrine, metabolic disorders or some central nervous system diseases.
- •People who are under medical or surgical weight-loss treatments in the past three months.
- •People whose weight fluctuations are not less than 5kg in the past two months；
- •People with food allergies.
- •Men or women who drink regularly over 25g or 15 g daily,respectively.
- •Pregnant women and women who prepare to be pregnant.
- •Lactating women
研究组 & 干预措施
Educational intervention
High-protein and low-GI diet education
干预措施: Education (Behavioral)
Dietary intervention
High-protein and low-GI diet plus education
干预措施: Education (Behavioral)
Dietary intervention
High-protein and low-GI diet plus education
干预措施: Food replacement (Dietary Supplement)
Internet-of-things (IOT) monitoring intervention
Dietary intervention plus IOT monitoring
干预措施: Education (Behavioral)
Internet-of-things (IOT) monitoring intervention
Dietary intervention plus IOT monitoring
干预措施: Food replacement (Dietary Supplement)
Internet-of-things (IOT) monitoring intervention
Dietary intervention plus IOT monitoring
干预措施: IOT monitoring (Behavioral)
control
Routine diet recommendation
结局指标
主要结局
Composite changes of weight, waist circumference and BMI
时间窗: 3~5 years
the measure is a composite
Dropout ratio during weight-loss period and maintenance period
时间窗: 3~5 years
Body composition change is measured by means of Bioelectrical Impedance Analysis (BIA) and CT scan
时间窗: 3~5 years
次要结局
- Composite changes in inflammatory markers, diet and physical activity level, Leptin and adiponectin, compliance of weight-loss and other indicators(3~5 years)
- Composite changes in cardiovascular health indicators such as blood pressure, blood glucose, and blood lipids(3~5 years)
- Composite changes in diet-related behaviors such as satiety, food preferences, social support, appetite, healthy lifestyle and psychological aspects(3~5 years)
研究者
Qiang Zeng
Director of Health Management Institue
Chinese PLA General Hospital