Effect of Nutrition and Lifestyles on Obesity and Chronic Disease in China

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Nutrition and Lifestyles on Obesity and Chronic Disease in China

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Education
* Dietary Supplement: Food replacement
* Behavioral: IOT monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Health adult, age:18-65，BMI（kg/m2）:27.0-40.0 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational intervention<br>High-protein and low-GI diet education | Behavioral: Education<br> <br> |
| Experimental: Dietary intervention<br>High-protein and low-GI diet plus education | Behavioral: Education<br> <br> Dietary Supplement: Food replacement<br> <br> |
| Experimental: Internet-of-things (IOT) monitoring intervention<br>Dietary intervention plus IOT monitoring | Behavioral: Education<br> <br> Dietary Supplement: Food replacement<br> <br> Behavioral: IOT monitoring<br> <br> |
| No Intervention: control<br>Routine diet recommendation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite changes of weight, waist circumference and BMI | the measure is a composite | 3 5 years | 
| Body composition change is measured by means of Bioelectrical Impedance Analysis (BIA) and CT scan |  | 3 5 years | 
| Dropout ratio during weight-loss period and maintenance period |  | 3 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite changes in cardiovascular health indicators such as blood pressure, blood glucose, and blood lipids |  | 3 5 years | 
| 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 diet-related behaviors such as satiety, food preferences, social support, appetite, healthy lifestyle and psychological aspects |  | 3 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, nutrition, intervention, food replacement, IOT