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

Not Applicable

• Conditions: Obesity
• Interventions: Behavioral: Education; Dietary Supplement: Food replacement; Behavioral: IOT monitoring

• Registration Number: NCT02509741
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-27
• Study First Posted: 2015-07-28
• Study Start: 2015-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-01
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet-of-things (IOT) monitoring intervention	Food replacement	Dietary intervention plus IOT monitoring
Educational intervention	Education	High-protein and low-GI diet education
Dietary intervention	Food replacement	High-protein and low-GI diet plus education
Internet-of-things (IOT) monitoring intervention	Education	Dietary intervention plus IOT monitoring
Internet-of-things (IOT) monitoring intervention	IOT monitoring	Dietary intervention plus IOT monitoring
Dietary intervention	Education	High-protein and low-GI diet plus education

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China

Hangzhou PLA sanatorium; 🇨🇳 Hangzhou, Zhejiang, China