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

Chinese PLA General Hospital2 sites in 1 country1,000 target enrollmentDecember 2015

ConditionsObesity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obesity
Sponsor: Chinese PLA General Hospital
Enrollment: 1000
Locations: 2
Primary Endpoint: Composite changes of weight, waist circumference and BMI
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2015

End Date

December 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chinese PLA General Hospital

Responsible Party

Principal Investigator

Qiang Zeng

Director of Health Management Institue

Chinese PLA General Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Composite changes of weight, waist circumference and BMI

Time Frame: 3~5 years

the measure is a composite

Dropout ratio during weight-loss period and maintenance period

Time Frame: 3~5 years

Body composition change is measured by means of Bioelectrical Impedance Analysis (BIA) and CT scan

Time Frame: 3~5 years

Secondary Outcomes

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)