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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02509741
• Other study ID #: CHPF2012014
• Status: Recruiting
• Phase: N/A
• First received: July 15, 2015
• Last updated: October 31, 2017
• Start date: December 2015

Study information

• Verified date: October 2017
• Source: Chinese PLA General Hospital
• Contact: Yuan He, MD
• Phone: +86-10-62115671
• Email: heyuan8506[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Obesity

Intervention

Behavioral:
• Education

Dietary Supplement:
• Food replacement

Behavioral:
• IOT monitoring

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing	Chongqing
China	Hangzhou PLA sanatorium	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite changes of weight, waist circumference and BMI	the measure is a composite	3~5 years
Primary	Body composition change is measured by means of Bioelectrical Impedance Analysis (BIA) and CT scan		3~5 years
Primary	Dropout ratio during weight-loss period and maintenance period		3~5 years
Secondary	Composite changes in cardiovascular health indicators such as blood pressure, blood glucose, and blood lipids		3~5 years
Secondary	Composite changes in inflammatory markers, diet and physical activity level, Leptin and adiponectin, compliance of weight-loss and other indicators		3~5 years
Secondary	Composite changes in diet-related behaviors such as satiety, food preferences, social support, appetite, healthy lifestyle and psychological aspects		3~5 years