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

Chinese PLA General Hospital (301 Hospital)

Status: Unknown

Conditions: Obesity

Treatments: Behavioral: IOT monitoring; Dietary Supplement: Food replacement; Behavioral: Education

Study type: Interventional

Funder types: Other

Identifiers

NCT02509741

CHPF2012014

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 4 patient groups

Educational intervention

Experimental group

Description:

High-protein and low-GI diet education

Treatment:

Behavioral: Education

Dietary intervention

Experimental group

Description:

High-protein and low-GI diet plus education

Treatment:

Behavioral: Education

Dietary Supplement: Food replacement

Internet-of-things (IOT) monitoring intervention

Experimental group

Description:

Dietary intervention plus IOT monitoring

Treatment:

Behavioral: Education

Behavioral: IOT monitoring

Dietary Supplement: Food replacement

control

No Intervention group

Description:

Routine diet recommendation