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

NCT ID: NCT02509741

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

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.

Detailed Description

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Conditions

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Obesity

Keywords

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obesity nutrition intervention food replacement IOT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Educational intervention

High-protein and low-GI diet education

Group Type EXPERIMENTAL

Education

Intervention Type BEHAVIORAL

Dietary intervention

High-protein and low-GI diet plus education

Group Type EXPERIMENTAL

Education

Intervention Type BEHAVIORAL

Food replacement

Intervention Type DIETARY_SUPPLEMENT

Internet-of-things (IOT) monitoring intervention

Dietary intervention plus IOT monitoring

Group Type EXPERIMENTAL

Education

Intervention Type BEHAVIORAL

Food replacement

Intervention Type DIETARY_SUPPLEMENT

IOT monitoring

Intervention Type BEHAVIORAL

control

Routine diet recommendation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Education

Intervention Type BEHAVIORAL

Food replacement

Intervention Type DIETARY_SUPPLEMENT

IOT monitoring

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qiang Zeng

Director of Health Management Institue

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qiang Zeng, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

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Southwest Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Hangzhou PLA sanatorium

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuan He, MD

Role: CONTACT

Phone: +86-10-62115671

Email: [email protected]

Facility Contacts

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Xiaolan Zhao

Role: primary

Zili Zhong

Role: primary

Other Identifiers

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CHPF2012014

Identifier Type: -

Identifier Source: org_study_id