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

October 31, 2017 updated by: Qiang Zeng, Chinese PLA General Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 410013
        • Recruiting
        • Southwest Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Hangzhou PLA sanatorium
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Educational intervention
High-protein and low-GI diet education
Behavioral: Education
Experimental: Dietary intervention
High-protein and low-GI diet plus education
Behavioral: Education
Dietary supplement: Food replacement
Experimental: Internet-of-things (IOT) monitoring intervention
Dietary intervention plus IOT monitoring
Behavioral: Education
Dietary supplement: Food replacement
Behavioral: IOT monitoring
No Intervention: control
Routine diet recommendation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Composite changes in cardiovascular health indicators such as blood pressure, blood glucose, and blood lipids
Time Frame: 3~5 years
3~5 years
Composite changes in inflammatory markers, diet and physical activity level, Leptin and adiponectin, compliance of weight-loss and other indicators
Time Frame: 3~5 years
3~5 years
Composite changes in diet-related behaviors such as satiety, food preferences, social support, appetite, healthy lifestyle and psychological aspects
Time Frame: 3~5 years
3~5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Principal Investigator: Qiang Zeng, MD, Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

July 15, 2015

First Submitted That Met QC Criteria

July 27, 2015

First Posted (Estimate)

July 28, 2015

Study Record Updates

Last Update Posted (Actual)

November 1, 2017

Last Update Submitted That Met QC Criteria

October 31, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHPF2012014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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