Back to resultsEffect of Nutrition and Lifestyles on Obesity and Chronic Disease in China
Primary Purpose
Obesity
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Education
Food replacement
IOT monitoring
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring obesity, nutrition, intervention, food replacement, IOT
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
Sites / Locations
- Southwest HospitalRecruiting
- Hangzhou PLA sanatoriumRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Educational intervention
Dietary intervention
Internet-of-things (IOT) monitoring intervention
control
Arm Description
High-protein and low-GI diet education
High-protein and low-GI diet plus education
Dietary intervention plus IOT monitoring
Routine diet recommendation
Outcomes
Primary Outcome Measures
Composite changes of weight, waist circumference and BMI
the measure is a composite
Body composition change is measured by means of Bioelectrical Impedance Analysis (BIA) and CT scan
Dropout ratio during weight-loss period and maintenance period
Secondary Outcome Measures
Composite changes in cardiovascular health indicators such as blood pressure, blood glucose, and blood lipids
Composite changes in inflammatory markers, diet and physical activity level, Leptin and adiponectin, compliance of weight-loss and other indicators
Composite changes in diet-related behaviors such as satiety, food preferences, social support, appetite, healthy lifestyle and psychological aspects
Full Information
NCT ID
NCT02509741
First Posted
July 15, 2015
Last Updated
October 31, 2017
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02509741
Brief Title
Effect of Nutrition and Lifestyles on Obesity and Chronic Disease in China
Official Title
Effect of Nutrition and Lifestyles on Obesity and Chronic Disease in China
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, nutrition, intervention, food replacement, IOT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Educational intervention
Arm Type
Experimental
Arm Description
High-protein and low-GI diet education
Arm Title
Dietary intervention
Arm Type
Experimental
Arm Description
High-protein and low-GI diet plus education
Arm Title
Internet-of-things (IOT) monitoring intervention
Arm Type
Experimental
Arm Description
Dietary intervention plus IOT monitoring
Arm Title
control
Arm Type
No Intervention
Arm Description
Routine diet recommendation
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Type
Dietary Supplement
Intervention Name(s)
Food replacement
Intervention Type
Behavioral
Intervention Name(s)
IOT monitoring
Primary Outcome Measure Information:
Title
Composite changes of weight, waist circumference and BMI
Description
the measure is a composite
Time Frame
3~5 years
Title
Body composition change is measured by means of Bioelectrical Impedance Analysis (BIA) and CT scan
Time Frame
3~5 years
Title
Dropout ratio during weight-loss period and maintenance period
Time Frame
3~5 years
Secondary Outcome Measure Information:
Title
Composite changes in cardiovascular health indicators such as blood pressure, blood glucose, and blood lipids
Time Frame
3~5 years
Title
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
Title
Composite changes in diet-related behaviors such as satiety, food preferences, social support, appetite, healthy lifestyle and psychological aspects
Time Frame
3~5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan He, MD
Phone
+86-10-62115671
Email
heyuan8506@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiang Zeng, MD
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaolan Zhao
Phone
+86-23-68754919
Email
zhaoxiaolan65@126.com
Facility Name
Hangzhou PLA sanatorium
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zili Zhong
Phone
+86-0571-87127082
Email
zhongzili@nutriease.com
12. IPD Sharing Statement
Learn more about this trial
Effect of Nutrition and Lifestyles on Obesity and Chronic Disease in China
We'll reach out to this number within 24 hrs