NCT02509741

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 28, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

July 15, 2015

Last Update Submit

October 31, 2017

Conditions

Obesity

Keywords

obesitynutritioninterventionfood replacementIOT

Outcome Measures

Primary Outcomes (3)

  • Composite changes of weight, waist circumference and BMI

    the measure is a composite

    3~5 years

  • Body composition change is measured by means of Bioelectrical Impedance Analysis (BIA) and CT scan

    3~5 years

  • Dropout ratio during weight-loss period and maintenance period

    3~5 years

Secondary Outcomes (3)

  • Composite changes in cardiovascular health indicators such as blood pressure, blood glucose, and blood lipids

    3~5 years

  • Composite changes in inflammatory markers, diet and physical activity level, Leptin and adiponectin, compliance of weight-loss and other indicators

    3~5 years

  • Composite changes in diet-related behaviors such as satiety, food preferences, social support, appetite, healthy lifestyle and psychological aspects

    3~5 years

Study Arms (4)

Educational intervention

EXPERIMENTAL

High-protein and low-GI diet education

Behavioral: Education

Dietary intervention

EXPERIMENTAL

High-protein and low-GI diet plus education

Behavioral: EducationDietary Supplement: Food replacement

Internet-of-things (IOT) monitoring intervention

EXPERIMENTAL

Dietary intervention plus IOT monitoring

Behavioral: EducationDietary Supplement: Food replacementBehavioral: IOT monitoring

control

NO INTERVENTION

Routine diet recommendation

Interventions

EducationBEHAVIORAL
Dietary interventionEducational interventionInternet-of-things (IOT) monitoring intervention
Food replacementDIETARY_SUPPLEMENT
Dietary interventionInternet-of-things (IOT) monitoring intervention
IOT monitoringBEHAVIORAL
Internet-of-things (IOT) monitoring intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Health adult, age:18-65，BMI（kg/m2）:27.0-40.0

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Southwest Hospital

Chongqing, Chongqing Municipality, 410013, China

RECRUITING

Hangzhou PLA sanatorium

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Qiang Zeng, MD

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan He, MD

CONTACT

+86-10-62115671heyuan8506@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Health Management Institue

Study Record Dates

First Submitted

July 15, 2015

First Posted

July 28, 2015

Study Start

December 1, 2015

Primary Completion

December 1, 2017

Last Updated

November 1, 2017

Record last verified: 2017-10

Locations

CN(2)