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Lifestyle Intervention Trial in High Metabolic Risk Chinese

NCT04714723 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 395

Last updated 2024-02-09

No results posted yet for this study

Summary

In this single-blind, randomized trial, 395 eligible volunteers, who have higher metabolic syndrome (MetS) risk and aged 20-65 years, will be assigned to one of two smartphone-based lifestyle intervention arms: 1) Programmed-smartphone intervention or 2) Programmed-smartphone plus dietitian intervention. Before and after 6-month intervention, "PhenFlex test" (PFT) was performed to examine and quantify improved metabolic flexibility.

This intervention trial will be conducted by researchers in Shanghai Institute of Nutrition and Health of the Chinese Academy of Sciences (CAS) collaborating with Zhejiang University affiliated Sir Run Run Shaw Hospital. The study protocol was approved by the Ethics Committees in Shanghai Institutes of Nutrition and Health, and in Sir Run Run Shaw Hospital.

The main aims of this study are to determine 1) efficacy of lifestyle interventions with different intensity in reducing MetS and its risk factors; 2) improved metabolic responses or flexibility defined by PFT-based homeostasis index; and 3) major genetic and nongenetic determinants for the efficacy of interventions among high MetS risk Chinese.

Conditions

Interventions

BEHAVIORAL

Programmed smartphone intervention

Interactive programmed lifestyle education based on smartphone for six month

BEHAVIORAL

Programmed smartphone plus dietitian intervention

Interactive programmed lifestyle education based on smartphone plus dietitians support for six month

Sponsors & Collaborators

  • Sir Run Run Shaw Hospital

    collaborator OTHER

  • Chinese Academy of Sciences

    lead OTHER_GOV

Principal Investigators

  • Xu Lin, PhD · Shanghai Institute of Nutrition and Health, Chinese Acadamy of Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-27
Primary Completion
2021-11-30
Completion
2023-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04714723 on ClinicalTrials.gov