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NCT04714723

Lifestyle Intervention Trial in High Metabolic Risk Chinese

Completed NA Last updated 9 February 2024
What this trial tests

NA trial testing Programmed smartphone intervention in Metabolic Syndrome in 395 participants. Completed in 31 December 2023.

Timeline
27 December 2020
Primary endpoint
30 November 2021
31 December 2023

Quick facts

Lead sponsorChinese Academy of Sciences
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment395
Start date27 December 2020
Primary completion30 November 2021
Estimated completion31 December 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Chinese Academy of Sciences — full company profile →

Who can join

Adults 20 to 65, any sex, with Metabolic Syndrome or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Impacts of Behavioral Compliance on Weight-Loss and Metabolic Profile in a Smartphone App-Based Lifestyle Intervention or Plus Dietitian Supporting: A Randomized and Controlled Trial Among Chinese.
    Li X, Lu L, Sun L, Xie Y, et al · · 2025 · cited 1× · PMID 40606567 · DOI 10.1007/s43657-024-00162-0

Verify or expand the search:

Other recruiting trials for Metabolic Syndrome

Currently open trials in the same condition.

Other Chinese Academy of Sciences trials

Trials by the same sponsor.

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Data sources for this page

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