Lifestyle Intervention Trial in High Metabolic Risk Chinese
Condition: Metabolic Syndrome; Obesity
MeSH terms: Metabolic Syndrome
Study type: Interventional

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.
    

Detailed description: 
      Metabolic syndrome, a cluster of multiple metabolic disturbances, including central obesity,
      dyslipidemia, hypertension, and hyperglycemia, is associated with 2-5-fold heightened risks
      of CVD and T2D. Compelling evidence showed that lifestyle intervention is one of effective
      approaches for preventing and controlling cardiometabolic diseases. However, there were
      considerably variations among different interventions and different persons. With widely
      available smartphone and APP-connected wearable devises, it is possible to provide programmed
      nutrition and lifestyle education to help participants achieve intervention targets, and
      closely monitor compliance. However, few studies investigated the efficacy of lifestyle
      interventions with programmed smartphone and APP-connected wearable devises in MetS
      management. Moreover, since present disease-based diagnoses and biomarkers may not adequately
      define health status, the concept of "re-redefining health" has attracted growing attention.
      The phenotypic flexibility and "PhenFlex test" are one of approaches to measure individuals'
      adaptive capacity to maintain hemostatic condition after having a standardized challenge
      drinker. To date, the PFT has been studied among 10,000 subjects in western countries and few
      studies, if any, have conducted in Chinese who have different genetic background and dietary
      patterns. It remains to be established whether and to what extent that the PFT-based
      hemostatic index system can precisely evaluate the metabolic health in Chinese.

      In the current trial, 395 subjects with MetS risks were randomly assigned to either
      smartphone-based lifestyle intervention arms: 1) Programmed-smartphone intervention; or 2)
      Programmed-smartphone plus dietitian intervention. The intervention duration will be 6-month
      and then have 2-year follow-up. During starting and end of 6-month intervention, we included
      PFT during the physical examination hold in the Sir Run Run Shaw Hospital. All the subjects
      were given a standardized challenge drinker (75g glucose, 60 fat and 20g protein). Fasting
      and multiple postprandial time points samples (blood, t=0,1,3h) and urine and feces were
      collected to measure clinical and omics markers like metabolomics, gut microbiota and SNPs.
      Finally, the homeostasis index will be built to estimate improvement of individual metabolic
      health after the intervention. In conclusion, this study will provide scientific evidence and
      novel insights about the effectiveness of new intervention strategies and precise diagnostic
      and assessment system for cardiometabolic management.
    

Intervention name(s): Programmed smartphone intervention; Programmed smartphone plus dietitian intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Interactive programmed lifestyle education based on smartphone for six month; Interactive programmed lifestyle education based on smartphone plus dietitians support for six month
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: weight loss,metabolic risk, lifestyle intervention, homeostasis