Lifestyle Intervention Trial in High Metabolic Risk Chinese

NCT04714723 | Completed DMC

• 1 other identifier: CAS-LIT-202101
• Study Type: interventional
• Target: 395
• Locations: 1 country
• Sites: 1

Brief 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

Metabolic Syndrome; Obesity

Keywords

weight loss,metabolic risk, lifestyle intervention, homeostasis

Outcome Measures

Primary Outcomes (1)

• Weight

  Weight will be assessed by Seca-255 (ScalesGalore) during each visit ,weight will also be assessed by Bluetooth scale at home

  Baseline and month 6

Secondary Outcomes (11)

• Body mass index (BMI)

  Baseline and month 6

• Waist circumference

  Baseline and month 6

• Blood pressure

  Baseline and month 6

• Triglyceride

  Baseline and month 6

• Total cholesterol

  Baseline and month 6

Other Outcomes (26)

• E-selectin concentration

  Baseline and month 6

• P-selectin concentration

  Baseline and month 6

• Vascular cell adhesion molecule-1(VCAM-1) concentration

  Baseline and month 6

Study Arms (2)

Programmed smartphone intervention group

ACTIVE COMPARATOR

Subjects will receive programmed-smartphone lifestyle intervention

Behavioral: Programmed smartphone intervention

Programmed smartphone plus dietitian intervention group

EXPERIMENTAL

Subjects will receive programmed-smartphone plus dietitian lifestyle intervention

Behavioral: Programmed smartphone plus dietitian intervention

Interventions

Programmed smartphone intervention BEHAVIORAL

Interactive programmed lifestyle education based on smartphone for six month

Programmed smartphone intervention group

Programmed smartphone plus dietitian intervention BEHAVIORAL

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

Programmed smartphone plus dietitian intervention group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers at high metabolic risk aged 20-65 who didn't participate in other studies in 3 months before the current research, having a certain level of education and normal cognitive ability, taking good care of himself/herself. MetS risk factors were identified by the definition proposed by the International Diabetes Federation criteria for Chinese adults. Participants should have central obesity (waist circumference ≥90 cm in men or ≥80 cm in women).

You may not qualify if:

• Fasting glucose\>7.0mmol/L after taking insulin or other blood glucose-lowering drugs
• Diagnosed phase three hypertension or can't lowering SBP under 160mmHg after anti-hypertension drugs
• Fasting blood TG≥ 5.7 mmol/L or fasting LDL-C≥ 4.9 mmol/L after taking lipid-lowering drugs
• Pregnancy or lactation
• Obvious drug changing in three months before research
• History of drug or alcohol abuse or other substance abuse (Alcohol abuse is defined as more than 40 g/day of alcohol for woman, and more than 80g/day for man)
• Severe kidney and liver diseases (blood biomarkers such as alt, serum creatinine is 1.5 times over the scope of normal setting)
• Severe Gastrointestinal diseases (such as severe diarrhea, constipation, severe digestive tract inflammation, active peptic ulcer, acute cholecystitis, etc.)
• Having surgeries within one year before research such as heart stents implanted surgery (expect for appendicitis or hernia operation)
• Severe cardiovascular disease (e.g., heart failure, myocardial infarction, cerebral infarction, and acute myocarditis, severe arrhythmia, received the intervention therapy, etc.)
• Cancer or receiving radiotherapy and chemotherapy within 5 years
• Severe pituitary or thyroid diseases
• Suffering from AIDS, hepatitis A, hepatitis B and other infectious diseases
• Mental disorders or current use of antidepressants

Sponsors & Collaborators

• Chinese Academy of Sciences: lead
• Sir Run Run Shaw Hospital: collaborator

Study Sites (1)

Sir Run Run Shaw Hospital;Hangzhou Dianzi University;China Jiliang University; Zhejiang Sci-Tech University

Hangzhou, Zhejiang, 310016, China

Location

MeSH Terms

Conditions

Metabolic Syndrome; Obesity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xu Lin, PhD

  Shanghai Institute of Nutrition and Health, Chinese Acadamy of Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 19, 2021
• Study Start: December 27, 2020
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

CN (1)