NCT04714723Completed
Lifestyle Intervention Trial in High Metabolic Risk Chinese
Source: ClinicalTrials.gov · Last updated 9 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 395 (actual)
- First submitted
- 14 Jan 2021
- Start date
- 27 Dec 2020
- Primary completion date
- 30 Nov 2021
- Lead sponsor
- Chinese Academy of Sciences
- Diseases
- Obesity
- NCT number
- NCT04714723
What you commit to
- Study type: Interventional
- Participants enrolled: 395
- From 27 Dec 2020 to the primary completion date, 30 Nov 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Obvious drug changing in three months before research
- 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
Other illness
- Diagnosed phase three hypertension or can't lowering SBP under 160mmHg after anti-hypertension drugs
- 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 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 pituitary or thyroid diseases
- Suffering from AIDS, hepatitis A, hepatitis B and other infectious diseases
- Mental disorders or current use of antidepressants
Lab values
- Fasting glucose\>7.0mmol/L after taking insulin or other blood glucose-lowering drugs
- Fasting blood TG≥ 5.7 mmol/L or fasting LDL-C≥ 4.9 mmol/L after taking lipid-lowering drugs
- Severe kidney and liver diseases (blood biomarkers such as alt, serum creatinine is 1.5 times over the scope of normal setting)
Other
- Pregnancy or lactation
Who the study is looking for
- 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).
Age in the registry: 20 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sir Run Run Shaw Hospital;Hangzhou Dianzi University;China Jiliang University; Zhejiang Sci-Tech University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.