Metabolic SyndromeNCT04714723
Lifestyle Intervention Trial in High Metabolic Risk Chinese
A study testing Programmed smartphone intervention and Programmed smartphone plus dietitian intervention in people with Metabolic Syndrome and Obesity, run by Chinese Academy of Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Metabolic Syndrome, Obesity
- What is being tested?
- Programmed smartphone intervention and Programmed smartphone plus dietitian intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 395 participants
- Where
- 1 siteChina
- Study dates
- 27 Dec 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Sir Run Run Shaw Hospital;Hangzhou Dianzi University;China Jiliang University; Zhejiang Sci-Tech University
Hangzhou, Zhejiang, 310016
About this study
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.
Read the 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.
- Conditions
- Metabolic Syndrome, Obesity
- Being tested
- Programmed smartphone intervention, Programmed smartphone plus dietitian intervention
- Keywords
- weight loss,metabolic risk, lifestyle intervention, homeostasis
- Medical subject headings
- Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Programmed smartphone interventionBehavioural
Interactive programmed lifestyle education based on smartphone for six month
Programmed smartphone plus dietitian interventionBehavioural
Interactive programmed lifestyle education based on smartphone plus dietitians support for six month
| Study group | Role | What they receive |
|---|---|---|
| Programmed smartphone intervention group | Active comparator | Subjects will receive programmed-smartphone lifestyle intervention Receives: Behavioral: Programmed smartphone intervention |
| Programmed smartphone plus dietitian intervention group | Experimental | Subjects will receive programmed-smartphone plus dietitian lifestyle intervention Receives: Behavioral: Programmed smartphone plus dietitian intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Weight will be assessed by Seca-255 (ScalesGalore) during each visit ,weight will also be assessed by Bluetooth scale at home
Measured: Baseline and month 6
Secondary outcomes (11)
Body mass index (BMI)
Body mass index (BMI) will be assessed by Seca-201(ScalesGalore) during each visit
Measured: Baseline and month 6
Waist circumference
Waist circumference will be assessed by Seca-201(ScalesGalore) during each visit
Measured: Baseline and month 6
Blood pressure
Both systolic pressure and diastolic pressure will be assessed using electronic blood pressure monitor (Omron J750)during each visit and at home
Measured: Baseline and month 6
Triglyceride
Values at fasting and postprandial 60min and 3hours will be measured
Measured: Baseline and month 6
Total cholesterol
Values at fasting and postprandial 60min and 3hours will be measured
Measured: Baseline and month 6
LDL-C
Values at fasting and postprandial 60min and 3hours will be measured
Measured: Baseline and month 6
HDL-C
Values at fasting and postprandial 60min and 3hours will be measured
Measured: Baseline and month 6
Glucose
Values at fasting and postprandial 60min and 3hours will be measured
Measured: Baseline and month 6
Metabolic Homeostasis Score
A metabolic homeostasis score is a composite score that includes aggregated changes in blood biomarkers (metabolites or biomarkers or index involved in carbohydrates metabolism such as glucose, C-peptide, Matsuda index etc.; metabolites or biomarkers involved in lipid metabolism such as high-density lipoprotein cholesterol, total cholesterol, triglyceride etc.; metabolites or biomarkers involved in protein/vitamin metabolism such as creatinine; inflammatory or cytokines such as interleukin-6 etc.; hormones; anthropometric measures etc.).
The metabolic homeostasis score is a composite score, that is calculated by the average of the scores of above-mentioned features using a certain computational algorithm. The larger the metabolic homeostasis score is, the worse the homeostatic resilience of the person, and vice versa.
Measured: Baseline and month 6
Body composition
Body composition will be assessed by InBody-720 multi-frequency bioelectrical impedance device.
Measured: Baseline and month 6
Compliance
Behavioral compliance will be assessed by wearable devices and bluetooth devices.
Measured: Whole 6-month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start27 Dec 2020
- Primary completion30 Nov 2021
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- Sir Run Run Shaw Hospital
- Responsible party
- Principal investigator, Xu Lin, Chinese Academy of Sciences
- Investigators
- Xu Lin, PhD, Principal investigator, Shanghai Institute of Nutrition and Health, Chinese Acadamy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714723
- Sponsor's protocol ID
- CAS-LIT-202101
- Status last verified
- Feb 2024
- First submitted
- 14 Jan 2021
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention Trial in High Metabolic Risk Chinese
- ClinicalTrials.gov ID
- NCT04714723
- Acronym / sponsor ID
- CAS-LIT-202101
- Conditions
- Metabolic Syndrome, Obesity
- Keywords
- weight loss,metabolic risk, lifestyle intervention, homeostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- Sir Run Run Shaw Hospital
- Study start
- 27 Dec 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Programmed smartphone intervention group | Active comparator | Behavioral: Programmed smartphone interventionSubjects will receive programmed-smartphone lifestyle intervention |
| Programmed smartphone plus dietitian intervention group | Experimental | Behavioral: Programmed smartphone plus dietitian interventionSubjects will receive programmed-smartphone plus dietitian lifestyle intervention |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Programmed smartphone interventionInteractive programmed lifestyle education based on smartphone for six month | Behavioural | Programmed smartphone intervention group |
| Programmed smartphone plus dietitian interventionInteractive programmed lifestyle education based on smartphone plus dietitians support for six month | Behavioural | Programmed smartphone plus dietitian intervention group |
Primary outcome
Weight
Time frame: Baseline and month 6
Weight will be assessed by Seca-255 (ScalesGalore) during each visit ,weight will also be assessed by Bluetooth scale at home
11 secondary outcomes
Body mass index (BMI)
Time frame: Baseline and month 6
Waist circumference
Time frame: Baseline and month 6
Blood pressure
Time frame: Baseline and month 6
Triglyceride
Time frame: Baseline and month 6
Total cholesterol
Time frame: Baseline and month 6
LDL-C
Time frame: Baseline and month 6
HDL-C
Time frame: Baseline and month 6
Glucose
Time frame: Baseline and month 6
Metabolic Homeostasis Score
Time frame: Baseline and month 6
Body composition
Time frame: Baseline and month 6
Compliance
Time frame: Whole 6-month intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xu Lin, PhD principal investigator
Shanghai Institute of Nutrition and Health, Chinese Acadamy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Programmed smartphone intervention and Programmed smartphone plus dietitian intervention in people with Metabolic Syndrome and Obesity, run by Chinese Academy of Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: Baseline and month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.