Overweight/ObesityNCT06147752
Mobile Internet Healthcare and Three Disciplines Co-management Intervention for Overweight/Obese Prediabetic Patients
A study testing mobile internet healthcare and "co-management of three disciplines" in people with Overweight/Obesity and Prediabetes, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
Diabetes mellitus is a chronic metabolic disease associated with a high rate of disability and mortality. Prediabetes is the intermediate stage from normal blood glucose to diabetes. Reversal of prediabetes can help reduce the incidence of related complications and reduce premature mortality. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Overweight/Obesity, Prediabetes, Weight Management
- What is being tested?
- mobile internet healthcare and "co-management of three disciplines"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2023to Mar 2025
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ①18 years≤ Age<70 years
- 5.7mmol/L≤ fasting blood glucose <6.9mmol/L
- 7.8mmol/L≤2h blood glucose <11.0mmol/L;
- 24Kg/m2≤BMI≤45Kg/m2
Who cannot join
- Diagnosed diabetes
- In the past 3 months, metformin, thiazolidinedione, acarbose and weight reduction drugs were used
- Severe infection, severe trauma or other stress
- The weight fluctuation in the past 3 months was >5%
- Aspartate Transaminase(AST) or Alanine Aminotransferase（ALT） increased the upper limit of 3 times the normal value; Creatinine greater than 1.5 times the upper limit of normal; Estimated Glomerular Filtration Rate（eGFR） 30 ml/min / 1.73 m2 or less
- Serious cardiovascular and cerebrovascular disease in the past 6 months
- Abnormal thyroid function not controlled;
- Pregnant and breastfeeding women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
xin zheng, 18705929102, zx2001528@163.com
About this study
Official title: Department of Endocrinology and Diabetes, Xiamen Diabetes Institute, Fujian Province Key Laboratory of Translational Research for Diabetes, The First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen, China
Diabetes mellitus is a chronic metabolic disease associated with a high rate of disability and mortality. Prediabetes is the intermediate stage from normal blood glucose to diabetes. Reversal of prediabetes can help reduce the incidence of related complications and reduce premature mortality. Therefore, the early treatment of prediabetes is crucial, detection and effective management of this large population in time is the key to prevent diabetes.
Overweight/obesity is one of the key risk factors leading to prediabetes and diabetes. In order to delay the progression of prediabetes and prevent related complications, weight loss is a key strategy to reverse prediabetes in overweight/obese patients. Lifestyle intervention is the first-line treatment for weight loss and is the most suitable intervention method. Although weight loss has been shown to have many metabolic benefits, it is a great challenge in the real world due to the long-term and complex of weight management.
Read more
In order to further optimize the weight loss treatment of prediabetic patients, the study apply the mobile internet intelligent healthcare big data technology, 100 overweight/obese prediabetic patients who met the enrollment conditions were randomly divided into control group and intervention group by 1:1, with 50 patients in each group. The control group was treated according to the traditional diagnosis and treatment mode, and the diagnosis and treatment plan was formulated by the endocrinologist, and the diet education was conducted by the dietitian, and the individualized diet plan was formulated. Given a calorie-restricted diet, it is recommended to reduce daily energy intake by 500kcal on the basis of requirement. At least 150 minutes of moderate-intensity exercise per week is recommended. After the visit, the patient underwent follow-up self-weight monitoring and diet management outside the hospital. The intervention group was managed by co-management of three disciplines (endocrinologists, dietitians and weight managers). The three disciplines team tracked and assessed the patients' daily diet and weight changes, and gave guidance. The duration of intervention was 6 months.
To explore the impact of the new model of mobile internet healthcare and "three disciplines co-management" on overweight/obese prediabetic patients, and whether it can improve the weight, glycemic and lipid metabolism and insulin resistance, and compare the reversal rate of prediabetes in the two groups.
Read the detailed description
Sample size estimation The sample size was calculated based on the primary clinical endpoint and previous relevant clinical studies, which met 90% detection efficacy, with an a-value of 0.05 on both sides and a follow-up rate of more than 80%. 100 overweight/obese prediabetic patients were enrolled in the Department of Endocrinology and Diabetes The First Affiliated Hospital of Xiamen University.
Recruitment:
The researcher informs the patient about the study; If patients agree to participate in the study, they will need to sign an informed consent form with their doctor. The study doctor will ask and record the medical history, do physical examination, such as measuring height, weight, waist circumference, blood pressure, laboratory tests, finally determine the enrollment conditions and complete the randomized grouping. A total of 140 participants were recruited, 100 participants were finally enrolled and randomly divided into control group and intervention group according to 1:1.
Management mode:
Informed consent was signed at the first admission, and the researcher and patients were fully communicated, so that patients could realize the importance of out-of-hospital lifestyle management in reversing prediabetes. Dietitians provide detailed one-to-one guidance to each patient, using food models, pictures and other tools to guide, including food diary recording , food intake estimation, food exchange serving, nutrition label reading. Weight managers guide patients to proficiently use mobile healthcare apps, increase their attention to online communication, increase the frequency of use of online platforms for out-of-hospital care, real-time upload diet, exercise and weight monitoring indicators, respond to patient consultation in time so as to improve interaction and compliance with patients. To give full play to the effect of service management, researchers will also remind and urge patients to use apps through telephone, wechat and other ways to improve compliance.
Quality control:
- Unified training of investigators, including program implementation, questionnaire survey, etc., to ensure unified methods in the investigation process.
- All researcher have undergone unified training, including diagnostic standards, evaluation guidance, record norms, etc.
- Epidata was used to build the database, and all data were entered in parallel by two people, with automatic and manual double verification.
- Conditions
- Overweight/Obesity, Prediabetes, Weight Management
- Being tested
- mobile internet healthcare and "co-management of three disciplines"
- Medical subject headings
- Overweight, Obesity, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile internet healthcare and "co-management of three disciplines"Behavioural
"co-management of three disciplines":
Endocrinologist:
Assess disease status and rule out secondary obesity; Identify the causes of overweight/obesity and the status and extent of associated diseases; receive patients for return visits. Timely reply to patients' questions on the mobile medical platform, and timely adjust medication plans according to changes in patients' conditions.
Dietitians:
Conduct diet assessment, develop personalized medicine nutrition treatment plan and provide daily real-time guidance and follow up patients' daily diet outside the hospital.
Weight managers:
Establish weight loss record for patients, guide the installation and use of mobile medical Application , including weight monitoring, real-time uploading of daily diet and online interactive consultation; Follow up patients' weight changes; Assist patients in making appointments for follow-up visits.
| Study group | Role | What they receive |
|---|---|---|
| Mobile internet healthcare treatment and "three disciplines co-management" | Experimental | 100 patients who met the enrollment conditions were randomly divided into control group and intervention group by 1:1. The intervention group adopted the intervention of mobile Internet healthcare and "co-management of three disciplines" (endocrinologists, dietitians and weight managers). The three disciplines team tracked and assessed the patients' daily diet and weight changes. The duration of intervention was 6 months. Receives: Behavioral: mobile internet healthcare and "co-management of three disciplines" |
| Traditional diagnosis and treatment mode | Experimental | 100 patients who met the enrollment conditions were randomly divided into control group and intervention group by 1:1. The control group was treated according to the traditional mode: the diagnosis and treatment plan was formulated by the endocrinologist, and the diet education was conducted by the dietitian, and the individualized diet plan was formulated. Given a calorie-restricted diet, it is recommended to reduce daily energy intake by 500kcal on the basis of requirement. At least 150 minutes of moderate-intensity exercise per week is recommended. After the visit, the patient underwent follow-up self-weight monitoring and diet management outside the hospital. Receives: Behavioral: mobile internet healthcare and "co-management of three disciplines" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of weight
Whether there was a significant difference in weight change between the intervention and control groups
Measured: After 6 months of intervention, the change of weight was compared between the two groups
Reversal rate of prediabetes
Whether there was a significant difference in the reversal rate of prediabetes between the intervention and control groups
Measured: After 6 months of intervention, the reversal rate of prediabetes was compared between the two groups
Change of homeostasis model assessment-insulin resistance（HOMA-IR）
Whether there was a significant difference in HOMA-IR change between the intervention and control groups
Measured: After 6 months of intervention, the change of HOMA-IR was compared between the two groups
Secondary outcomes (4)
Change of BMI
Whether there was a significant difference in BMI change between the intervention and control groups
Measured: After 6 months of intervention, the change of BMI was compared between the two groups
Change of waistline
Whether there was a significant difference in waistline change between the intervention and control groups
Measured: After 6 months of intervention, the change of waistline was compared between the two groups
Change of serum lipid level
Whether there was a significant difference in serum lipid level change between the intervention and control groups
Measured: After 6 months of intervention, the change of serum lipid level was compared between the two groups
Change of hepatic steatosis value
Whether there was a significant difference in hepatic steatosis value change between the intervention and control groups
Measured: After 6 months of intervention, the change of hepatic steatosis value was compared between the two groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start28 Mar 2023
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight/ObesityStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zheng xin, The First Affiliated Hospital of Xiamen University
- Investigators
- xin zheng, Study director, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147752
- Sponsor's protocol ID
- 3502Z20224ZD1027
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Endocrinology and Diabetes, Xiamen Diabetes Institute, Fujian Province Key Laboratory of Translational Research for Diabetes, The First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen, China
- ClinicalTrials.gov ID
- NCT06147752
- Acronym / sponsor ID
- 3502Z20224ZD1027
- Conditions
- Overweight/Obesity, Prediabetes, Weight Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 28 Nov 2023 (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.
Diabetes mellitus is a chronic metabolic disease associated with a high rate of disability and mortality. Prediabetes is the intermediate stage from normal blood glucose to diabetes. Reversal of prediabetes can help reduce the incidence of related complications and reduce premature mortality. Therefore, the early treatment of prediabetes is crucial, detection and effective management of this large population in time is the key to prevent diabetes.
Overweight/obesity is one of the key risk factors leading to prediabetes and diabetes. In order to delay the progression of prediabetes and prevent related complications, weight loss is a key strategy to reverse prediabetes in overweight/obese patients. Lifestyle intervention is the first-line treatment for weight loss and is the most suitable intervention method. Although weight loss has been shown to have many metabolic benefits, it is a great challenge in the real world due to the long-term and complex of weight management.
In order to further optimize the weight loss treatment of prediabetic patients, the study apply the mobile internet intelligent healthcare big data technology, 100 overweight/obese prediabetic patients who met the enrollment conditions were randomly divided into control group and intervention group by 1:1, with 50 patients in each group. The control group was treated according to the traditional diagnosis and treatment mode, and the diagnosis and treatment plan was formulated by the endocrinologist, and the diet education was conducted by the dietitian, and the individualized diet plan was formulated. Given a calorie-restricted diet, it is recommended to reduce daily energy intake by 500kcal on the basis of requirement. At least 150 minutes of moderate-intensity exercise per week is recommended. After the visit, the patient underwent follow-up self-weight monitoring and diet management outside the hospital. The intervention group was managed by co-management of three disciplines (endocrinologists, dietitians and weight managers). The three disciplines team tracked and assessed the patients' daily diet and weight changes, and gave guidance. The duration of intervention was 6 months.
To explore the impact of the new model of mobile internet healthcare and "three disciplines co-management" on overweight/obese prediabetic patients, and whether it can improve the weight, glycemic and lipid metabolism and insulin resistance, and compare the reversal rate of prediabetes in the two groups.
Detailed description
Sample size estimation The sample size was calculated based on the primary clinical endpoint and previous relevant clinical studies, which met 90% detection efficacy, with an a-value of 0.05 on both sides and a follow-up rate of more than 80%. 100 overweight/obese prediabetic patients were enrolled in the Department of Endocrinology and Diabetes The First Affiliated Hospital of Xiamen University.
Recruitment:
The researcher informs the patient about the study; If patients agree to participate in the study, they will need to sign an informed consent form with their doctor. The study doctor will ask and record the medical history, do physical examination, such as measuring height, weight, waist circumference, blood pressure, laboratory tests, finally determine the enrollment conditions and complete the randomized grouping. A total of 140 participants were recruited, 100 participants were finally enrolled and randomly divided into control group and intervention group according to 1:1.
Management mode:
Informed consent was signed at the first admission, and the researcher and patients were fully communicated, so that patients could realize the importance of out-of-hospital lifestyle management in reversing prediabetes. Dietitians provide detailed one-to-one guidance to each patient, using food models, pictures and other tools to guide, including food diary recording , food intake estimation, food exchange serving, nutrition label reading. Weight managers guide patients to proficiently use mobile healthcare apps, increase their attention to online communication, increase the frequency of use of online platforms for out-of-hospital care, real-time upload diet, exercise and weight monitoring indicators, respond to patient consultation in time so as to improve interaction and compliance with patients. To give full play to the effect of service management, researchers will also remind and urge patients to use apps through telephone, wechat and other ways to improve compliance.
Quality control:
- Unified training of investigators, including program implementation, questionnaire survey, etc., to ensure unified methods in the investigation process.
- All researcher have undergone unified training, including diagnostic standards, evaluation guidance, record norms, etc.
- Epidata was used to build the database, and all data were entered in parallel by two people, with automatic and manual double verification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile internet healthcare treatment and "three disciplines co-management" | Experimental | Behavioral: mobile internet healthcare and "co-management of three disciplines"100 patients who met the enrollment conditions were randomly divided into control group and intervention group by 1:1. The intervention group adopted the intervention of mobile Internet healthcare and "co-management of three disciplines" (endocrinologists, dietitians and weight managers). The three disciplines team tracked and assessed the patients' daily diet and weight changes. The duration of intervention was 6 months. |
| Traditional diagnosis and treatment mode | Experimental | Behavioral: mobile internet healthcare and "co-management of three disciplines"100 patients who met the enrollment conditions were randomly divided into control group and intervention group by 1:1. The control group was treated according to the traditional mode: the diagnosis and treatment plan was formulated by the endocrinologist, and the diet education was conducted by the dietitian, and the individualized diet plan was formulated. Given a calorie-restricted diet, it is recommended to reduce daily energy intake by 500kcal on the basis of requirement. At least 150 minutes of moderate-intensity exercise per week is recommended. After the visit, the patient underwent follow-up self-weight monitoring and diet management outside the hospital. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ①18 years≤ Age<70 years
- 5.7mmol/L≤ fasting blood glucose <6.9mmol/L
Key exclusion criteria (8 listed)
- Diagnosed diabetes
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 |
|---|---|---|
| mobile internet healthcare and "co-management of three disciplines""co-management of three disciplines": Endocrinologist: Assess disease status and rule out secondary obesity; Identify the causes of overweight/obesity and the status and extent of associated diseases; receive patients for return visits. Timely reply to patients' questions on the mobile medical platform, and timely adjust medication plans according to changes in patients' conditions. Dietitians: Conduct diet assessment, develop personalized medicine nutrition treatment plan and provide daily real-time guidance and follow up patients' daily diet outside the hospital. Weight managers: Establish weight loss record for patients, guide the installation and use of mobile medical Application , including weight monitoring, real-time uploading of daily diet and online interactive consultation; Follow up patients' weight changes; Assist patients in making appointments for follow-up visits. | Behavioural | Mobile internet healthcare treatment and "three disciplines co-management", Traditional diagnosis and treatment mode |
Primary outcome
Change of weight
Time frame: After 6 months of intervention, the change of weight was compared between the two groups
Whether there was a significant difference in weight change between the intervention and control groups
Reversal rate of prediabetes
Time frame: After 6 months of intervention, the reversal rate of prediabetes was compared between the two groups
Whether there was a significant difference in the reversal rate of prediabetes between the intervention and control groups
Change of homeostasis model assessment-insulin resistance（HOMA-IR）
Time frame: After 6 months of intervention, the change of HOMA-IR was compared between the two groups
Whether there was a significant difference in HOMA-IR change between the intervention and control groups
4 secondary outcomes
Change of BMI
Time frame: After 6 months of intervention, the change of BMI was compared between the two groups
Change of waistline
Time frame: After 6 months of intervention, the change of waistline was compared between the two groups
Change of serum lipid level
Time frame: After 6 months of intervention, the change of serum lipid level was compared between the two groups
Change of hepatic steatosis value
Time frame: After 6 months of intervention, the change of hepatic steatosis value was compared between the two groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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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.
xin zheng study director
The First Affiliated Hospital of Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile internet healthcare and "co-management of three disciplines" in people with Overweight/Obesity and Prediabetes, run by The First Affiliated Hospital of Xiamen University 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 28 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xin zheng (18705929102, zx2001528@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of weight (time frame: After 6 months of intervention, the change of weight was compared between the two groups). The study lists 3 primary outcomes in all. 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 28 Nov 2023.