Diabetes Mellitus, Type 2NCT05561855
T2DM Intensity Lifestyle Intervention
A study testing lifestyle intervention in people with Diabetes Mellitus, Type 2 and Overweight or Obesity, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
This RCT study will evaluate the effect of a lifestyle intervention on overweight or obese patients with type 2 diabetes mellitus. The primary hypothesis is that the mHealth-based intensive lifestyle intervention is sufficient to achieve weight loss and maintain glycated hemoglobin control. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Overweight or Obesity
- What is being tested?
- lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 7 Oct 2022to 1 Jul 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the WHO diagnostic criteria for type 2 diabetes;
- The duration of diabetes is less than 5 years;
- HbA1c was between 6.5-11% in recent 3 months;
- 18-65 years old;
- 24kg/m2≤BMI#40kg/m2;
- Weight loss within the past 3 months did not exceed 5% of initial weight;
- Currently using a smartphone;
- Voluntary participation.
Who cannot join
- Pregnant or lactating woman, or planning a pregnancy within 6 months after recruitment;
- Uncontrolled hypertension (resting blood pressure ≥ 160/100mmHg);
- Treatment with insulin;
- Acute complications of diabetes (diabetic ketoacidosis, hyperosmolar state, infection. etc) have occurred within the past 3 months, or one or more severe chronic complications of diabetes have existed, such as severe cardiovascular or cerebrovascular pathology (angina pectoris, myocardial infarction, grade III-IV heart failure, severe arrhythmia, transient cerebral ischemic attack, stroke, etc.), massive proteinuria (urinary albumin/creatinine ratio ≥300 mg/g), and severe diabetic foot, severe neuropathy, blurred vision.
- Currently using weight-reducing products such as orlistat, or other medications that can significantly affect weight such as diuretics and hormones;
- Severe cardiovascular and cerebrovascular diseases, respiratory diseases, hepatic and renal insufficiency, malignant tumors and other chronic consumptive diseases, active infections, and surgical history involving important organs within 3 months;
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- Contraindications to physical activity;
- The presence of mental or cognitive impairment;
- Current participation in other clinical trial projects;
- Having the same family member involved in the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of mHealth-Based Lifestyle Intervention on Overweight or Obese Patients With Type 2 Diabetes: A Randomized Controlled Trial
This RCT study will evaluate the effect of a lifestyle intervention on overweight or obese patients with type 2 diabetes mellitus. The primary hypothesis is that the mHealth-based intensive lifestyle intervention is sufficient to achieve weight loss and maintain glycated hemoglobin control.
Read the detailed description
Diabetes mellitus is a chronic systemic metabolic disease caused by the long-term interaction of genetic factors and environmental factors. It is characterized by an increase in plasma glucose levels and is mainly due to metabolic disorders in glucose, fat, and protein caused by insufficient insulin secretion and/or dysfunction in the body, which affects normal physiological activities. As of 2019, 463 million people are suffering from diabetes in the world, of which 90% to 95% have type 2 diabetes mellitus (T2DM), with an average of 1 patient in every 11 adults (aged 20-79). The number of patients with T2DM will jump to 700 million by 2045. There is a close relationship between T2DM and overweight and obesity. The prevalence of diabetes in overweight and obese people in China was 12.8% and 18.5%, respectively. Among T2DM patients, the proportions of overweight and obesity were 41% and 24.3%, respectively.The two kinds of diseases share a common key pathophysiological mechanism, which will have a devastating long-term impact on patients' health and bring serious disease and economic burden to the family. Given the various harms, it is urgent to carry out relevant intervention research and formulate effective intervention strategies. With the development of artificial intelligence technology, the combination of mHealth and multidisciplinary lifestyle intervention may become an efficient and easy-to-popularize management mode for the prevention and treatment of T2DM with obesity.
Given the relative lack of high-quality interventions for T2DM overweight/obesity, the investigators designed a randomized controlled trial to assess the effectiveness of a multicomponent intervention in Ningbo First Hospital. This study plans to adopt the online and offline combination method based on mHealth technology to carry out lifestyle intervention aimed at formulating a set of feasible and effective intervention strategies.
The study aims to identify: 1) whether the mHealth-based intensive lifestyle intervention will be effective for weight and glycated hemoglobin management to reverse or slow down the disease process among T2DM patients with overweight/obesity; 2) whether the intervention will be beneficial for improving biochemical indicators, body composition indicators, and exercise capacity among T2DM patients with overweight/obesity.
- Conditions
- Diabetes Mellitus, Type 2, Overweight or Obesity
- Being tested
- lifestyle intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle interventionBehavioural
During the 3-month lifestyle intervention period, the participants need to complete the weight monitoring, behavioral goal recording, diet and exercise recording, online course learning by using the WeChat official account module of "Weight Loss and Glucose Control".They will receive corresponding feedback and integral rewards every week, and receive monthly follow-ups to complete health education, goal review, motivational interview as well as collecting medication changes and blood glucose monitoring data.
| Study group | Role | What they receive |
|---|---|---|
| lifestyle intervention | Experimental | 1. Weight monitoring: Participants are required to record the weighting data in the WeChat official account at least once a week to lose 5% or more of their initial body weight in 3 months.
2. Goals record: At baseline, the participants need to complete a behavioral goals questionnaire. All these behaviors are then ranked for each participant based on an algorithm that determines the participants'self-reported necessity, self-efficacy, and estimated caloric deficit from performing that behavior. The top six goals are assigned to each participant with two for every 4-week cycle.
3. Exercise: The form is the combination of aerobic exercise (3d/w) and resistance exercise(2d/w). Each participant will be equipped with a Huami watch as a means of monitoring.
4. Health education: Participants are provided with T2DM-related knowledge. They can also contact the endocrinologist online and offline. Receives: Behavioral: lifestyle intervention |
| usual-care control | No intervention | Participants assigned to the control group will receive routine medical care and diabetes education, and be treated with hypoglycemic drugs under the guidance of endocrinologists according to the patient's condition and clinical treatment standards throughout their participation in the trial. After finishing the study, they will be offered healthy management as the participants in the multi-component lifestyle intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change from baseline
measured in kilograms (kg) and calculate the change percentage(%)
Measured: at end of the 3-month intervention
The change of HbA1c from baseline
measured in percent (%)
Measured: at end of the 3-month intervention
Secondary outcomes (11)
The change in body mass index (BMI) from baseline
Weight and height will be combined to report BMI in kg/m^2.
Measured: at end of the 3-month intervention
The change of waist circumference from baseline
measured in centimetre (cm)
Measured: at end of the 3-month intervention
The change of waist-to-hip circumference ratio from baseline
measure waist circumference and hip circumference to calculate waist-to-hip circumference ratio
Measured: at end of the 3-month intervention
The change of both systolic and diastolic blood pressures from baseline
measure systolic and diastolic blood pressure in millimeters of mercury (mmHg) by using electronic sphygmomanometer
Measured: at end of the 3-month intervention
The change of body fat percentage from baseline
measure body fat percentage (%) by bioelectrical impedance analysis
Measured: at end of the 3-month intervention
The change of blood lipids from baseline
measure total cholesterol, triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol in milligram/deciliter (mg/dL)
Measured: at end of the 3-month intervention
The change in muscle strength from baseline
measure grip strength in kilograms (kg) by hand dynamometer
Measured: at end of the 3-month intervention
The change in exercise capacity from baseline
The 3-Minute Step Test is an assessment for Cardiorespiratory Fitness. At the end of the 3 minutes, sit down and monitor the pulse for one full minute. Calculate step-test index with the recovery heart rate. The fitter you are, the quicker the heart rate will return to normal after exercise.
Measured: at end of the 3-month intervention
The change in life quality from baseline
It is measured in the form of the Short form health survey (SF-36), scored from 0 to 100, with higher scores associated with better quality of life.
Measured: at end of the 3-month intervention
The change in sleep quality from baseline
It is measured in the form of the Pittsburgh Sleep Quality Index (PSQI), scored from 0 to 21, with higher scores associated with worse quality of sleep.
Measured: at end of the 3-month intervention
The change in depression severity from baseline
It is measured in the form of the Pittsburgh Sleep Quality Index (PSQI), scored from 0 to 27, with higher scores associated with greater degree of depression.
Measured: at end of the 3-month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start7 Oct 2022
- Primary completion1 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University
- Responsible party
- Sponsor
- Investigators
- Li Li, Bachelor, Principal investigator, Ningbo No. 1 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561855
- Sponsor's protocol ID
- NBFH20220755
- Status last verified
- Nov 2023
- First submitted
- 22 Sep 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of mHealth-Based Lifestyle Intervention on Overweight or Obese Patients With Type 2 Diabetes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05561855
- Acronym / sponsor ID
- NBFH20220755
- Conditions
- Diabetes Mellitus, Type 2, Overweight or Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Collaborators
- Peking University
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 30 Sep 2022 (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.
This RCT study will evaluate the effect of a lifestyle intervention on overweight or obese patients with type 2 diabetes mellitus. The primary hypothesis is that the mHealth-based intensive lifestyle intervention is sufficient to achieve weight loss and maintain glycated hemoglobin control.
Detailed description
Diabetes mellitus is a chronic systemic metabolic disease caused by the long-term interaction of genetic factors and environmental factors. It is characterized by an increase in plasma glucose levels and is mainly due to metabolic disorders in glucose, fat, and protein caused by insufficient insulin secretion and/or dysfunction in the body, which affects normal physiological activities. As of 2019, 463 million people are suffering from diabetes in the world, of which 90% to 95% have type 2 diabetes mellitus (T2DM), with an average of 1 patient in every 11 adults (aged 20-79). The number of patients with T2DM will jump to 700 million by 2045. There is a close relationship between T2DM and overweight and obesity. The prevalence of diabetes in overweight and obese people in China was 12.8% and 18.5%, respectively. Among T2DM patients, the proportions of overweight and obesity were 41% and 24.3%, respectively.The two kinds of diseases share a common key pathophysiological mechanism, which will have a devastating long-term impact on patients' health and bring serious disease and economic burden to the family. Given the various harms, it is urgent to carry out relevant intervention research and formulate effective intervention strategies. With the development of artificial intelligence technology, the combination of mHealth and multidisciplinary lifestyle intervention may become an efficient and easy-to-popularize management mode for the prevention and treatment of T2DM with obesity.
Given the relative lack of high-quality interventions for T2DM overweight/obesity, the investigators designed a randomized controlled trial to assess the effectiveness of a multicomponent intervention in Ningbo First Hospital. This study plans to adopt the online and offline combination method based on mHealth technology to carry out lifestyle intervention aimed at formulating a set of feasible and effective intervention strategies.
The study aims to identify: 1) whether the mHealth-based intensive lifestyle intervention will be effective for weight and glycated hemoglobin management to reverse or slow down the disease process among T2DM patients with overweight/obesity; 2) whether the intervention will be beneficial for improving biochemical indicators, body composition indicators, and exercise capacity among T2DM patients with overweight/obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lifestyle intervention | Experimental | Behavioral: lifestyle intervention1. Weight monitoring: Participants are required to record the weighting data in the WeChat official account at least once a week to lose 5% or more of their initial body weight in 3 months. 2. Goals record: At baseline, the participants need to complete a behavioral goals questionnaire. All these behaviors are then ranked for each participant based on an algorithm that determines the participants'self-reported necessity, self-efficacy, and estimated caloric deficit from performing that behavior. The top six goals are assigned to each participant with two for every 4-week cycle. 3. Exercise: The form is the combination of aerobic exercise (3d/w) and resistance exercise(2d/w). Each participant will be equipped with a Huami watch as a means of monitoring. 4. Health education: Participants are provided with T2DM-related knowledge. They can also contact the endocrinologist online and offline. |
| usual-care control | No intervention | –Participants assigned to the control group will receive routine medical care and diabetes education, and be treated with hypoglycemic drugs under the guidance of endocrinologists according to the patient's condition and clinical treatment standards throughout their participation in the trial. After finishing the study, they will be offered healthy management as the participants in the multi-component lifestyle intervention group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Meet the WHO diagnostic criteria for type 2 diabetes;
- The duration of diabetes is less than 5 years;
- HbA1c was between 6.5-11% in recent 3 months;
- 18-65 years old;
- 24kg/m2≤BMI#40kg/m2;
Key exclusion criteria (10 listed)
- Pregnant or lactating woman, or planning a pregnancy within 6 months after recruitment;
- Uncontrolled hypertension (resting blood pressure ≥ 160/100mmHg);
- Treatment with insulin;
- Acute complications of diabetes (diabetic ketoacidosis, hyperosmolar state, infection. etc) have occurred within the past 3 months, or one or more severe chronic complications of diabetes have existed, such as severe cardiovascular or cerebrovascular pathology (angina pectoris, myocardial infarction, grade III-IV heart failure, severe arrhythmia, transient cerebral ischemic attack, stroke, etc.), massive proteinuria (urinary albumin/creatinine ratio ≥300 mg/g), and severe diabetic foot, severe neuropathy, blurred vision.
- Currently using weight-reducing products such as orlistat, or other medications that can significantly affect weight such as diuretics and hormones;
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 |
|---|---|---|
| lifestyle interventionDuring the 3-month lifestyle intervention period, the participants need to complete the weight monitoring, behavioral goal recording, diet and exercise recording, online course learning by using the WeChat official account module of "Weight Loss and Glucose Control".They will receive corresponding feedback and integral rewards every week, and receive monthly follow-ups to complete health education, goal review, motivational interview as well as collecting medication changes and blood glucose monitoring data. | Behavioural | lifestyle intervention |
Primary outcome
Weight change from baseline
Time frame: at end of the 3-month intervention
measured in kilograms (kg) and calculate the change percentage(%)
The change of HbA1c from baseline
Time frame: at end of the 3-month intervention
measured in percent (%)
11 secondary outcomes
The change in body mass index (BMI) from baseline
Time frame: at end of the 3-month intervention
The change of waist circumference from baseline
Time frame: at end of the 3-month intervention
The change of waist-to-hip circumference ratio from baseline
Time frame: at end of the 3-month intervention
The change of both systolic and diastolic blood pressures from baseline
Time frame: at end of the 3-month intervention
The change of body fat percentage from baseline
Time frame: at end of the 3-month intervention
The change of blood lipids from baseline
Time frame: at end of the 3-month intervention
The change in muscle strength from baseline
Time frame: at end of the 3-month intervention
The change in exercise capacity from baseline
Time frame: at end of the 3-month intervention
The change in life quality from baseline
Time frame: at end of the 3-month intervention
The change in sleep quality from baseline
Time frame: at end of the 3-month intervention
The change in depression severity from baseline
Time frame: at end of the 3-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 18 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.
Li Li, Bachelor principal investigator
Ningbo No. 1 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle intervention in people with Diabetes Mellitus, Type 2 and Overweight or Obesity, run by Ningbo No. 1 Hospital 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 8 inclusion and 10 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 18 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?
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 change from baseline (time frame: at end of the 3-month intervention). The study lists 2 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 18 Nov 2023.