T2DM Intensity Lifestyle Intervention

Not Applicable

Completed

• Conditions: Overweight or Obesity; Diabetes Mellitus, Type 2
• Interventions: Behavioral: lifestyle intervention

• Registration Number: NCT05561855
• Lead Sponsor: Ningbo No. 1 Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2022-09-22
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-30
• Study Start: 2022-10-07
• Primary Completion: 2023-06-01
• Study Completion: 2023-07-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Meet the WHO diagnostic criteria for type 2 diabetes;
2. The duration of diabetes is less than 5 years;
3. HbA1c was between 6.5-11% in recent 3 months;
4. 18-65 years old;
5. 24kg/m2≤BMI#40kg/m2;
6. Weight loss within the past 3 months did not exceed 5% of initial weight;
7. Currently using a smartphone;
8. Voluntary participation.

Exclusion Criteria

1. Pregnant or lactating woman, or planning a pregnancy within 6 months after recruitment;
2. Uncontrolled hypertension (resting blood pressure ≥ 160/100mmHg);
3. Treatment with insulin;
4. 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.
5. Currently using weight-reducing products such as orlistat, or other medications that can significantly affect weight such as diuretics and hormones;
6. 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;
7. Contraindications to physical activity;
8. The presence of mental or cognitive impairment;
9. Current participation in other clinical trial projects;
10. Having the same family member involved in the research.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lifestyle intervention	lifestyle intervention	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.

Primary Outcome Measures

Name	Time	Method
Weight change from baseline	at end of the 3-month intervention	measured in kilograms (kg) and calculate the change percentage(%)
The change of HbA1c from baseline	at end of the 3-month intervention	measured in percent (%)

Secondary Outcome Measures

Name	Time	Method
The change of waist-to-hip circumference ratio from baseline	at end of the 3-month intervention	measure waist circumference and hip circumference to calculate waist-to-hip circumference ratio
The change of both systolic and diastolic blood pressures from baseline	at end of the 3-month intervention	measure systolic and diastolic blood pressure in millimeters of mercury (mmHg) by using electronic sphygmomanometer
The change in exercise capacity from baseline	at end of the 3-month intervention	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.
The change in life quality from baseline	at end of the 3-month intervention	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.
The change in depression severity from baseline	at end of the 3-month intervention	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.
The change in body mass index (BMI) from baseline	at end of the 3-month intervention	Weight and height will be combined to report BMI in kg/m\^2.
The change of waist circumference from baseline	at end of the 3-month intervention	measured in centimetre (cm)
The change of body fat percentage from baseline	at end of the 3-month intervention	measure body fat percentage (%) by bioelectrical impedance analysis
The change of blood lipids from baseline	at end of the 3-month intervention	measure total cholesterol, triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol in milligram/deciliter (mg/dL)
The change in muscle strength from baseline	at end of the 3-month intervention	measure grip strength in kilograms (kg) by hand dynamometer
The change in sleep quality from baseline	at end of the 3-month intervention	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.

Trial Locations

Locations (1)

Ningbo First Hospital; 🇨🇳 Ningbo, Zhejiang, China