Mobile Internet Healthcare and Three Disciplines Co-management Intervention for Overweight/Obese Prediabetic Patients

NCT06147752 | Unknown

• 1 other identifier: 3502Z20224ZD1027
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Overweight/Obesity; Prediabetes; Weight Management

Outcome Measures

Primary Outcomes (3)

• Change of weight

  Whether there was a significant difference in weight change between the intervention and control groups

  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

  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

  After 6 months of intervention, the change of HOMA-IR was compared between the two groups

Secondary Outcomes (4)

• Change of BMI

  After 6 months of intervention, the change of BMI was compared between the two groups

• Change of waistline

  After 6 months of intervention, the change of waistline was compared between the two groups

• Change of serum lipid level

  After 6 months of intervention, the change of serum lipid level was compared between the two groups

• Change of hepatic steatosis value

  After 6 months of intervention, the change of hepatic steatosis value was compared between the two groups

Study Arms (2)

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.

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.

Behavioral: mobile internet healthcare and "co-management of three disciplines"

Interventions

mobile internet healthcare and "co-management of three disciplines" BEHAVIORAL

"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.

Mobile internet healthcare treatment and "three disciplines co-management"; Traditional diagnosis and treatment mode

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ①18 years≤ Age\<70 years
• mmol/L≤ fasting blood glucose \<6.9mmol/L
• mmol/L≤2h blood glucose \<11.0mmol/L;
• Kg/m2≤BMI≤45Kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Prediabetic State

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• xin zheng

  The First Affiliated Hospital of Xiamen University

  STUDY DIRECTOR

Central Study Contacts

xin zheng

CONTACT

18705929102; zx2001528@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The First Affiliated Hospital of Xiamen University

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 28, 2023
• Study Start: March 28, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

CN (1)