Mobile healthcare intervention for overweight and prediabetic patients
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
This study is testing a mobile health program to help overweight and prediabetic patients lose weight and improve their eating habits with support from dietitians and weight managers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Xiamen University Academic / other |
| Locations | 1 site (Xiamen, Fujian) |
| Trial ID | NCT06147752 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on managing overweight and obese patients who are prediabetic through a mobile internet healthcare platform and a co-management approach involving three disciplines. The study aims to reverse prediabetes by implementing lifestyle changes, particularly weight loss, which is crucial for preventing diabetes and its complications. Participants will receive personalized guidance from dietitians and weight managers to help them adopt healthier eating habits and manage their weight effectively. The study will enroll 100 patients who meet specific eligibility criteria and will assess the effectiveness of this intervention over time.
Who should consider this trial
Good fit: Ideal candidates for this study are overweight or obese individuals aged 18 to 70 with prediabetes.
Not a fit: Patients who have been diagnosed with diabetes or have recently used diabetes medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the risk of developing diabetes in overweight and prediabetic patients.
How similar studies have performed: Other studies have shown success with lifestyle interventions for weight management in prediabetic populations, indicating that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
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
Exclusion Criteria:
* 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
Where this trial is running
Xiamen, Fujian
- The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Recruiting)
Study contacts
- Study coordinator: xin zheng
- Email: zx2001528@163.com
- Phone: 18705929102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.