Effects of an AI-driven Mobile Health Management Intervention to Prevent Gestational Diabetes Mellitus in High-risk Pregnant Women: A Pragmatic Randomized Controlled Trial
Sponsor: Fangbiao Tao
Trial Details
| Condition | Mobile Health Apps, Lifestyle Intervention, Prevention, Multi-component Based Behavioral Intervention |
| Intervention | Multi-component lifestyle intervention |
| Phase | NA |
| Status | Not_yet_recruiting |
| Participants | 400 |
| Est. Completion | 31 Dec 2027 |
| Last Updated | 12 May 2026 |
Primary Outcome
The prevalence of gestational diabetes mellitus
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: * Pregnant women aged ≥18 years * Singleton pregnancy * Gestational age \<13+6 weeks at enrollment * At least one of the following GDM risk factors: 1. Age ≥35 years 2. Pre-pregnancy BMI ≥24 kg/m² 3. Family history of diabetes (first-degree relatives) 4. Previous history of gestational diabetes mellitus 5. Prior delivery of a macrosomic infant (birth weight ≥4000 g) * Polycystic ovary syndrome * Use of an Android smartphone * No severe heart, liver, or kidney diseases * Voluntary participation and signed informed consent Exclusion Criteria: * Pre-pregnancy diagnosis of diabetes mellitus (type 1 or type 2) * Severe mental illness * Confirmed severe pregnancy complications (e.g., preeclampsia, placental abruption, etc.) * Inability to complete questionnaires or intervention * Participation in other interventional studies
Trial Sites
Countries
This content is for educational purposes for healthcare professionals only and does not constitute clinical advice. Clinical decisions should be based on individual patient assessment, current guidelines, and appropriate specialist consultation. Editorial Standards · Privacy Policy · Terms of Service