Not_yet_recruitingNANCT07582068

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

ConditionMobile Health Apps, Lifestyle Intervention, Prevention, Multi-component Based Behavioral Intervention
InterventionMulti-component lifestyle intervention
PhaseNA
StatusNot_yet_recruiting
Participants400
Est. Completion31 Dec 2027
Last Updated12 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

China
View Registry Entry

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