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Effectiveness of an AI-Enabled Mobile Intervention on Lifestyle Behaviors and Maternal-Infant Health

A legfontosabb adatok

Ki végzi
Fangbiao Tao
Hol
Kína1 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Toborzás még nem indult
Résztvevők
400 fő, tervezett
Kezdés
2026. aug. 10.
Várható befejezés
2027. dec. 31.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport nem kap vizsgálati kezelést, összehasonlításként.
A vizsgált kezelések
  • Multi-component lifestyle intervention
A regiszteradat frissítve
2026. május 12.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for women in early pregnancy who have a higher chance of getting diabetes during pregnancy. It tests whether an AI phone app can help prevent this diabetes.

Életkor
18 years and older
Nem
Women only
A betegség stádiuma
Pregnant with one baby, less than 13+6 weeks into the pregnancy when joining. At least one risk factor for diabetes in pregnancy: age ≥35 years, pre-pregnancy BMI ≥24 kg/m², diabetes in a parent, sibling or child, diabetes in an earlier pregnancy, or an earlier baby weighing ≥4000 g. Polycystic ovary syndrome is also listed.

A részvétel fő kizáró okai

  • Diabetes (type 1 or type 2) found before the pregnancy
  • Severe heart, liver or kidney disease, or severe mental illness
  • Severe pregnancy problems, such as preeclampsia or placental abruption
  • No Android smartphone, or not able to fill in questionnaires or use the program
  • Taking part in another interventional study

Ez a vizsgálat csak várandós résztvevőket keres. A regiszter mondata, amelyen ez alapul: Pregnant women aged ≥18 years

A regiszter feltételei, szó szerint

Mind a 13 feltétel megnézéseKevesebb

Ki vehet részt

  • Pregnant women aged ≥18 years
  • Singleton pregnancy
  • Gestational age <13+6 weeks at enrollment
  • At least one of the following GDM risk factors:; Age ≥35 years; Pre-pregnancy BMI ≥24 kg/m²; Family history of diabetes (first-degree relatives); Previous history of gestational diabetes mellitus; 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

Ki nem vehet részt

  • 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

Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.

Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

The goal of this pragmatic randomized controlled trial is to evaluate the effectiveness of an AI-enabled mobile health management application ("Better Pregnancy" app), grounded in the Theory of Planned Behavior, in preventing gestational diabetes mellitus (GDM) among pregnant women at high risk of GDM, and to assess its impact on maternal and infant health outcomes.

A teljes eredeti leírásKevesebb

Study Population: Eligible participants are pregnant women aged 18-49 years, with a singleton pregnancy, gestational age <12 weeks at enrollment, and at least one GDM risk factor (age ≥35 years, pre-pregnancy BMI ≥24 kg/m², family history of diabetes, previous history of GDM, prior delivery of a macrosomic infant [birth weight ≥4000 g], or polycystic ovary syndrome). Participants must have no heart, liver, or kidney diseases, use an Android smartphone, and provide written informed consent.

The main questions it aims to answer are:

Can the AI-driven mobile lifestyle intervention reduce the incidence of GDM in high-risk pregnant women?

Does the intervention improve lifestyle behaviors (diet, physical activity, sleep) and glycemic control (measured by continuous glucose monitoring) in participants?

What is the adherence, acceptability, and cost-effectiveness of this intervention in real-world clinical settings?

Comparison: Researchers will compare two groups of pregnant women: the intervention group (receiving the AI-enabled "Better Pregnancy" app plus routine antenatal care) and the control group (receiving routine antenatal care alone).

Participants will:

Enroll in the first trimester (<12 weeks of gestation) and complete a baseline lifestyle and health status questionnaire

In the intervention group: watch 7 cognitive-attitudinal videos within the first week, then complete 12 weeks of AI-driven personalized intervention (daily check-ins, receiving tailored recommendations on diet, physical activity, sleep, etc.)

During the intervention period, participants in the intervention group will wear a continuous glucose monitoring device for 7 days to assess the impact of the intervention on glycemic fluctuations

Complete the first follow-up lifestyle and health status assessment after the intervention (approximately in the second trimester)

Undergo an oral glucose tolerance test during the second trimester (24-28 weeks)

Complete the second follow-up lifestyle and health status assessment in the third trimester (≥28 weeks)

Complete the third follow-up lifestyle and health status assessment at 42 days postpartum, along with collection of delivery outcomes and infant health information

A subset of participants may voluntarily provide blood and stool samples for mechanistic studies

A vizsgálat 2 csoportja

  • Intervention Group: AI-Enabled Mobile Health Management App Plus Routine Antenatal CareA vizsgált kezelés

    Participants receive a 12-week AI-powered intervention via the "PregSelfCare" app plus routine antenatal care. The intervention includes: (1) watching 7 theory-based videos and completing an attitude questionnaire in week 1; (2) daily check-in (mood, water, fruit, bowel movements, sunlight, weight) and receiving AI-driven personalized recommendations (diet photo feedback, step goals, sleep advice, emotion-relief videos, supplement reminders) during weeks 1-12, with content dynamically adjusted based on baseline lifestyle assessment and adherence; (3) wearing a continuous glucose monitor for 7 days; (4) completing a satisfaction questionnaire after the intervention (week 12), with a subset invited for semi-structured interviews.

    Kezelés: Multi-component lifestyle intervention

  • Control Group: Routine Antenatal Care AloneNincs vizsgálati kezelés, összehasonlításként

    Participants in the control group receive routine antenatal care and standardized pregnancy health education (including verbal guidance and conventional brochures) provided by their hospitals. They do not have access to the "Better Pregnancy" app and receive no additional mobile health intervention. Data collection, including questionnaires and oral glucose tolerance tests, is completed at the same time points as the intervention group. After study completion, control participants will be offered access to the app.

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Effects of an AI-driven Mobile Health Management Intervention to Prevent Gestational Diabetes Mellitus in High-risk Pregnant Women: A Pragmatic Randomized Controlled Trial
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 15.
A regiszteradat frissítve
2026. május 12.