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

6 mei 2026 bijgewerkt door: Fangbiao Tao

Effects of an AI-driven Mobile Health Management Intervention to Prevent Gestational Diabetes Mellitus in High-risk Pregnant Women: A Pragmatic Randomized Controlled Trial

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.

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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

400

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Intervention Group: AI-Enabled Mobile Health Management App Plus Routine Antenatal Care
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.
Gedragsmatig: Multi-component lifestyle intervention
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-ins (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.
Geen tussenkomst: Control Group: Routine Antenatal Care Alone
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The prevalence of gestational diabetes mellitus
Tijdsspanne: 24 Weeks
The diagnostic criteria for Potential simultaneous submissions were found in: International Journal of Nursing Sciences will follow the International Association of Diabetes and Pregnancy Study Groups (IADPSG) guidelines. Glucose tolerance tests will be conducted at 24 weeks of gestation (calculated from the last menstrual period). According to the diagnostic criteria, reference values for fasting, one-hour, and two-hour blood glucose levels are 5.1 mmol/L, 10.0 mmol/L, and 8.5 mmol/L, respectively. A diagnosis of gestational diabetes mellitus is confirmed if any of these values meet or exceed the specified thresholds
24 Weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adverse pregnancy and adverse birth outcomes
Tijdsspanne: 42 days postpartum
Maternal pregnancy outcomes and general neonatal outcomes were collected via self administered scales
42 days postpartum

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Fangbiao Tao

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

10 augustus 2026

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

6 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 mei 2026

Eerst geplaatst (Werkelijk)

12 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

6 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 20260506

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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