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NCT Number: NCT07582068

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

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

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Key information

Conditions

Mobile Health Apps Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Lifestyle Intervention Metabolic Diseases Multi-component Based Behavioral Intervention Nutritional and Metabolic Diseases Pregnancy Complications Prevention Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

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

Treatment and study plan

Multi-component lifestyle intervention

Behavioral

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.

Primary outcomes

  1. The prevalence of gestational diabetes mellitus

    Time frame: 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

Secondary outcomes

  1. Adverse pregnancy and adverse birth outcomes

    Time frame: 42 days postpartum

    Maternal pregnancy outcomes and general neonatal outcomes were collected via self administered scales

Study contacts

Contact information is provided by the study sponsor or research team.

Fangbiao Tao, PhD

CONTACT

[email protected]

13856986775

Tiemei Li, PhD

CONTACT

[email protected]

13541602092

Sponsors and collaborators

Lead sponsor

Fangbiao Tao

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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