An interventional study of Multi-component lifestyle intervention in Mobile Health Apps, Lifestyle Intervention and Prevention, sponsored by Fangbiao Tao. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Fangbiao Tao · Not applicable, Interventional, and Prevention
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
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's planned enrollment of 400 is above the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Fangbiao Tao is the lead sponsor of 10 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
At least one of the following GDM risk factors:
Exclusion Criteria:
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.
Behavioral: Multi-component lifestyle intervention
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.
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.
The prevalence of gestational diabetes mellitus
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
Time frame: 24 Weeks
Adverse pregnancy and adverse birth outcomes
Maternal pregnancy outcomes and general neonatal outcomes were collected via self administered scales
Time frame: 42 days postpartum
Plan to share: No
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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