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

NCT07582068 | Not Yet Recruiting

• 1 other identifier: 20260506
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mobile Health Apps; Lifestyle Intervention; Prevention; Multi-component Based Behavioral Intervention

Keywords

Prevention; Gestational diabetes mellitus; Mobile health; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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

  24 Weeks

Secondary Outcomes (1)

• Adverse pregnancy and adverse birth outcomes

  42 days postpartum

Study Arms (2)

Intervention Group: AI-Enabled Mobile Health Management App Plus Routine Antenatal Care

EXPERIMENTAL

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

Control Group: Routine Antenatal Care Alone

NO 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.

Interventions

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.

Intervention Group: AI-Enabled Mobile Health Management App Plus Routine Antenatal Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fangbiao Tao: lead

Study Sites (1)

Anhui Medical University

Hefei, Anhui, 231200, China

Location

Related Publications (1)

• Duan B, Liu L, Ma C, Liu Z, Gou B, Liu W. Effects of mobile health management model on the prevention of gestational diabetes mellitus in pregnant women at risk of gestational diabetes: A randomized controlled trial. Int J Nurs Stud. 2026 Jan;173:105252. doi: 10.1016/j.ijnurstu.2025.105252. Epub 2025 Oct 16.

  PMID: 41135300 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Fangbiao Tao, PhD

CONTACT

13856986775; taofangbiao@126.com

Tiemei Li, PhD

CONTACT

13541602092; tiemei.li@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): August 10, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)