Mobile Health AppsNCT07582068
Effectiveness of an AI-Enabled Mobile Intervention on Lifestyle Behaviors and Maternal-Infant Health
A study testing Multi-component lifestyle intervention in people with Mobile Health Apps and Lifestyle Intervention, run by Fangbiao Tao at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mobile Health Apps, Lifestyle Intervention, Prevention
- What is being tested?
- Multi-component lifestyle intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Anhui Medical University
Hefei, Anhui, 231200
Tiemei Li, PhD, 13541602092, tiemei.li@foxmail.com
tiemei.li2022@gmail.com
About this study
Official 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
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.
Read more
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
- Being tested
- Multi-component lifestyle intervention
- Keywords
- Prevention, Gestational diabetes mellitus, Mobile health, Randomized controlled trial
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-component lifestyle interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 Weeks
Secondary outcomes (1)
Adverse pregnancy and adverse birth outcomes
Maternal pregnancy outcomes and general neonatal outcomes were collected via self administered scales
Measured: 42 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start10 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mobile Health AppsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fangbiao Tao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fangbiao Tao, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582068
- Sponsor's protocol ID
- 20260506
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41135300
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07582068
- Acronym / sponsor ID
- 20260506
- Conditions
- Mobile Health Apps, Lifestyle Intervention, Prevention, Multi-component Based Behavioral Intervention
- Keywords
- Prevention, Gestational diabetes mellitus, Mobile health, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fangbiao TaoUniversity, hospital or other
- Study start
- 10 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: AI-Enabled Mobile Health Management App Plus Routine Antenatal Care | Experimental | Behavioral: Multi-component lifestyle interventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Pregnant women aged ≥18 years
- Singleton pregnancy
- Gestational age <13+6 weeks at enrollment
- At least one of the following GDM risk factors:
- Polycystic ovary syndrome
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-component lifestyle interventionParticipants 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. | Behavioural | Intervention Group: AI-Enabled Mobile Health Management App Plus Routine Antenatal Care |
Primary outcome
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
1 secondary outcome
Adverse pregnancy and adverse birth outcomes
Time frame: 42 days postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Background: PubMed 41135300Duan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-component lifestyle intervention in people with Mobile Health Apps and Lifestyle Intervention, run by Fangbiao Tao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fangbiao Tao, PhD (13856986775, taofangbiao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of gestational diabetes mellitus (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07582068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.