Gestational Diabetes Mellitus (GDM)RADENCT06999421
The Impact of Robot-assisted Digital Education on Prenatal Women's Health Literacy
A study testing Robot with interactive animations, gesture recognition, and touch/voice-based input and Standard tablet (video playback only). in people with Gestational Diabetes Mellitus (GDM), run by Taipei Medical University at 1 site in Taiwan.
Trial summary
This randomized controlled trial evaluates the effectiveness of a robot-assisted digital education program for pregnant women diagnosed with gestational diabetes mellitus (GDM). The intervention aims to reduce anxiety, improve health literacy, and increase satisfaction and acceptance of digital health technologies. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- What is being tested?
- Robot with interactive animations, gesture recognition, and touch/voice-based input and Standard tablet (video playback only).
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women aged ≥21 years
- Diagnosed with gestational diabetes mellitus (GDM)
- Normal first prenatal ultrasound
- Taiwanese nationality
- Provided informed consent
Who cannot join
- Non-Taiwanese nationality
- Chronic disease history
- Cognitive impairment or psychiatric disorder
- Declined participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Robot-assisted Digital Education on Prenatal Women's Health Literacy: A Randomized Controlled Trial
This randomized controlled trial evaluates the effectiveness of a robot-assisted digital education program for pregnant women diagnosed with gestational diabetes mellitus (GDM). The intervention aims to reduce anxiety, improve health literacy, and increase satisfaction and acceptance of digital health technologies. Participants are randomly assigned to either a robot-assisted education group or a conventional tablet-based video education group. Outcome measures include anxiety scores, health literacy scores, and educational satisfaction.
Read the detailed description
This study implemented a robot-assisted digital education method for teaching about gestational diabetes mellitus (GDM) that was intended to reduce anxiety and encourage healthy behaviors among pregnant women. A randomized controlled trial was conducted to assess the effectiveness of the intervention, where 66 pregnant women from a single hospital were randomly assigned to either the experimental group (n = 32) or the control group (n = 34). The experimental group received health education about GDM using a robot, while the control group received the same health education through video presentations on a tablet. The results showed that the implemented robot-assisted digital education method not only reduced anxiety levels among pregnant women, but also influences their health education satisfaction, health literacy, and acceptance of technology. In the global information age, this study can serve as a reference for educators and researchers at medical institutions interested in tracking long-term health education through technological tools.
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Being tested
- Robot with interactive animations, gesture recognition, and touch/voice-based input, Standard tablet (video playback only).
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot with interactive animations, gesture recognition, and touch/voice-based inputDevice
A humanoid educational robot that provides GDM-related content using animated videos, emotional facial expressions, gesture movements, and voice/touch-based interaction. Designed to increase engagement, reduce anxiety, and improve health literacy among pregnant women.
Standard tablet (video playback only).Device
A standard touchscreen tablet used to deliver pre-recorded educational videos on GDM. This intervention provides passive viewing without any robot interaction or feedback.
| Study group | Role | What they receive |
|---|---|---|
| Robot-Assisted Education Group | Experimental | Participants in this group receive a 30-minute robot-assisted digital health education session about gestational diabetes mellitus (GDM). The robot delivers content using animated videos, emotional facial expressions, gesture recognition, and interactive responses via touch and voice input. Receives: Device: Robot with interactive animations, gesture recognition, and touch/voice-based input |
| Tablet-Based Education Group (Control) | Experimental | Participants in this group receive the same 30-minute health education content about GDM via a standard tablet. The video is identical to that in the experimental group but lacks interactive features such as gesture recognition or robot expressions. Receives: Device: Standard tablet (video playback only). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Level
Anxiety levels were assessed using a Likert-type scale ranging from 1 (no symptoms) to 5 (severe anxiety).
Measured: Immediately post-intervention
Health Literacy
Health literacy, which also used a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree)
Measured: Immediately post-intervention
Secondary outcomes (2)
Health education Satisfaction
Health education satisfaction was using a Likert scale ranging from 1 (very satisfied) to 5 (very dissatisfied)
Measured: Immediately post-intervention
Technology Acceptance
technology acceptance of the pregnant women was measured using another Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree)
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start1 Nov 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
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 Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel group design: one experimental (robot-assisted) and one control (tablet-based video)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999421
- Sponsor's protocol ID
- N202309040
- Other IDs
- N202309040
- Acronym
- RADE
- Status last verified
- May 2025
- First submitted
- 4 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang CL, Xu ZY, Chang CY. The Impact of Robot-Assisted Digital Education on Prenatal Women's Health Literacy: A Randomized Controlled Trial. J Nurs Manag. 2025 Jun 5;2025:8865606. doi: 10.1155/jonm/8865606. eCollection 2025.
PubMed 40510888
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Robot-assisted Digital Education on Prenatal Women's Health Literacy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06999421
- Acronym / sponsor ID
- RADE / N202309040
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 31 May 2025 (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.
This randomized controlled trial evaluates the effectiveness of a robot-assisted digital education program for pregnant women diagnosed with gestational diabetes mellitus (GDM). The intervention aims to reduce anxiety, improve health literacy, and increase satisfaction and acceptance of digital health technologies. Participants are randomly assigned to either a robot-assisted education group or a conventional tablet-based video education group. Outcome measures include anxiety scores, health literacy scores, and educational satisfaction.
Detailed description
This study implemented a robot-assisted digital education method for teaching about gestational diabetes mellitus (GDM) that was intended to reduce anxiety and encourage healthy behaviors among pregnant women. A randomized controlled trial was conducted to assess the effectiveness of the intervention, where 66 pregnant women from a single hospital were randomly assigned to either the experimental group (n = 32) or the control group (n = 34). The experimental group received health education about GDM using a robot, while the control group received the same health education through video presentations on a tablet. The results showed that the implemented robot-assisted digital education method not only reduced anxiety levels among pregnant women, but also influences their health education satisfaction, health literacy, and acceptance of technology. In the global information age, this study can serve as a reference for educators and researchers at medical institutions interested in tracking long-term health education through technological tools.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two-arm parallel group design: one experimental (robot-assisted) and one control (tablet-based video)
| Arm | Type | Receives |
|---|---|---|
| Robot-Assisted Education Group | Experimental | Device: Robot with interactive animations, gesture recognition, and touch/voice-based inputParticipants in this group receive a 30-minute robot-assisted digital health education session about gestational diabetes mellitus (GDM). The robot delivers content using animated videos, emotional facial expressions, gesture recognition, and interactive responses via touch and voice input. |
| Tablet-Based Education Group (Control) | Experimental | Device: Standard tablet (video playback only).Participants in this group receive the same 30-minute health education content about GDM via a standard tablet. The video is identical to that in the experimental group but lacks interactive features such as gesture recognition or robot expressions. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant women aged ≥21 years
- Diagnosed with gestational diabetes mellitus (GDM)
- Normal first prenatal ultrasound
- Taiwanese nationality
- Provided informed consent
Key exclusion criteria (4 listed)
- Non-Taiwanese nationality
- Chronic disease history
- Cognitive impairment or psychiatric disorder
- Declined participation
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 |
|---|---|---|
| Robot with interactive animations, gesture recognition, and touch/voice-based inputA humanoid educational robot that provides GDM-related content using animated videos, emotional facial expressions, gesture movements, and voice/touch-based interaction. Designed to increase engagement, reduce anxiety, and improve health literacy among pregnant women. | Device | Robot-Assisted Education Group |
| Standard tablet (video playback only).A standard touchscreen tablet used to deliver pre-recorded educational videos on GDM. This intervention provides passive viewing without any robot interaction or feedback. | Device | Tablet-Based Education Group (Control) |
Primary outcome
Anxiety Level
Time frame: Immediately post-intervention
Anxiety levels were assessed using a Likert-type scale ranging from 1 (no symptoms) to 5 (severe anxiety).
Health Literacy
Time frame: Immediately post-intervention
Health literacy, which also used a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree)
2 secondary outcomes
Health education Satisfaction
Time frame: Immediately post-intervention
Technology Acceptance
Time frame: Immediately post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Derived from this study: PubMed 40510888Yang CL, Xu ZY, Chang CY. The Impact of Robot-Assisted Digital Education on Prenatal Women's Health Literacy: A Randomized Controlled Trial. J Nurs Manag. 2025 Jun 5;2025:8865606. doi: 10.1155/jonm/8865606. eCollection 2025.
- https://orcid.org/0000-0002-3146-2270Link provided by the sponsor.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot with interactive animations, gesture recognition, and touch/voice-based input and Standard tablet (video playback only). in people with Gestational Diabetes Mellitus (GDM), run by Taipei Medical University at 1 site in Taiwan.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 31 May 2025. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Level (time frame: Immediately post-intervention). The study lists 2 primary outcomes in all. 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 NCT06999421, 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 31 May 2025.