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Usability Evaluation of Gen AI-based Nutrition Chatbot for Pregnant Women

ConditionsDiabetes, GestationalPre-eclampsiaAI Chatbot for Prenatal Nutrition Guidance
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHong Kong Metropolitan University

About this trial

Background: Pregnancy imposes significant physical demands, with complications like gestational diabetes (GDM) and pre-eclampsia posing serious risks. Nutrition is crucial for mitigation, but accessing reliable guidance remains challenging. This study evaluates the feasibility of an AI chatbot providing nutritional guidance for managing these conditions.

Methods: In a quasi-experimental design, 100 pregnant women will self-select into either the intervention group (n=50, using an AI chatbot) or control group (n=50, receiving standard care). The primary outcome is usability measured by the System Usability Scale (SUS) at 12 weeks, with an expected mean difference of ≥13 points. Secondary outcomes include technology acceptance (Technology Acceptance Model), user engagement, information accuracy, and changes in dietary knowledge/behaviors. Quantitative data will be analyzed using intention-to-treat and t-tests. Semi-structured interviews with 20 participants will explore user experiences through thematic analysis.

Expected Results: The AI chatbot is anticipated to demonstrate superior usability and high user acceptance (TAM \>5.0/7), with improvements in dietary knowledge and behavior. Qualitative findings will provide insights into benefits, barriers, and engagement factors.

Conclusion: This study will establish an evidence base on AI chatbot feasibility and acceptance for prenatal nutrition, informing tool optimization and future large-scale trials.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant women aged 18 years or older

Able to provide informed consent in the study language

Own a smartphone with internet access and the WeChat application

Disqualifiers

Current enrollment in other nutrition intervention studies

Severe mental health conditions that may impair technology use or ability to provide informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • a culturally tailored nutrition AI chatbot for pregnant women

    Behavioral

    A culturally tailored nutrition AI chatbot for pregnant women , and the AI chatbot support will be available 24/7

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: The intervention groupExperimental treatment 1 intervention
Group B: The control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

System Usability Scale (SUS)

Usability will be assessed using the System Usability Scale (SUS), a 10-item questionnaire with five-point Likert responses. SUS yields a total score ranging from 0 to 100, with higher scores indicating better perceived usability. Scores will be compared between groups at 12 weeks.

Time frame
12weeks

Secondary outcomes

1

Mean Score on the Technology Acceptance Model (TAM) Questionnaire

Technology acceptance will be assessed using the Technology Acceptance Model (TAM) questionnaire. This 12-item instrument measures two domains: perceived usefulness (6 items) and perceived ease of use (6 items). Each item is rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Domain scores are calculated as the mean of items within each domain, with higher scores indicating greater perceived usefulness or ease of use.

Time frame
12 weeks
2

Proportion of Participants Achieving Adequate Engagement Adherence

Engagement adherence will be measured using application usage logs. Adequate adherence is defined as using the platform at least 3 days per week for at least 10 out of the 12-week intervention period. The proportion of participants meeting this threshold will be reported.

Time frame
12 weeks
3

Mean Number of Platform Logins per Week

Engagement intensity will be measured using application usage logs. The average number of logins per week over the 12-week intervention period will be calculated for each participant and reported as a group mean.

Time frame
12 weeks
4

Mean Number of Queries Submitted per Participant

Engagement intensity will also be assessed by the total number of queries (questions or requests) submitted by each participant to the platform over the 12-week intervention period, reported as a group mean.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hong Kong Metropolitan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: