Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07458997

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

Objectives: This study primarily aims to evaluate the usability of a nutrition AI chatbot for pregnant women by comparing System Usability Scale (SUS) scores between intervention and control groups. Secondary objectives include assessing technology acceptance (Technology Acceptance Model), engagement patterns, information quality (accuracy, comprehensibility, consistency), and changes in nutritional knowledge.

Design: A quasi-experimental design with two parallel groups (n=50 each) will be employed. Using self-selection, participants will choose to enroll in the intervention group (access to an AI chatbot plus routine care) or the control group (access to a standardized WeChat information service plus routine care). Routine care for all participants includes standard prenatal clinic visits and printed nutritional materials.

The WeChat service for the control group will be operated by a trained research assistant using a pre-defined script during two scheduled windows daily, providing information quoted from the official nutritional leaflets. This isolates the mode of information delivery (AI versus human-facilitated messaging) as the primary variable.

Participants: Inclusion criteria: pregnant women aged ≥18 years, able to consent, owning a smartphone with internet access. Exclusion criteria: enrollment in other nutrition interventions or severe mental health conditions impairing technology use. A purposive subsample of 20 participants (10 per group) will complete qualitative interviews.

Sample Size: Based on an expected mean SUS score of 78 (SD=12) in the intervention group and 65 (SD=15) in the control group (Cohen's d=0.95), 23 participants per group are required for 90% power at alpha=0.05. Accounting for 50% attrition, 50 participants per group will be recruited. Propensity score matching will be applied to reduce selection bias using variables including age, gestational age, parity, education, and baseline technology use.

Measurements: The primary outcome, usability, will be measured using the System Usability Scale (SUS) and the Chatbot Usability Questionnaire (CUQ) at 12 weeks. Technology acceptance will be assessed using the Technology Acceptance Model (TAM). Nutritional knowledge will be evaluated at baseline and 12 weeks using a 15-item questionnaire and the FIGO Nutrition Checklist. Information accuracy and consistency will be assessed by an expert panel rating 150 chatbot responses and repeated submission of 20 test questions. Engagement will be analyzed via application usage logs measuring adherence, intensity, and persistence. Semi-structured interviews will explore user experiences in depth.

Data Analysis: Quantitative data will be analyzed using intention-to-treat principles. Primary analysis will compare mean SUS scores between groups using independent samples t-tests, with effect sizes calculated as Cohen's d. Secondary outcomes will be analyzed using similar approaches, with chi-square tests for proportions and linear mixed models for nutritional knowledge change scores. Missing data will be addressed through multiple imputation. Qualitative interview transcripts will be analyzed using thematic analysis with dual independent coding.

Study Timeline: Participants will be enrolled over a 6-month period, with each participant completing a 12-week intervention and follow-up period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Current enrollment in other nutrition intervention studies
  • Severe mental health conditions that may impair technology use or ability to provide informed consent

Treatment and study plan

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

Primary outcomes

  1. System Usability Scale (SUS)

    Time frame: 12weeks

    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.

Secondary outcomes

  1. Mean Score on the Technology Acceptance Model (TAM) Questionnaire

    Time frame: 12 weeks

    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.

  2. Proportion of Participants Achieving Adequate Engagement Adherence

    Time frame: 12 weeks

    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.

  3. Mean Number of Platform Logins per Week

    Time frame: 12 weeks

    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.

  4. Mean Number of Queries Submitted per Participant

    Time frame: 12 weeks

    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.

  5. Proportion of Chatbot Responses Rated as Accurate by Clinical Expert Panel

    Time frame: 12 weeks

    A panel of clinical experts will rate a sample of 150 chatbot responses for accuracy. Responses will be rated as accurate or inaccurate based on alignment with current clinical guidelines. The proportion of responses rated as accurate will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Bronya Luk, DHSc

CONTACT

[email protected]

+852 39708758 ext. +852 39708758

Sponsors and collaborators

Lead sponsor

Hong Kong Metropolitan University

Other

Registry information

Official study title

Usability Evaluation of Gen AI-based Nutrition Chatbot for Pregnant Women: A Pilot Quasi-experimental Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.