The Education University of Hong Kong
Hong Kong
NCT Number: NCT07654088
Difficulty swallowing (called dysphagia) is common in older adults and can make eating and drinking unsafe. It may lead to serious problems such as choking, lung infections, poor nutrition, and reduced quality of life. One common way to reduce these risks is to modify food and drink textures (for example, making foods softer or liquids thicker). However, people often find it difficult to prepare food at the correct texture level in everyday life, especially at home, which may reduce the effectiveness of this approach.
This study aims to test whether a smartphone application powered by artificial intelligence (AI) can help older adults with swallowing difficulties eat more safely. The app allows users (or their caregivers) to take a photo of food or drinks, and the app then estimates the texture level and provides guidance to help ensure it is safe to swallow. It also gives simple prompts to double-check food texture when needed.
In this clinical trial, community-dwelling adults aged 60 years or above with swallowing difficulties will be randomly assigned to one of two groups. One group will receive usual care, which includes education about safe swallowing and written instructions on appropriate food textures. The other group will receive the same usual care plus access to the AI-enabled mobile app for 16 weeks. Participants will continue their daily eating routines at home.
The main question this study is trying to answer is: Does using the AI-enabled mobile app improve how often people eat foods that match their recommended safe texture level compared with usual care alone?
The study will also examine whether the app helps reduce swallowing-related problems (such as choking), improves quality of life, and supports better overall eating ability. In addition, the study will evaluate how easy the app is to use and whether it places any burden on users.
Hypothesis: The researchers hypothesize that participants who use the AI-enabled app, in addition to usual care, will more consistently follow recommended food texture guidelines and experience safer eating compared with those who receive usual care alone.
Trial opening soon.
Get Notified60 year and older
All sexes
Interventional
Not applicable
Hong Kong
Dysphagia (swallowing impairment) is a highly prevalent condition in older adults and is associated with increased risks of aspiration, malnutrition, dehydration, and reduced quality of life. While the International Dysphagia Diet Standardization Initiative (IDDSI) framework provides standardized terminology and practical methods for modifying food and liquid textures, ensuring accurate and consistent adherence to prescribed texture levels remains challenging in community settings. In particular, adherence is often limited by the lack of real-time feedback, variable caregiver skills, and difficulties in verifying food texture during routine meal preparation.
This study evaluates a novel, implementation-oriented digital health intervention designed to address these barriers. The intervention is an AI-enabled mobile application that supports real-time classification of food and liquid textures using smartphone-based image capture. The application incorporates a safety-first decision logic, providing conservative classification outputs alongside prompts encouraging users to verify textures using established IDDSI field tests (e.g., flow test, fork pressure test) when classification uncertainty is detected. The system is designed to function within everyday meal preparation workflows, thereby targeting behavioral adherence at the point of consumption rather than relying solely on retrospective education.
The trial adopts a pragmatic, community-based randomized controlled design to assess real-world effectiveness under typical home-use conditions. The intervention is delivered over a defined period of active use, during which participants and/or caregivers may engage with the application during meal preparation, food purchase, or consumption. The application records usage metrics (e.g., frequency of image captures, classification outputs, and uncertainty prompts), enabling evaluation of engagement and fidelity. The intervention is supported by structured onboarding and ongoing technical support to ensure usability among older adults and their caregivers.
The comparator reflects current standard practice in community dysphagia management and allows evaluation of the incremental benefit of digital decision support beyond education alone. The study is designed under a superiority framework to determine whether access to the AI-enabled tool results in meaningful improvements in behavioral adherence, which is considered the proximal mechanism linking dietary modification to downstream clinical outcomes. By focusing on adherence as the primary target, the study aligns with an implementation science perspective, recognizing that efficacy of dietary recommendations depends on their consistent and correct application in daily life.
In addition to assessing behavioral outcomes, the trial incorporates a multidimensional evaluation framework spanning symptom burden, functional oral intake, health-related quality of life, and safety events. These domains provide a comprehensive understanding of both intended benefits and potential unintended consequences, including risks related to misclassification, over-reliance on automated guidance, or increased user burden. A subsample will undergo instrumental swallowing assessments to explore potential changes in swallowing physiology associated with improved adherence, thereby linking behavioral and mechanistic outcomes.
The study also integrates human-technology interaction considerations, including usability and perceived workload, to evaluate implementation feasibility and scalability. These measures are important for determining whether the intervention can be sustainably adopted in routine practice, particularly among older populations with varying levels of digital literacy.
From an analytical perspective, the trial is designed to estimate real-world effectiveness using an intention-to-treat framework, capturing the impact of offering the intervention under typical conditions rather than ideal adherence scenarios. Exploratory analyses will examine associations between engagement metrics and clinical outcomes, as well as potential effect modifiers such as baseline functional status, cognitive factors, and living arrangements.
This research addresses a critical gap in dysphagia care by evaluating a scalable, technology-assisted approach that operationalizes standardized dietary guidelines in real-world settings. It also contributes to the emerging field of AI in healthcare by providing rigorous evidence from a randomized controlled trial conducted outside of highly controlled clinical environments. The findings are expected to inform both clinical practice and public health strategies aimed at improving safe eating behaviors among community-dwelling older adults with dysphagia.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A smartphone-based application that uses artificial intelligence to classify food and liquid textures from images captured by the user. The application provides real-time guidance aligned with standardized dysphagia diet levels and delivers safety-focused prompts to verify texture using simple methods when needed. The tool is designed to support safe meal preparation and improve adherence to prescribed texture-modified diets in daily home settings. Participants receive onboarding and use the application during meals throughout the intervention period.
A structured education session providing guidance on safe swallowing practices and preparation of texture-modified foods and liquids. Participants receive printed educational materials describing appropriate food textures and simple methods for checking consistency. This reflects usual care in community dysphagia management and does not include digital or automated decision support.
Time frame: Week 16
The participant-level proportion of meals that correctly match the prescribed food and liquid texture level, based on standardized dysphagia diet guidelines, during a defined assessment period. In the intervention group, classification is supported by the mobile application and verification procedures; in the control group, adherence is determined using structured dietary logs with verification.
Measure Type / Units: Proportion (0 to 1, or percentage 0-100%) Interpretation: Higher values indicate better adherence to prescribed diet texture
Time frame: Baseline, Week 16, Week 24
Swallowing-related quality of life measured using the Swallowing Quality of Life Questionnaire (SWAL-QOL). Domains include physical, emotional, and social aspects of eating and drinking.
Scale Range: 0 to 100 Interpretation: Higher scores indicate better quality of life
Time frame: Baseline, Week 16, Week 24
Functional oral intake will be assessed using the Functional Oral Intake Scale (FOIS), a 7-level ordinal scale. Change in the level of oral intake, reflecting the degree to which participants can consume food and liquids safely and independently.
Scale Range: 1 to 7 Interpretation: Higher levels indicate better oral intake and less reliance on modified diets or non-oral feeding
Time frame: Baseline to Week 16; Week 16 to Week 24
Incidence of swallowing-related safety events, including choking, near-choking episodes, emergency department visits, and hospitalizations associated with swallowing difficulties.
Time frame: Week 16
Usability of the mobile application will be assessed using the mHealth App Usability Questionnaire (MAUQ). User-reported usability of the mobile application, including ease of use, usefulness, and satisfaction, will be assessed.
Scale Range: Typically 1 to 7 per item (mean total score reported) Interpretation: Higher scores indicate better usability
Time frame: Week 16
Perceived workload associated with app use will be assessed using the NASA Task Load Index (NASA-TLX). Participant-reported mental and physical workload associated with using the mobile application during daily activities will be measured.
Scale Range: 0 to 100 Interpretation: Higher scores indicate greater perceived workload
Time frame: Baseline, Week 16
Swallowing safety and efficiency will be assessed using the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale during instrumental evaluation.
Scale Range: 0 to 4 Interpretation: Higher scores indicate more severe swallowing impairment
Time frame: During the intervention period (Weeks 1-16)
Engagement with the application will be measured by system-generated logs, including participant interaction with the mobile application, frequency of use, number of food scans performed, and response to system prompts.
Measure Type / Units: Count (number of scans per participant) Interpretation: Higher values indicate greater engagement
Time frame: Weeks 1-16
Frequency of responses to application-generated prompts for texture verification will be recorded.
Measure Type / Units: Count and proportion Interpretation: Higher values indicate greater interaction with system guidance
Time frame: Week 8, Week 24
Changes in dietary adherence patterns at intermediate and follow-up time points will be measured to explore sustainability of behavior change. Proportion of meals adhering to prescribed IDDSI level at additional time points will be measured. All meals in the whole week 8 and week 24 will be included in the measurement.
Measure Type / Units: Proportion (0-1 or 0-100%) Interpretation: Higher values indicate better adherence
Contact information is provided by the study sponsor or research team.
KAM Chi Shan Anna
Other
Efficacy of an AI-enabled Mobile Application for Safe Eating in Community-dwelling Older Adults With Dysphagia: a Randomized Controlled Trial
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