Plain English Summary
Background and study aims
There is a great need for new dietary assessment methods that not only provide valid data, but also suit the lifestyles of different types of users. In mHealth app development, prototypes commonly evolve from concept in more than one design variant. The usability of these design variants are rarely subjected to systematic evaluation, and lack comparative evidence from user interaction. The aim of this study is to evaluate and compare the effectiveness of two app designs.
Who can participate?
University students aged over 18 recruited from Chang Gung University (18-29 years old), and older adults recruited among volunteers from Chang Gung Memorial Hospital (55-73 years old)
What does the study involve?
Participants are randomly allocated to use of one two application prototypes. The first application is called self-chosen tab (SCT), and allows users to choose and click each food ingredient to synthesize a food. The second application is called autonomous exhaustive list (AEL), in which users scroll through and select from a comprehensive list of combined food ingredients. The research assistant demonstrates the use of the application through one meal with four food items to familiarize participants with application operation. After the demonstration, each user is allowed to practice application operation for three minutes to warm up. Each participant is asked to observe two actual meals and to record each item in one prototype. The meals are prepared with real food in appropriate portions, and presented consistently on a plate throughout the experiment. Each participant completes the task within 30 minutes. Application usability is assessed in terms of accuracy and response time in the task of reporting the food items. Participant’s time and input of the buttons in each app is automatically recorded by the prototype.
What are the possible benefits and risks of participating?
There are no risks of taking part in the study.
Where is the study run from?
Chang Gung University (Taiwan)
When is the study starting and how long is it expected to run for?
June 2014 to January 2015
Who is funding the study?
1. Ministry of Science and Technology (Taiwan)
2. Research Fund of Chang Gung Memorial Hospital and Chang Gung University (Taiwan)
Who is the main contact?
1. Dr Ying-Chieh Liu
2. Dr Sherry Yueh-Hsia Chiu
Trial website
Contact information
Type
Public
Primary contact
Dr Sherry Yueh-Hsia Chiu
ORCID ID
http://orcid.org/0000-0002-7207-7088
Contact details
Chang Gung University
No. 259
Wen-Hwa 1st Road
333 Kwei-Shan
Tao-Yuan
333
Taiwan
Type
Public
Additional contact
Dr Ying-Chieh Liu
ORCID ID
http://orcid.org/0000-0003-1876-7632
Contact details
Chang Gung University
No. 259
Wen-Hwa 1st Road
333 Kwei-Shan
Tao-Yuan
333
Taiwan
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
103-2745B
Study information
Scientific title
Evaluating mobile prototypes utilization of individual meal recording using a randomised trial
Acronym
Study hypothesis
The aim of this study is to assess the accuracy and efficiency of the two prototypes for dietary recording utilization, including innovative designs of SCT (self-chosen tab) and AEL (autonomous exhaustive list) for individual dietary intakes.
Ethics approval
Ethics Committee of Chang Gung Memorial Hospital, 23/06/2014, ref: 103-2745B
Study design
Randomised parallel trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Schools
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Nutrition
Intervention
A parallel two-group randomized controlled trial (RCT) was designed to evaluate and compare the effectiveness of two app designs to help users select a wide variety of food alternatives. Two prototypes were implemented in the Android operating system for use in mobile devices. The first application is called self-chosen tab (SCT), and allows users to choose and click each food ingredient to synthesize a food. The second application is called autonomous exhaustive list (AEL), in which users scroll through and select from a comprehensive list of combined food ingredients. Participants were recruited through local hospitals and colleges. Baseline data and informed consent were acquired following online registration. The assessment was performed by a research assistant who began the process by administering a basic background questionnaire. The research assistant then demonstrated the use of both applications through one meal with four food items to familiarize participants with application operation. Participants were given three minutes to complete each task. Having completed the first meal, the participant continued to label the second meal without taking a rest. Recruitment and implementation were performed based on the order of randomization lists with a 1:1 ratio. Individual appointments were then made for evaluation.
Intervention type
Device
Phase
Drug names
Primary outcome measure
Application usability assessed in terms of accuracy and response time in the task of reporting the food items:
1. Accuracy was defined as the number of correct counts divided by the overall counts. “Correct” was defined as the subject selecting the correct main food ingredient(s) button in the app as well as the correct food attribute(s) button for each of the 12 items, given unlimited switching among food groups and/or subgroups
2. Response time was recorded in milliseconds in terms of the time elapsed from a user’s selection (clicking) at a certain main food ingredient button to complete in food attribute(s) selection
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
20/06/2014
Overall trial end date
31/01/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. University students aged over 18 recruited from Chang Gung University (18-29 years old)
2. 35 older adults recruited among volunteers from Chang Gung Memorial Hospital (55-73 years old)
Participant type
Healthy volunteer
Age group
Mixed
Gender
Both
Target number of participants
The minimal sample size with 50 subjects was required for each arm
Participant exclusion criteria
Those who could not use smartphone or could not communicate with others
Recruitment start date
30/09/2014
Recruitment end date
10/01/2015
Locations
Countries of recruitment
Taiwan
Trial participating centre
Chang Gung University
No. 259, Wen-Hwa 1st Road, 333 Kwei-Shan
Tao-Yuan
333
Taiwan
Trial participating centre
Chang Gung Memorial Hospital, LinKuo, Taiwan
No.5, Fuxing St., Kwei-Shan
Tao-yuan
333
Taiwan
Sponsor information
Organisation
Chang Gung University
Sponsor details
No. 259
Wen-Hwa 1st Road
333 Kwei-Shan
Tao-Yuan
333
Taiwan
Sponsor type
University/education
Website
Organisation
Chang Gung Memorial Hospital
Sponsor details
No.5
Fuxing Street
Kwei-Shan
Tao-yuan City 333
Tao-yuan
333
Taiwan
+886 (0)3 3281200
ycl30@mail.cgu.edu.tw
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Research Fund of Chang Gung Memorial Hospital and Chang Gung University (BMRPB81; BMRPD67)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ministry of Science and Technology, Taiwan (NSC-105-2221-E-182-044; NSC-104-2221-E-182-049)
Alternative name(s)
Ministry of Science and Technology of Taiwan, MOST
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Taiwan
Results and Publications
Publication and dissemination plan
The trialists intend to publish this study on 30/05/2018.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Sherry Yueh-Hsia Chiu. This should follow the mechanism governed by the ethical committee agreement.
Intention to publish date
30/05/2018
Participant level data
Available on request
Basic results (scientific)
Publication list
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30767906