Evaluating mobile prototypes utilization of individual meal recording

ISRCTN ISRCTN86142301
DOI https://doi.org/10.1186/ISRCTN86142301
Secondary identifying numbers 103-2745B
Submission date
02/12/2017
Registration date
05/04/2018
Last edited
18/02/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Sherry Yueh-Hsia Chiu
Public

Chang Gung University
No. 259
Wen-Hwa 1st Road
333 Kwei-Shan
Tao-Yuan
333
Taiwan

ORCiD logoORCID ID 0000-0002-7207-7088
Dr Ying-Chieh Liu
Public

Chang Gung University
No. 259
Wen-Hwa 1st Road
333 Kwei-Shan
Tao-Yuan
333
Taiwan

ORCiD logoORCID ID 0000-0003-1876-7632

Study information

Study designRandomised parallel trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)School
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleEvaluating mobile prototypes utilization of individual meal recording using a randomised trial
Study objectivesThe 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(s)Ethics Committee of Chang Gung Memorial Hospital, 23/06/2014, ref: 103-2745B
Health condition(s) or problem(s) studiedNutrition
InterventionA 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 typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureApplication 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 measuresThere are no secondary outcome measures
Overall study start date20/06/2014
Completion date31/01/2015

Eligibility

Participant type(s)Healthy volunteer
Age groupMixed
Lower age limit18 Years
Upper age limit73 Years
SexBoth
Target number of participantsThe minimal sample size with 50 subjects was required for each arm
Key inclusion criteria1. 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)
Key exclusion criteriaThose who could not use smartphone or could not communicate with others
Date of first enrolment30/09/2014
Date of final enrolment10/01/2015

Locations

Countries of recruitment

  • Taiwan

Study participating centres

Chang Gung University
No. 259, Wen-Hwa 1st Road, 333 Kwei-Shan
Tao-Yuan
333
Taiwan
Chang Gung Memorial Hospital, LinKuo, Taiwan
No.5, Fuxing St., Kwei-Shan
Tao-yuan
333
Taiwan

Sponsor information

Chang Gung University
University/education

No. 259
Wen-Hwa 1st Road
333 Kwei-Shan
Tao-Yuan
333
Taiwan

Website www.cgu.edu.tw
Chang Gung Memorial Hospital
Hospital/treatment centre

No.5, Fuxing Street
Kwei-Shan
Tao-yuan City 333
Tao-yuan
333
Taiwan

Phone +886 (0)3 3281200
Email ycl30@mail.cgu.edu.tw
Chang Gung University
Not defined

Funders

Funder type

University/education

Research Fund of Chang Gung Memorial Hospital and Chang Gung University (BMRPB81; BMRPD67)

No information available

Ministry of Science and Technology, Taiwan (NSC-105-2221-E-182-044; NSC-104-2221-E-182-049)
Government organisation / National government
Alternative name(s)
Ministry of Science and Technology, R.O.C. (Taiwan), Ministry of Science and Technology of Taiwan, MOST
Location
Taiwan

Results and Publications

Intention to publish date30/05/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe trialists intend to publish this study on 30/05/2018.
IPD sharing planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 15/02/2019 Yes No

Editorial Notes

18/02/2019: Publication reference added.