Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/03/2020
Date assigned
06/04/2020
Last edited
30/03/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Advances in digital technologies are changing the way elderly care is delivered. Advances in voice technology add a new dimension to health applications. There is a trend for the use of mobile voice-aided applications for daily help in maintaining health. However, the user experience of voice-aided applications by the older population requires further investigation.
The researchers have developed two reporting approaches, namely, voice-only reporting (VOR) and voice button reporting (VBR). Each of the two apps features a unique user interaction design. In the VOR, users report the food items by only using voice interaction, while the VBR allows users to report the food items by voice and button interactions.

Who can participate?
Elderly people between 60 and 90 years of age, capable of reading and operating the application on their mobile phone, and without diabetes, high cholesterol, or high blood pressure.

What does the study involve?
Participants will be randomly allocated to use either the VOR or VBR version of the food reporting app. They will be required to use the app to report their intake over a single day.

What are the possible benefits and risks of participating?
By following this study, the participants will gain knowledge in reporting their dietary intake using voice-based apps. Further to the possible risks, this experiment have no risks for the participants.

Where is the study run from?
Chang Gung Health and Culture Village (Taiwan)

When is the study starting and how long is it expected to run for?
November 2019 to January 2020

Who is funding the study?
Ministry of Science and Technology (Taiwan)

Who is the main contact?
Dr Ying-Chieh Liu
ycl30@mail.cgu.edu.tw

Trial website

Contact information

Type

Public

Primary contact

Dr Ying-Chieh Liu

ORCID ID

http://orcid.org/0000-0003-1876-7632

Contact details

Chang Gung University
No.259
Wenhua 1st Rd.
Guishan Dist.
Taoyuan City
33302
Taiwan
+886 (0)955340448
ycl30@mail.cgu.edu.tw

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

201900324B0

Study information

Scientific title

The assessment of mobile voice-based interaction on food reporting for the elderly: a randomized controlled trial

Acronym

Study hypothesis

This study seeks to develop and assess the relative effectiveness and acceptability of two app prototypes in tests of elderly reporting their food intakes in realistic contexts.

Ethics approval

Approved 24/05/2019, Ethics Committee of Chang Gung Memorial Hospital (No. 199, Dunhua North Road, Taipei 105, Taiwan; +886 33196200#3716; yijiun@cgmh.org.tw), ref: 201900324B0

Study design

Interventional randomized parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Community

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Dietary intake

Intervention

Each participant will complete a questionnaire to collect background and baseline data that allows the assistant researchers to contact them and perform randomization. The baseline data will be randomized to allocate participants either to the voice-only or voice button reporting group. To ensure an even age distribution, two random number lists will be generated by SAS software (SAS Institute Inc, Cary, North Carolina).

Older adults aged 60-90 are recruited and randomized into two experimental groups, i.e., namely voice-only reporting (VOR) and voice button reporting (VBR). Each of the groups utilize a specific app featuring a unique user interaction design. In the VOR, users report the food items by only using voice interaction, while the VBR allows users to report the food items by voice and button interactions. Seventeen food items will be used in the experiment, mimicking three-set meals, breakfast, lunch, and dinner.

All participants use a 7-inch Android tablet for the test, and all participant trials will be conducted on a single day. Each participant is tested one-by-one for about one hour each. Each participant first watches an instructional video explaining the operation of the mobile app and the food reporting method each participant is assigned to use. Following the written and video instructions, the researchers spend several minutes teaching each participant how to navigate to ensure familiarity with the app’s operation and features and conduct a ‘dry-run’ which involves assessing voice reporting of five food items which are presented on a photo-board. Participants will be encouraged to use the system to assess these items until they feel comfortable with the application’s operations. For the trial, participants will be informed that their time to completion is also a performance consideration.

Three set meals are arranged under Chang Gung Memorial Hospital’s nutritionist supervision based on typical Taiwanese foods. Three set meals represented breakfast, lunch, and dinner. Each set meal contained staple food, a single dish, a dish with two ingredients, a dish with three ingredients, and a beverage. These set meals will be presented in 1:1 colored food-photo-boards (30cm x 42cm). Food name tags (font-size = 72pt) will be placed on the above or below each food picture with the order number from bottom-left to top-right.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Accuracy of reporting measured using reporting errors made in the app at the time of the intervention
2. Response time recorded and embedded in apps in milliseconds for the time elapsed from a user’s voice food reporting to completion

Secondary outcome measures

Participants’ perceptions of the utility of each app were measured using the System Usability Scale (SUS), with ten items scored using a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree) at the end of the intervention.

Overall trial start date

30/03/2019

Overall trial end date

19/01/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 60 - 90 years of age
2. Capable of reading and operating the application on their mobile phone

Participant type

Healthy volunteer

Age group

Senior

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Under any form of dietary control
2. Engaged in deliberate weight loss
3. On medication
4. Pregnant
5. Diabetes
6. High cholesterol
7. High blood pressure

Recruitment start date

08/11/2019

Recruitment end date

15/01/2020

Locations

Countries of recruitment

Taiwan

Trial participating centre

Chang Gung Health and Culture Village
No. 2, Changqing Rd. Guishan Dist.
Taoyuan
333
Taiwan

Sponsor information

Organisation

Ministry of Science and Technology

Sponsor details

106
Sec. 2
Heping E. Rd.
Taipei
10622
Taiwan
+886 227377992
misservice@most.gov.tw

Sponsor type

Government

Website

https://www.most.gov.tw/

Funders

Funder type

Government

Funder name

Ministry of Science and Technology, Taiwan

Alternative name(s)

Ministry of Science and Technology of Taiwan, MOST

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Taiwan

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement
The current data with anonymization can be requested based on ethical committee review and approval. The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/03/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

30/03/2020: Trial’s existence confirmed by Chang Gung Medical Foundation IRB.