UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000022396
Receipt No. R000025626
Scientific Title Effects of monetary incentive on choices of healthy dishes in restaurants: open-labeled non-randomized before-after trial
Date of disclosure of the study information 2016/05/31
Last modified on 2019/12/02 (Ver. 9)

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

Basic information
Public title Effects of monetary incentive on choices of healthy dishes in restaurants: open-labeled non-randomized before-after trial
Acronym Effects of monetary incentive on choices of healthy dishes in restaurants
Scientific Title Effects of monetary incentive on choices of healthy dishes in restaurants: open-labeled non-randomized before-after trial
Scientific Title:Acronym Effects of monetary incentive on choices of healthy dishes in restaurants
Region
Japan

Condition
Condition Low vegetable intake
Classification by specialty
Not applicable Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aims of this survey are as follows: first, to confirm that monetary incentive increases the choices of dishes with additional vegetable, compared to no incentive; second, to examine the sociodemographic characteristic difference between the groups with/without monetary incentive; third, to investigate whether the motivation of healthy-dishes choices is different between groups with/without monetary incentive, and is affected by people's characteristics.
Basic objectives2 Others
Basic objectives -Others Effectiveness study of the monetary incentive
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Ratio of the order of vegetable-rich menus in intervention sessions compared to control
Key secondary outcomes Before-after differences in the proportions of sociodemographic characteristics among those who ordered vegetable-rich menus.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Intervention period: campaign of 50-yen-discount of the vegetable-rich menus is hold for a week after control period.
Control period: The vegetable-rich menus are sold with regular price for a week.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria None
Key exclusion criteria People who cannot read Japanese
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name Naoki
Middle name
Last name Kondo
Organization The University of Tokyo
Division name Department of Health Sociology and Health Education, School of Public Health, Graduate School of Medicine
Zip code 113-0033
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL 03-5841-3513
Email naoki-kondo@umin.ac.jp

Public contact
Name of contact person
1st name Wataru
Middle name
Last name Nagatomo
Organization The University of Tokyo
Division name Department of Health Sociology and Health Education, School of Public Health, Graduate School of Med
Zip code 113-0033
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL 03-5841-3514
Homepage URL
Email wnagatomo-tky@umin.ac.jp

Sponsor
Institute Department of Health Sociology and Health Education, School of Public Health, Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Schience
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Ethics Committee, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
Tel 03-5841-0818
Email ethics@m.u-tokyo.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 足立区ベジタベライフ活動協賛店（東京都）

Other administrative information
Date of disclosure of the study information
2016 Year 05 Month 31 Day

Related information
URL releasing protocol https://ijbnpa.biomedcentral.com/articles/10.1186/s12966-019-0830-5
Publication of results Published

Result
URL related to results and publications https://ijbnpa.biomedcentral.com/articles/10.1186/s12966-019-0830-5
Number of participants that the trial has enrolled 1491
Results 
During the intervention period, the covariate-adjusted proportion of vegetable-rich meal orders was 1.50 times higher than the control period.

Respondents who reported spending the least amount of money on eating out (used as a proxy measure for income) were the least likely to order vegetable-rich meals during the control period. However, these individuals increased the most their proportion of purchasing such meals during the intervention period.
Results date posted
2019 Year 12 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 09 Month 12 Day
Baseline Characteristics 
Restaurants: 26 restaurants at the government of Adachi Ward, which collaborates in the government's program

Individuals: People who ordered meals at the 26 restaurants during control and intervention period
Participant flow 
For all customers who ordered vegetable-rich meals, restaurant staff members asked them after the order was placed to answer a questionnaire, during both the control and the intervention periods.

We also surveyed customers who visited and did not ordered vegetable-rich meals during a randomly selected one-hour period during both the control and intervention periods at each restaurant.
Adverse events 
None
Outcome measures 
The ratio of proportion of vegetable-rich meal orders during intervention period to that during control period
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 05 Month 27 Day
Date of IRB
2016 Year 04 Month 27 Day
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
2016 Year 06 Month 30 Day
Date of closure to data entry
2016 Year 07 Month 29 Day
Date trial data considered complete
2016 Year 08 Month 31 Day
Date analysis concluded
2019 Year 01 Month 15 Day

Other
Other related information

Management information
Registered date
2016 Year 05 Month 21 Day
Last modified on
2019 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025626