UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052892 |
|---|---|
| Receipt number | R000060348 |
| Scientific Title | Association between behavior change in dietary variety and providing information about others; Randomized Controlled Trial for residents in Kakara island |
| Date of disclosure of the study information | 2023/11/24 |
| Last modified on | 2024/08/20 15:32:00 |
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Basic information
Public title
Association between behavior change in dietary variety and providing information about others
Acronym
BDVI
Scientific Title
Association between behavior change in dietary variety and providing information about others; Randomized Controlled Trial for residents in Kakara island
Scientific Title:Acronym
BDVI-RCT
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will clarify association between behavior change in dietary variety and providing information about others.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
dietary variety score of a week after intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
We will not provide the information that one out of five Japanese has a score of 7 or higher.
Interventions/Control_2
We provide the information that one out of five Japanese has a score of 7 or higher.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Residents of Kakara island in Japan
Key exclusion criteria
1. Patient treated by an intense (two or more items) diet
2. Persons who is not able to take two or more items due to food allergies or religious reasons
3. Patient with dementia
Target sample size
1570
Research contact person
Name of lead principal investigator
| 1st name | Riichiro |
| Middle name | |
| Last name | Ikeuchi |
Organization
Karatsu Munisipal Hospital
Division name
Karatsu Medical Educational Center for General Medicine
Zip code
8471201
Address
1424-1 Kitahata Tokusue, Karatsu, Saga, Japan
TEL
0955642611
m11004ri@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Riichiro |
| Middle name | |
| Last name | Ikeuchi |
Organization
Karatsu Munisipal Hospital
Division name
Karatsu Medical Educational Center for General Medicine
Zip code
8471201
Address
1424-1 Kitahata Tokusue, Karatsu, Saga, Japan
TEL
0955642611
Homepage URL
m11004ri@jichi.ac.jp
Sponsor or person
Institute
Karatsu Medical Educational Center for General Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Karatsu City Kakarajima Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ethics committee of Karatsu Munisipal Hospital
Address
1424-1 Kitahata Tokusue, Karatsu, Saga, Japan
Tel
0955642611
m11004ri@jichi.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
唐津市加唐島診療所（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 24 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
81
Results
The mean DVS for the intervention group was 7.45 and 6.93 for the control group, but the difference was not significant (p value = 0.2782).
Results date posted
| 2023 | Year | 11 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age was 64.3 years in the control group and 69.9 years in the intervention group. The proportion of men was 23.3% in the control group and 34.2% in the intervention group. The mean height was 155 cm in the control group and 157 cm in the intervention group. The mean weight was 62.3 kg in the control group and 60.5 kg in the intervention group. No significant differences were observed.
Participant flow
Of the 120 patients who agreed to participate in the study, 81 were subsequently enrolled as eligible subjects, excluding 39 who were excluded from enrollment. These 81 patients were consecutively randomly assigned to the control group (43 patients) and the intervention group (38 patients). In the case review meeting after the completion of all test stages, no significant deviations from the protocol were identified in either group.
Adverse events
None
Outcome measures
Dietary Variety Score; DVS
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 24 | Day |
Last modified on
| 2024 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060348
