UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038157 |
|---|---|
| Receipt number | R000043494 |
| Scientific Title | Association between the neighborhood food environment and dietary variety in Japanese rural community-dwelling older adults: a cross-sectional study |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2021/02/09 14:14:43 |
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Basic information
Public title
Association between the neighborhood food environment and dietary variety in Japanese rural community-dwelling older adults: a cross-sectional study
Acronym
Association between the neighborhood food environment and dietary variety in Japanese rural community-dwelling older adults: a cross-sectional study
Scientific Title
Association between the neighborhood food environment and dietary variety in Japanese rural community-dwelling older adults: a cross-sectional study
Scientific Title:Acronym
Association between the neighborhood food environment and dietary variety in Japanese rural community-dwelling older adults: a cross-sectional study
Region
| Japan |
Condition
Condition
Dietary variety
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between neighborhood food environment and dietary variety in Japanese rural community-dwelling elderly.
Basic objectives2
Others
Basic objectives -Others
Observational study aimed to examine relationship.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Dietary variety assessed by dietary variety score (DVS).
DVS is calculated from the intake frequency of 10 food item (meat, fish/shellfish, eggs, milk, soybean products, green/yellow vegetables, potatoes, fruit, seaweed, and fats/ oils) (Kumagai, Nihon Koshu Eisei Zasshi, 2003 (in Japanese)).
Key secondary outcomes
Frequency of intake for each of the 10 food groups used to evaluate DVS.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| 82 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The participants of this study were who participated "Effectiveness of community-wide promotion of physical activity in middle-aged and older adults: a dissemination study"(UMIN000024682)* who were 65 years or more and responded to the survey of the second year of intervention (November 2018).
* This intervention study is a community-wide intervention for the Uunnan city, and the evaluation is conducted by mail survey of 7,000 people randomly selected from all citizens aged 40 to 79 years. The participants of the second-year survey were those who responded to the baseline survey.
Key exclusion criteria
People who need someone's assistance to go outside.
Target sample size
1650
Research contact person
Name of lead principal investigator
| 1st name | Tatsunosuke |
| Middle name | |
| Last name | Gomi |
Organization
Physical Education and Medicine Research Center UNNAN
Division name
Research Division
Zip code
699-1105
Address
328 Uji, Kamo Town, Unnan City, Shimane Prefecture, 699-1105, Japan
TEL
0854-49-9050
challenge533.0701@gmail.com
Public contact
Name of contact person
| 1st name | Tatsunosuke |
| Middle name | |
| Last name | Gomi |
Organization
Physical Education and Medicine Research Center UNNAN
Division name
Research Division
Zip code
699-1105
Address
328 Uji, Kamo Town, Unnan City, Shimane Prefecture, 699-1105, Japan
TEL
0854-49-9050
Homepage URL
shintai@bs.kkm.ne.jp
Sponsor or person
Institute
Physical Education and Medicine Research Center UNNAN
Institute
Department
Personal name
Funding Source
Organization
Japanese Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Physical Education and Medicine Research Center UNNAN
Address
328 Uji, Kamo Town, Unnan City, Shimane Prefecture, 699-1105, Japan
Tel
0854-49-9050
shintai@bs.kkm.ne.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jea/advpub/0/advpub_JE20200415/_article/-char/en
Number of participants that the trial has enrolled
1103
Results
In multivariate analysis by distance to nearest food store, there was a significantly higher prevalence ratio (PR) (1.15, 95% CI, 1.01-1.32) for low DVS only in Q4 (1,784 m-7,780 m). There was also a significant trend (p for trend = 0.033) between low DVS and distance to nearest food store. The results were similar for analyses in the crude model.
Results date posted
| 2021 | Year | 02 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
2,110 men and women who were age 65 to 81 years in 2018 were invited to participate in the present study. Of those invited, 1,763 (53.3%) consented to participate; however, 69 respondents were subsequently excluded because they met the exclusion criteria. Another 591 respondents with uncertain or missing answers to the questions were excluded. Consequently, data from 1,103 participants were analyzed.
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 08 | Month | 20 | Day |
Other
Other related information
Authors and Contributors: Mr.Tatsunosuke Gomi, Dr. Jun Kitayuguchi, Prof. Hiroharu Kamioka, Mr. Kenta Okuyama, Dr.Masamitsu Kamada, Dr.Shigeru Inoue, Dr. Yoshiteru Mutoh. TG (steering author) and JK conceive the study and will perform the statistical analyses, MK and SI will provide expert advice on research and analysis. KO will perform data analyses using Geographic information system (GIS), HK and YM will conduct interpretation of data.
Participants are residents of Unnan City and over 65 years old. Neighborhood food environment will be quantified using GIS and be used as an exposure factor. Finding from the exposure group are compared with those from a better neighborhood food environment group. We will analyze the relationship between neighborhood food environment and dietary variety as an outcome.
This study is a cross-sectional study.
As the first subanalysis, we will analyze the relationship between subjective food accessibility and dietary variety.
As a second subanalysis, we will analyze the relationship between the density of grocery stores in the neighborhood and dietary variety.
Subgroup analysis will be performed for men and women, driving status, and residence patterns.
As a sensitivity analysis, we investigate the quantitative response between distant food environment and dietary variety score.
Management information
Registered date
| 2019 | Year | 09 | Month | 30 | Day |
Last modified on
| 2021 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043494
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