UMIN-CTR Clinical Trial

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
Email	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
Email	shintai@bs.kkm.ne.jp

Sponsor
Institute	Physical Education and Medicine Research Center UNNAN
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043494