UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056023 |
|---|---|
| Receipt number | R000064024 |
| Scientific Title | Effectiveness of health promotion intervention in the food environment on dietary behaviors among community-dwelling older adults: a cluster non-randomized controlled trial |
| Date of disclosure of the study information | 2024/11/02 |
| Last modified on | 2025/09/04 08:30:47 |
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Basic information
Public title
Effectiveness of health promotion intervention in the food environment on dietary behaviors among community-dwelling older adults: a cluster non-randomized controlled trial
Acronym
Effectiveness of health promotion intervention in the food environment on dietary behaviors among community-dwelling older adults: a cluster non-randomized controlled trial
Scientific Title
Effectiveness of health promotion intervention in the food environment on dietary behaviors among community-dwelling older adults: a cluster non-randomized controlled trial
Scientific Title:Acronym
Effectiveness of health promotion intervention in the food environment on dietary behaviors among community-dwelling older adults: a cluster non-randomized controlled trial
Region
| Japan |
Condition
Condition
Low diet variety, frailty
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effects of a health promotion intervention, based in community supermarkets as food environment resources, on improving diet variety among community-dwelling older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Changes in diet variety at the 3-year follow-up
Key secondary outcomes
At the 3-year follow-up:
- Changes in the consumption frequency of 10 food items that constitute diet variety questionnaire (fish and shellfish, meat, eggs, milk, soybeans and soybean products, dark green and yellow vegetables, seaweed, potatoes, fruits, and fats and oils).
- Changes in awareness, knowledge, beliefs, and intentions regarding behavior change (diverse food intake).
- Purchasing volume (quantity-based and price-based) of the above 10 food groups in supermarkets.
- Changes in frailty prevalence.
- Changes in physical function.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention Group: For three years, supermarkets assigned to the intervention group will conduct a campaign (intervention) to promote improvement in diet variety (information, education, and support delivery etc.).
Interventions/Control_2
Control Group: For three years, supermarkets assigned to the control group will operate as usual.
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
| 60 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Members of the supermarket chain, which serves as the research field, aged 60 to 84, and who can respond to the survey questionnaire on their own.
Key exclusion criteria
Individuals residing in long-term care facilities, or those unable to visit supermarkets for regular shopping (excluding individuals who, through family assistance or other means, are able to regularly visit supermarkets for daily shopping).
Target sample size
375
Research contact person
Name of lead principal investigator
| 1st name | Tatsunosuke |
| Middle name | |
| Last name | Gomi |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-1141
gomi@tmig.or.jp
Public contact
Name of contact person
| 1st name | Tatsunosuke |
| Middle name | |
| Last name | Gomi |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-1141
Homepage URL
gomi@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Ichiyama Mart Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Meditrina Co., Ltd.
General Incorporated Association Assist Center for Good Health and Longevity
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of the Tokyo Metropolitan Institute for Geriatrics and Gerontology
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
Tel
03-3964-1141
rinsyoushiken@tmghig.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
| 2024 | Year | 11 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 02 | Day |
Last modified on
| 2025 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064024
