UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047882 |
|---|---|
| Receipt number | R000054590 |
| Scientific Title | Intervention study (pre-post comparison test) |
| Date of disclosure of the study information | 2022/05/27 |
| Last modified on | 2023/06/26 13:43:26 |
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Basic information
Public title
Educational Effectiveness of a Low Nutrition Prevention Awareness Video at a "Passing Place" for the Elderly
Acronym
Educational Effectiveness of a Low Nutrition Prevention Awareness Video at a "Passing Place" for the Elderly
Scientific Title
Intervention study (pre-post comparison test)
Scientific Title:Acronym
Intervention study (pre-post comparison test)
Region
| Japan |
Condition
Condition
Low nutrition in the elderly
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct an intervention using an educational video on prevention of low nutrition for the elderly created by the joint research institute, and to verify its educational effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BMI
Key secondary outcomes
Food Diversity Score
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
1) Short-term course (one time only): One video will be viewed and a questionnaire survey will be conducted before and after the video. 2) Medium-term course (3 months): The first session is the same as the short-term course. After one month and two months, monitoring will be conducted by weight measurement and food checklist. 3 months later, weight measurement and food checklist will be checked, and final evaluation will be conducted by questionnaire survey.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The joint research institute will simultaneously conduct an intention survey through the municipalities in its jurisdiction to solicit the heads of facilities of "places for elderly people to go" for (1) short-term courses (about 40 places) and (2) medium-term courses (about 100 people in about 5 places).
Selection criteria: Based on the results of the intention survey, the joint research institute will implement the course that the "day-care center" facilities that are willing to cooperate with us wish to offer.
Key exclusion criteria
Facilities for "places to go" that do not cooperate with the results of the intention survey conducted by the collaborating institutions.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | kazue |
| Middle name | |
| Last name | suzuki |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Nutrition
Zip code
0252574421
Address
1398 Shimami -cho, Kita-ku, Niigata 950-3198, Japan
TEL
0252574421
kazue-suzuki@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | kazue |
| Middle name | |
| Last name | suzuki |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Nutrition
Zip code
9503198
Address
1398 Shimami -cho, Kita-ku, Niigata 950-3198, Japan
TEL
0252574421
Homepage URL
kazue-suzuki@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Health, Welfare and Environment Department, Nagaoka Regional Promotion Bureau, Niigata Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Niigata University of Health and Welfare
Address
1398 Shimami -cho, Kita-ku, Niigata 950-3198, Japan
Tel
0252574455
rinri@nuhw.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.pref.niigata.lg.jp/sec/nagaoka_kenkou/20200406program.html
Number of participants that the trial has enrolled
48
Results
In the "3-month course," weight measurements were more frequent after the intervention than before (p<0.05). In addition, total food diversity scores were higher after the intervention than before (p<0.001), and among food groups, the number of participants who ate meat, seafood, seaweed, potatoes, and fruit daily significantly increased after the intervention.
Results date posted
| 2023 | Year | 06 | Month | 26 | Day |
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
Completed
Date of protocol fixation
| 2022 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 27 | Day |
Last modified on
| 2023 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054590
