UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052034 |
|---|---|
| Receipt number | R000057703 |
| Scientific Title | The health education program for local residents in Ginowan City, Okinawa, Japan |
| Date of disclosure of the study information | 2023/09/19 |
| Last modified on | 2024/06/25 09:22:17 |
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Basic information
Public title
The health education program for local residents in Ginowan City, Okinawa, Japan
Acronym
Ginowan Kenko Project 1
Scientific Title
The health education program for local residents in Ginowan City, Okinawa, Japan
Scientific Title:Acronym
Ginowan Kenko Project 1
Region
| Japan |
Condition
Condition
lifestyle-related disease
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of health education using a health app on the health literacy of residents in Okinawa Prefecture.
Basic objectives2
Others
Basic objectives -Others
To investigate the impact of health education using a health app on behavioral change in food and physical activity of residents in Okinawa Prefecture.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in health literacy scale (continuous variable)
Key secondary outcomes
1. change in the subjective view of health (category)
2. behavior change related to eating habits (category)
3. Behavior change related to exercise habits (category)
4. Behavior change related to the use of health apps (category)
5. Changes in Global Physical Activity Questionnaire (GPAQ) scores (continuous variables and categories)
6. Changes in body weight and body mass index (BMI) (continuous variables)
7. Changes in health checkup behavior (categorical)
8. Changes in participation in community activities (category)
9. Change in weight entered into the health app (continuous variable)
10. Change in the number of steps entered into the health application (continuous variable)
11. Change in blood pressure entered into the health app (continuous variable)
12. Change in sleep time entered into the health app (continuous variable)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Online health education will be provided to residents in the intervention neighborhood association after the baseline survey (intervention group) for one year. In addition, health promotion hybrid-style seminars will be held regularly (on-demand delivery) in the intervention neighborhood association.
Interventions/Control_2
Residents in non-intervention neighborhood associations (control group) will conduct their own health promotion activities.
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
1. Adults 18 years of age or older residing in the Ginowan City Community Association
2. Subjects who agree to use aurora, a health application developed by Okinawa Prefecture
Key exclusion criteria
1. Subjects who are judged by the investigator to be medically unfit to participate in the study.
2. Patients who have complications of diseases for which prognosis is defined
3. Patients who had a stroke, myocardial infarction, or heart failure within six months
4. Patients who developed cancer within five years
5. Patients with severe liver dysfunction (liver cirrhosis)
6. Patients with severe renal dysfunction (dialysis patients)
7. Patients with dementia
Target sample size
320
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Sakima |
Organization
University of the Ryukyus
Division name
Health Administration Center
Zip code
903-0213
Address
Senbaru 1 Nishihara-cho, Okinawa, Japan
TEL
098-895-8144
asakima@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Sakima |
Organization
University of the Ryukyus
Division name
Health Administration Center
Zip code
093-0213
Address
Senbaru 1 Nishihara-cho, Okinawa, Japan
TEL
098-895-8144
Homepage URL
asakima@med.u-ryukyu.ac.jp
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
Sakima Atsushi
Funding Source
Organization
Ginowan City, Okinawa Prefecture, Japan
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Okinawa International University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of University of the Ryukyus for Medical and Health Research Involving Human Subjects
Address
Uehara 207 Nishihara-cho, Okinawa, Japan
Tel
098-895-1543
krinken@acs.u-ryukyu.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
| 2023 | Year | 09 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 29 | Day |
Last modified on
| 2024 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057703
