UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056440 |
|---|---|
| Receipt number | R000064497 |
| Scientific Title | Examining the Impact of Continuous Self-Monitoring on Self-Efficacy and Health Behaviors |
| Date of disclosure of the study information | 2024/12/12 |
| Last modified on | 2024/12/12 19:21:51 |
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Basic information
Public title
Examining the Impact of Continuous Self-Monitoring on Self-Efficacy and Health Behaviors
Acronym
Examining the Impact of Continuous Self-Monitoring on Self-Efficacy and Health Behaviors
Scientific Title
Examining the Impact of Continuous Self-Monitoring on Self-Efficacy and Health Behaviors
Scientific Title:Acronym
Examining the Impact of Continuous Self-Monitoring on Self-Efficacy and Health Behaviors
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of continuous self-monitoring on self-efficacy and health behaviors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The between-group difference in changes in Generalized Self-Efficacy Scale before and after the intervention period
Key secondary outcomes
The between-group differences in changes for the following indicators:
- Self-measured items (blood pressure, body weight, body fat, muscle mass, ME-BYO Index)
- Stages of behavior change
- Perceived health awareness
- Self-rated health
- Quality of life (EQ-5D-5L, Single-Item Subjective Happiness Scale)
- Physical activity levels
- Nutritional intake
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Facilities enabling participants to measure blood pressure, body composition, and pre-disease indicators will be installed within their residential area. The intervention group will have free access to these facilities for self-monitoring at least once every two weeks over a period of three months.
Interventions/Control_2
The control group will continue their usual lifestyle for three months, as at the time of enrollment.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Research participants of the Kanagawa ME-BYO Prospective Cohort Study
2. Capable of independently using the application for measuring the ME-BYO Index
3. Does not have a pre-existing habit of continuously self-monitoring the study's measurement items at the time of registration
4. Written consent for participation in the study has been obtained from the individual
Key exclusion criteria
1. Individuals unable to communicate in Japanese
2. Individuals with severe functional impairments that make self-measurement of evaluation items difficult
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Narimatsu |
Organization
Kanagawa Cancer Center Research Institute
Division name
Cancer Prevention and Control Division
Zip code
241-8515
Address
2-3-2, Nakao, Asahi-ku, Yokohama, Kanagawa
TEL
045-520-2222
hiroto-narimatsu@umin.org
Public contact
Name of contact person
| 1st name | Kaname |
| Middle name | |
| Last name | Watanabe |
Organization
Kanagawa Cancer Center Research Insitute
Division name
Cancer Prevention and Control Division
Zip code
241-8515
Address
Cancer Prevention and Control Division
TEL
045-520-2222
Homepage URL
watanabe.5f90l@kanagawa-pho.jp
Sponsor or person
Institute
Kanagawa Cancer Center Research Insitute
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Prefectural Government
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
School of Health Innovation, Kanagawa University of Human Services
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Kanagawa Cancer Center
Address
2-3-2, Nakao, Asahi-ku, Yokohama, Kanagawa
Tel
045-520-2222
clinical_trials@kcch.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 | 12 | Month | 12 | 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
| 2024 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 12 | 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
| 2024 | Year | 12 | Month | 12 | Day |
Last modified on
| 2024 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064497
