UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036859 |
|---|---|
| Receipt number | R000041995 |
| Scientific Title | Development of a new grogram for university students with lifestyle related disease. |
| Date of disclosure of the study information | 2019/05/27 |
| Last modified on | 2024/11/29 11:46:23 |
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Basic information
Public title
Development of a new grogram for university students with lifestyle related disease.
Acronym
Development of a new grogram for university students with lifestyle related disease.
Scientific Title
Development of a new grogram for university students with lifestyle related disease.
Scientific Title:Acronym
Development of a new grogram for university students with lifestyle related disease.
Region
| Japan |
Condition
Condition
lifestyle related disease
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of the new program using arteriosclerosis index and personality assessment to encourage university students with lifestyle related disease to change the health behavior
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changing health behavior within 12 months after starting program
Key secondary outcomes
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Health education
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Students at Shimane university students
2)Students diagnosed lifestyle related disease (hypertension, obesity) at health check
Key exclusion criteria
1)Students with mental illness
2)Students with medication for lifestyle related disease
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Shinobu |
| Middle name | |
| Last name | Sugihara |
Organization
Shimane university
Division name
Health service center
Zip code
690-8504
Address
1060 Nishikawatsu-cho, Matsue-city, Shimane
TEL
0852-32-6568
shinobutozuito@soc.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinobu |
| Middle name | |
| Last name | Sugihara |
Organization
Shimane university
Division name
Health service center
Zip code
690-8504
Address
1060 Nishikawatsu-cho, Matsue-city, Shimane
TEL
0852-32-6568
Homepage URL
shinobutozuito@soc.shimane-u.ac.jp
Sponsor or person
Institute
Shimane university
Institute
Department
Personal name
Funding Source
Organization
Shimane university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shimane University Institutional Committee on Ethics
Address
89-1 enya-cyo, Izumo-city, Shimane-pre.
Tel
0853-20-2515
kenkyu@med.shimane-u.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
| 2019 | Year | 05 | Month | 27 | Day |
Related information
URL releasing protocol
https://health.shimane-u.ac.jp/
Publication of results
Unpublished
Result
URL related to results and publications
https://health.shimane-u.ac.jp/
Number of participants that the trial has enrolled
56
Results
An educational intervention was administered to 27 obese students,13 students (48.1%) (losing weight success group), and 14 students (51.9%)(non-success group). The success group tended to have a long history of obesity and showed a significant increase in behavioral changes in lifestyle habits. Personality assessment also revealed high openness. No significant differences were observed in other test findings. The intervention program examined in this study is useful.
Results date posted
| 2024 | Year | 11 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
University students who underwent regular health checkups were diagnosed as obese and visited the Health Service Center.
Participant flow
Participants who visited the Health Service Center received education on lifestyle-related diseases, dietary advice, and body composition measurements. They were then divided into two groups: those who succeeded in losing weight and those who did not, and an analysis was performed.
Adverse events
non
Outcome measures
Changes in vital parameters such as blood pressure, pulse, weight, BMI, personality traits, and behavioral changes. Personality traits were assessed using the TIPI questionnaire.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2019 | Year | 05 | Month | 27 | Day |
Last modified on
| 2024 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041995
