UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051070 |
|---|---|
| Receipt number | R000058200 |
| Scientific Title | Development of a Lifestyle Change Support Program Using a Strengths Perspective -Effectiveness Verification in Nursing University Students- |
| Date of disclosure of the study information | 2023/05/16 |
| Last modified on | 2023/05/16 12:58:49 |
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Basic information
Public title
Development of a lifestyle improvement support program with a strengths perspective and verification of its effectiveness in nursing university students
Acronym
Development of a strengths-based lifestyle improvement support program
Scientific Title
Development of a Lifestyle Change Support Program Using a Strengths Perspective -Effectiveness Verification in Nursing University Students-
Scientific Title:Acronym
Development of a strengths-based lifestyle change support program
Region
| Japan |
Condition
Condition
Lifestyle diseases
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a lifestyle change support program using a strengths perspective. Specifically, it is the construction of a strengths-oriented support program that combines the population approach and self-monitoring, which is considered effective in previous research as a support methods for behavior change, and the effect verification for nursing university students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome measure: average number of steps
One month after the self-monitoring experience using an activity meter is taken as the starting point of the study. The intervention group receive support with a strength perspective and set individual lifestyle improvement goals, while the control group receive support without a strength perspective, and then individual lifestyles goals.
Subsequent evaluations will be made 1 month and 2 months after the start of the study for both groups.
Key secondary outcomes
Secondary outcomes: weight,body fat percentage, average calorie consumption, sleep score, stress score, degree of achievement of lifestyle improvement goals (%), change in strength scale score (intervention group only)
The evaluation period will be 1 month and 2 months after the start of the study for both groups.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
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
The intervention group is the strengths-oriented program implementation group.
After one month of self-monitoring using an activity meter, the study will begin. At the beginning time of this study, students will know their own strengths by strengths measurement scale, then divide into groups according to their strengths type, and they provide group work on how to improve their lifestyle habits by making use of their strengths.
Specifically, by self-checking their strengths, they know which type of strength they have:"utilization,""reconstruction,"" Connectedness,"and"Self-awareness."and discuss about lifestyle changes by characteristics of one's own strengths, and then setting individual lifestyle improvement goals are established.
And one month and two months later, self-monitoring such as the average number of steps, body measurements, self-evaluation of the degree of goal achievement are performed, and the goal is reviewed.
Interventions/Control_2
The control group is a standard support program implementation group.
After one month of self-monitoring using an activity meter, at the start of the study, the group work about the factors that lead to behavioral change is conducted, and then individual goals are set.
One month and two months later,self-monitoring such as the average number of steps, body measurements, self-evaluation of the degree of goal achievement are performed, and the goal is reviewed.
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
| 20 | years-old | <= |
Age-upper limit
| 25 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The selection criteria for the subjects were (1) 3rd grade nursing students who have selected the public health nursing course and are taking "Methodology of public health nursing", (2) self-monitoring experience for one month in class before the research, and (3) students who received the explanation about this study at the study start time, and then agreed to this study.
Key exclusion criteria
Those who do not intend to consent to this study are excluded. In addition, cases where it becomes difficult to continue the program specified in the eligibility criteria above will also be excluded.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Okahisa |
Organization
Tokushima University
Division name
Department of Community Health Nursing, Graduate School of Biomedical Sciences
Zip code
770-8509
Address
3-18-15 Kuramoto-cho, Tokushima city, Tokushima, Japan
TEL
088-633-9977
reiko.okahisa@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Okahisa |
Organization
Tokushima University
Division name
Department of Community Health Nursing, Graduate School of Biomedical Sciences
Zip code
770-8509
Address
3-18-15 Kuramoto-cho, Tokushima city, Tokushima, Japan
TEL
088-633-9977
Homepage URL
reiko.okahisa@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokushima University Hospital
Address
2-50-1 Kuramoto-cho, Tokushima city, Tokushima, Japan
Tel
088-633-9294
awachiken@tokushima-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
| 2023 | Year | 05 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | 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 | 05 | Month | 16 | Day |
Last modified on
| 2023 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058200
