UMIN-ICDS Clinical Trial

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

Lifestyle diseases

Classification by specialty

Nursing

Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

reiko.okahisa@tokushima-u.ac.jp

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

Email

reiko.okahisa@tokushima-u.ac.jp

Institute

Tokushima University

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The Ethics Committee of Tokushima University Hospital

Address

2-50-1 Kuramoto-cho, Tokushima city, Tokushima, Japan

Tel

088-633-9294

Email

awachiken@tokushima-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

05

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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/icdr_e/ctr_view.cgi?recptno=R000058200