UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051141 |
|---|---|
| Receipt number | R000058323 |
| Scientific Title | Investigation of the usefulness of health education focusing on the perception of one's own body shape and self-acceptance during adolescence. |
| Date of disclosure of the study information | 2023/05/23 |
| Last modified on | 2023/05/23 17:15:20 |
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Basic information
Public title
Investigation of the usefulness of health education focusing on the perception of one's own body shape and self-acceptance during adolescence.
Acronym
Investigation of the usefulness of health education focusing on the perception of one's own body shape and self-acceptance during adolescence.
Scientific Title
Investigation of the usefulness of health education focusing on the perception of one's own body shape and self-acceptance during adolescence.
Scientific Title:Acronym
Investigation of the usefulness of health education focusing on the perception of one's own body shape and self-acceptance during adolescence.
Region
| Japan |
Condition
Condition
Eating Disorder
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop an intervention program for health education that focuses on the awareness of one's own body shape, thinness ideals, dieting, and other so-called eating disorder tendencies that are of interest to junior high school students in their adolescent years, and on self-acceptance, which is considered important for the psychological development of this age group, and to examine its usefulness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-Acceptance Rating Scale for Junior High School Students
Measured before program intervention, immediately after intervention, and 3 months after intervention.
Key secondary outcomes
Children's Edition EAT-26
The Ideal-Body Stereotype Scale-Revised
The Body Dissatisfaction Screening Scale
Measured before program intervention, immediately after intervention, and 3 months after intervention.
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
A self-acceptance promotion program focusing on eating disorder tendencies will be implemented in three sessions. Only the first session will last approximately 60 minutes in order to provide an introduction on eating habits and media literacy, and each subsequent session will last approximately 45 minutes. The interval between Session I and the next session should be approximately one week for Session II and approximately two weeks for Session II and Session III. Since Session I uses cognitive dissonance theory to implement content related to the ideal of thinness, thin thinking, and healthy body shape, the interval between sessions should be approximately one week in order to smoothly introduce the effects of cognitive dissonance into the next session. The interval between the next sessions will be approximately 2 weeks in order to smoothly introduce the effects of cognitive dissonance into the next session.
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
| 12 | years-old | <= |
Age-upper limit
| 14 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects of this study will be first- and second-year junior high school students, male and female, enrolled in a regular junior high school class who are able to attend school and attend classes on a daily basis at the start of the intervention.
Since junior high school students are minors, those who have obtained the consent of the students themselves and their parents or guardians will be eligible.
Key exclusion criteria
Students enrolled in support classes shall be excluded from the recruitment process.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Nakamura |
Organization
Tokyo Healthcare University
Division name
Faculty of Nursing
Zip code
152-8558
Address
2-5-1 Higashigaoka, Meguro, Tokyo
TEL
03-5779-5031
h-nakamura@thcu.ac.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Nakamura |
Organization
Tokyo Healthcare University
Division name
Faculty of Nursing
Zip code
152-8558
Address
2-5-1 Higashigaoka, Meguro, Tokyo
TEL
03-5779-5031
Homepage URL
h-nakamura@thcu.ac.jp
Sponsor or person
Institute
Tokyo Healthcare University
Institute
Department
Personal name
Hiromi Nakamura
Funding Source
Organization
Tokyo Healthcare 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
Toho University School of Nursing Ethics Review Committee
Address
5-21-16 Omorinishi, Ota, Tokyo
Tel
03-3762-4151
h-nakamura@thcu.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 | 23 | 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
31
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 01 | 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 | 23 | Day |
Last modified on
| 2023 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058323
