UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019535 |
|---|---|
| Receipt number | R000022276 |
| Scientific Title | Effect of school-based program to reduce non-obese dieting behavior in Japanese adolescents. |
| Date of disclosure of the study information | 2015/10/28 |
| Last modified on | 2023/12/03 20:32:49 |
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Basic information
Public title
Effect of school-based program to reduce non-obese dieting behavior in Japanese adolescents.
Acronym
School-based program to reduce non-obese dieting behavior in Japanese adolescents.
Scientific Title
Effect of school-based program to reduce non-obese dieting behavior in Japanese adolescents.
Scientific Title:Acronym
School-based program to reduce non-obese dieting behavior in Japanese adolescents.
Region
| Japan |
Condition
Condition
dieting behavior
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness of the school-based programs on healthy eating and dieting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Self-reported dieting behavior of non-obese students after two months from the intervention
Key secondary outcomes
Importance and confidence levels of healthy eating and dieting after two months from the intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention group had two lessons on the same day spending 50 minutes each on healthy eating and weight control.
Interventions/Control_2
The comparison group received two lessons on the same day spending 50 minutes on smoking prevention .
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
| 15 | years-old | <= |
Age-upper limit
| 16 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Six classes of 236 first-year students from the public high school
Key exclusion criteria
We excluded the students who did not attend pre-test or post -intervention assessment,the students whose BMI was equal to and higher than 25 m2/kg, and the students missing BMI data.
Target sample size
156
Research contact person
Name of lead principal investigator
| 1st name | Ryuki |
| Middle name | |
| Last name | Kassai |
Organization
Fukushima Medical University
Division name
Department of community and Family Medicine
Zip code
9601295
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture, Japan
TEL
024-547-1516
rukikas@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Naomi |
Organization
Fukushima Medical University
Division name
Department of Community and Family Medicine
Zip code
9601295
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture, Japan
TEL
024-547-1516
Homepage URL
tiune88@hotmail.com
Sponsor or person
Institute
Department of Community and Family Medicine, Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Community and Family Medicine, Fukushima Medical University
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture, Japan
Tel
024-547-1516
tiune88@hotmail.com
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
福島県立保原高校（福島県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 28 | 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
There was no significant decrease in dieting behavior. The intervention group reported increased importance levels for healthy eating and confidence levels for healthy dieting (p = 0.02, p = 0.04). The intervention group also maintained high importance levels of healthy eating more than the comparison group (p = 0.04).
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
Completed
Date of protocol fixation
| 2009 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 16 | Day |
Date of closure to data entry
| 2011 | Year | 01 | Month | 27 | Day |
Date trial data considered complete
| 2011 | Year | 01 | Month | 27 | Day |
Date analysis concluded
| 2015 | Year | 11 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 28 | Day |
Last modified on
| 2023 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022276
