UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000023749
Receipt No. R000027362
Scientific Title Verifiying the effectiveness of the primary diabetes prevention education program for young adults
Date of disclosure of the study information 2016/11/01
Last modified on 2019/09/12 (Ver. 10)

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Basic information
Public title Verifiying the effectiveness of the primary diabetes prevention education program for young adults
Acronym Verifiying the effectiveness of the primary diabetes prevention education program for young adults
Scientific Title Verifiying the effectiveness of the primary diabetes prevention education program for young adults
Scientific Title:Acronym Verifiying the effectiveness of the primary diabetes prevention education program for young adults
Region
Japan

Condition
Condition Diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We intend to develop an effective education intervention program to prevent diabetes for young adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in knowledge, recognition (Perceived Health Competence Scale, the extent to which an individual is aware of the susceptibility for diabetes) related to their health management and diabetes prevention
Key secondary outcomes Change in behaviors (dietary behaviors, amount of physical activity and utilization of annual health check-ups results) related to their health management and diabetes prevention, and the stage of behavior change
Change in waist circumference size


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Researchers provided diabetes prevention education program that is based on the Health Belief Model and the Revised Health Promotion Model. The intervention group received 6 original brochers and movies appropriate for young adults. The education period was 6 weeks.
Interventions/Control_2 The control group didn't receive the education program that was provided for the intervention group.
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
39 years-old >=
Gender Male and Female
Key inclusion criteria Participants who is interested in the diabetes prevention education and lifestyle modification
Key exclusion criteria Patient who is in treatment or take medicine for lifestyle deseases
Target sample size 210

Research contact person
Name of lead principal investigator
1st name Morita
Middle name
Last name Kumiko
Organization Tokyo Medical and Dental University
Division name Graduate School of Health Care Sciences
Zip code 113-8510
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo113-8510, Japan
TEL 03-5803-5337
Email morita.phn@tmd.ac.jp

Public contact
Name of contact person
1st name Hitomi
Middle name
Last name Nagamine
Organization Tokyo Medical and Dental University
Division name Graduate School of Health Care Sciences
Zip code 113-8510
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo113-8510, Japan
TEL 03-5803-5337
Homepage URL
Email ns140002@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical Research Ethics Committee of Tokyo Medical and Dental University
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo113-8510, Japan
Tel 03-5803-4085
Email infobec@tmd.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
2016 Year 11 Month 01 Day

Related information
URL releasing protocol I will announce future
Publication of results Unpublished

Result
URL related to results and publications I will announce future
Number of participants that the trial has enrolled 311
Results 
We investgage for 311 participants, and finaly 129 interventions and 141 controls completed the trial. The intervention group recognized that their knowledge about diabetes prevention had increased (p<0.05) compared with the controls.The recognition of their susceptibility to diabetes of intervention group increased (p=0.029) compared with the controls. Regarding dietary behavior and the level of dietary behavior change, the intervention group improved more than the controls (p<0.05).
Results date posted
2019 Year 09 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
the participants of this study were employees who worked as automobile mechanics or office clerks at two automobile sales companies in Japan
Participant flow 
Participants were informed about this study in writing before the start of this study. The intervention media was distributed for all participants of an intervention group. Consent for participation was assumed by return of questionnaires. In order to maintain anonymity of participants, we distributed the multiple questionnaires inside a folder that was marked with a coded ID for each participant that was kept at the workplace. At designated times, we sent all participants a prompt to retrieve the appropriate questionnaire from their folder, respond, and return to us. Baseline data was collected in November 2016. Distribution of educational media to the intervention group was implemented over the six week period extending from January to February 2017. For the intervention group, questionnaires were collected twice, at the end of intervention and 4 weeks later (at the ends of February and March 2017), whereas data collection from the control group was only performed one time (at the end of March 2017).
Adverse events 
None
Outcome measures 
knowledge items about diabetes prevention,12 items, Likert scale
VAS score of the recognition of their susceptibility to diabetes
The Perceived health Competence scale score
The dietary behavior 9 items and the level of dietary behavior change, 5 stages, Likert scale
METS-minutes per day from the International Physical Activity Questionnaire Short Version, for evaluating self-reported recent average level of physical activity
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
2016 Year 10 Month 29 Day
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
2017 Year 06 Month 30 Day
Date of closure to data entry
2017 Year 06 Month 30 Day
Date trial data considered complete
2018 Year 01 Month 31 Day
Date analysis concluded
2018 Year 01 Month 31 Day

Other
Other related information At baseline, no demographic or health status factors were found to be different between the two groups.

Management information
Registered date
2016 Year 08 Month 24 Day
Last modified on
2019 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027362