UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004049 |
|---|---|
| Receipt number | R000004880 |
| Scientific Title | Community-based lifestyle education program for type 2 diabetes patients: a cluster randomized trial |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2016/04/02 11:53:28 |
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Basic information
Public title
Community-based lifestyle education program for type 2 diabetes patients: a cluster randomized trial
Acronym
Community-based lifestyle education program for type 2 diabetes patients: a cluster randomized trial
Scientific Title
Community-based lifestyle education program for type 2 diabetes patients: a cluster randomized trial
Scientific Title:Acronym
Community-based lifestyle education program for type 2 diabetes patients: a cluster randomized trial
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectness of the lifestyle education program by registered dietitians for type 2 diabetes patients in clinics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
Key secondary outcomes
BMI,FBS,LDL,HDL,TG,SBP/DBP,waist circumference,dietary intake(energy,%fat),health behavior
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
To conduct 6 months personal lifestyle education.
Interventions/Control_2
Usual care and show the result of the food frequency questionnaire.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients in clinic
2.HbA1c 6.1% over
3.For those who take diabetes medication or insulin,change rate of HbA1c should be less than 0.5% in last 3 months.
Key exclusion criteria
1.Proliferative retinopathy
2.Stage 3 nephropathy
3.Pregnant
4.Patient judged by doctor to have difficulty in writing investigation sheets.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Misa Adachi |
Organization
National Institute of Public Health
Doctoral course
Division name
Department of Technology Assessment and Biostatistics
Zip code
Address
2-3-6,Minami,Wako city,Saitama,Japan
TEL
048-458-6223
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Misa Adachi |
Organization
Nutrition Support Network LLC
Division name
Research & Development Dept
Zip code
Address
2-2-4,Wakamatsu,Sagamihara city,Kanagawa,Japan
TEL
Homepage URL
Sponsor or person
Institute
National Institute of Public Health
Institute
Department
Personal name
Funding Source
Organization
1.Ministry of Education,Culuture,Sports, Science and Technology,Grant-in-Aid for Scientific Research
2.Aid for scientific research of The Japan Dietetic Association
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2010 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
http://bmcpublichealth.biomedcentral.com/articles/10.1186/1471-2458-10-742
Publication of results
Published
Result
URL related to results and publications
http://bmcpublichealth.biomedcentral.com/articles/10.1186/1471-2458-13-467
Number of participants that the trial has enrolled
Results
The mean change at 6 months from baseline in HbA1c was a 0.7% decrease in the intervention group (n？=100) and a 0.2% decrease in the control group (n？=？93) (difference -0.5%, 95%CI: -0.2% to -0.8%, p？=？0.004). After adjusting for baseline values and other factors, the difference was still significant (p？=？0.003 to 0.011). The intervention group had a significantly greater decrease in mean energy intake at dinner compared with the control group and a greater increase in mean vegetable intake for the whole day, breakfast, and lunch as shown in crude and adjusted models. A tendency toward improvement was observed in the other secondary endpoints but the improvement was not statistically significant. These results were confirmed by several sensitivity analyses.
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
| 2007 | Year | 05 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 16 | Day |
Last modified on
| 2016 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004880
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
