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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004049
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute National Institute of Public Health
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004880

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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