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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008648
Receipt No. R000010122
Scientific Title A New Eating-Behavior Modification Program (BOOCS) Improves Glycemic Control, Treatment Satisfaction and Emotional Distress in Patients With Mild Type 2 Diabetes – A Randomized Controlled Trial
Date of disclosure of the study information 2012/08/08
Last modified on 2012/08/08

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Basic information
Public title A New Eating-Behavior Modification Program (BOOCS) Improves Glycemic Control, Treatment Satisfaction and Emotional Distress in Patients With Mild Type 2 Diabetes – A Randomized Controlled Trial
Acronym BOOCS-program improves mild type 2 diabetes
Scientific Title A New Eating-Behavior Modification Program (BOOCS) Improves Glycemic Control, Treatment Satisfaction and Emotional Distress in Patients With Mild Type 2 Diabetes – A Randomized Controlled Trial
Scientific Title:Acronym BOOCS-program improves mild type 2 diabetes
Region
Japan

Condition
Condition type 2 Diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of a new eating-behavior modification program (BOOCS), on the glycemic control, treatment satisfaction and emotional distress of type 2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HbA1c, blood glucose, IRI,serum lipids, Body weight,DTSQ, PAID
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Sixty three out-patients with type 2 diabetes followed by diet therapy only (average HbA1c: 7.6%, BMI: 25.4kg/m2) were randomly divided into the standard-therapy group and BOOCS-therapy group, and were observed for one year. The standard-therapy group took a low caloric and restricted diet.
Interventions/Control_2 BOOCS-therapy group followed a non-restricted diet which aims to take pleasantness and satisfaction.
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
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (a) male or female, 30 years or older, (b) attending an education program on diabetes regarding the cause of the disease, process, complications, exercise therapy, and diet therapy by conventional calorie control, and visiting the hospital continuously for 6 months or more.
Key exclusion criteria (a) not receiving pharmacologic treatment, such as an oral hypoglycemic agent or insulin, and treatment for 8 weeks prior to the start of the trial has only been diet therapy, and (b) without unstable diabetes complications, alcohol addiction, or mental illness.
Target sample size 63

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takehiko Fujino
Organization BOOCS Medical Corporation
Division name Director
Zip code
Address 6-18-6F, Tenyamachi, Hakata-ku, Fukuoka-shi Fukuoka 812-0025 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization BOOCS Medical Corporation
Division name BOOCS Clinic Fukuoka
Zip code
Address 6-18-6F, Tenyamachi, Hakata-ku, Fukuoka-shi Fukuoka 812-0025 Japan
TEL 092-283-6852
Homepage URL
Email fujino-t@boocsclinic.com

Sponsor
Institute Fukuoka Seishukai Hospital
Institute
Department

Funding Source
Organization Fukuoka Seishukai Hospital
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
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
2012 Year 08 Month 08 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
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
2001 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2001 Year 02 Month 01 Day
Last follow-up date
2002 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 08 Month 08 Day
Last modified on
2012 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010122

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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