UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008648 |
|---|---|
| Receipt number | 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 15:30:50 |
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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
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
fujino-t@boocsclinic.com
Sponsor or person
Institute
Fukuoka Seishukai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010122
