UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006803 |
|---|---|
| Receipt number | R000008052 |
| Scientific Title | Development and validation of effective treatments of weight loss and weight-loss maintenance using cognitive behavioral therapy for obese patients. |
| Date of disclosure of the study information | 2012/01/01 |
| Last modified on | 2016/12/03 11:16:10 |
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Basic information
Public title
Development and validation of effective treatments of weight loss and
weight-loss maintenance using cognitive behavioral therapy for obese
patients.
Acronym
Development and validation of effective treatments of weight loss and
weight-loss maintenance using cognitive behavioral therapy for obese
patients.
Scientific Title
Development and validation of effective treatments of weight loss and
weight-loss maintenance using cognitive behavioral therapy for obese
patients.
Scientific Title:Acronym
Development and validation of effective treatments of weight loss and
weight-loss maintenance using cognitive behavioral therapy for obese
patients.
Region
| Japan |
Condition
Condition
obesity
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate an efficient treatment for prevending weight regain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body change at the end of the intervention and 2-years follow-up periods.
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
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Multidisciplinary cognitive behavioral therapy in the weight maintenance phase(therapy which is forcused on the enhance of the adehrence to exercise)
Interventions/Control_2
Booster cognitive behavioral therapy in the weight maintenance phase(therapy which is mainly composed of the review of the weight loss therapy)
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
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Womnan aged 20 to 65 years old
2.25<=BMI<45
3.Woman who can fulfill questionnaire by herself
4.Woman who can do brief mat exercise
Key exclusion criteria
1.Weight loss over 5kg in the past 6 months
2.Bulimia nervosa
3.Anorexia nervosa
4.Pregnant or breast feeding woman or planning to be pregant in the following 2 years
5.Takin medicine or suppliment which can affect body weight
6.Having deseases which can affect body weight ,such as cancer or endocrine diseases
7.Recieving treatment for OSAS
8.Recieving treatment for mental diseases
9.Planning to move in the following 10 months
Target sample size
106
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Sudo |
Organization
Kyushu University
Division name
Psychosomatic medicine
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka,Japan
TEL
092-642-5323
nobuyuki@med.kyusyu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoko Sawamoto |
Organization
Kyushu University
Division name
Psychosomatic medicine
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka,Japan
TEL
092-642-5323
Homepage URL
rsawamoto3286@gmail.com
Sponsor or person
Institute
Department of Psychosmatic medicine,Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 01 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 03 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 30 | Day |
Last modified on
| 2016 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008052
| Research Plan | |
|---|---|
| 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 |
