UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development and validation of effective treatments of weight loss and weight-loss maintenance using cognitive behavioral therapy for obese patients.
Title of the study (Brief title)	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	Nobuyuki Sudo
Organization	Kyushu University
Division name	Psychosomatic medicine
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka,Japan
TEL	092-642-5323
Email	nobuyuki@med.kyusyu-u.ac.jp

Public contact
Name of contact person	Ryoko Sawamoto
Organization	Kyushu University
Division name	Psychosomatic medicine
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka,Japan
TEL	092-642-5323
Homepage URL
Email	rsawamoto3286@gmail.com

Sponsor
Institute	Department of Psychosmatic medicine,Kyushu University
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 10 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008052