UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The pilot study of Cognitive Behavioral Therapy with Mindfulness and an Internet Intervention for obesity
Title of the study (Brief title)	The pilot study of Cognitive Behavioral Therapy with Mindfulness and an Internet Intervention for obesity
Region	Japan

Condition
Condition	Obesity
Classification by specialty	Psychosomatic Internal Medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this trial is to examine the effectiveness of a new cognitive behavioral therapy program that combines mindfulness exercises and an online intervention to prevent dropout and subsequent weight gain in overweight participants.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Body Mass Index
Key secondary outcomes	Dutch Eating Behavior Questionnaire State-Trait Anxiety Inventory Five Facet Mindfulness Questionnaire

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom Other
Interventions/Control_1	The diet program consisted of weekly 60-minute group sessions implemented for nine weeks. The program was divided into two sections. Specifically, during the first four weeks of the program, participants received only face-to-face therapy, and in the subsequent five weeks of the program, participants were required to upload their daily food intake and activities to an SNS page
Interventions/Control_2
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	18 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1 between 18 and 60 years of age 2 BMI between 25 and 40 3 previous lack of success in weight reduction programs 4 availability to participate in treatment for nine weeks 5 access to the Internet on a daily basis 6 willingness to participate in the study
Key exclusion criteria	1 consultation with a doctor for type 1 or 2 diabetes, cardiovascular disease, or mental health disorders 2 pregnancy 3 weight loss within the preceding six months because of weight loss success
Target sample size	10

Research contact person
Name of lead principal investigator	Keizaburo Ogata
Organization	Kitasato University East Hospital
Division name	Psychotherapy Department
Address	2-1-1, Asamizodai, Minami-ku, Sagamihara-city, Kanagawa
TEL	042-748-9111
Email	kzaburo@gmail.com

Public contact
Name of contact person	Akio Inui
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Department of Psychosomatic Internal Medicine
Address	8-35-1, Sakuragaoka, Kagoshima-city, Kagoshima
TEL	099-275-5751
Homepage URL
Email	inui@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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	2017 Year 10 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 23 Day
Anticipated trial start date	2017 Year 10 Month 30 Day
Last follow-up date
Date of closure to data entry
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	2017 Year 10 Month 23 Day
Last modified on	2017 Year 10 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033896