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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029664
Receipt No. R000033896
Scientific Title The pilot study of Cognitive Behavioral Therapy with Mindfulness and an Internet Intervention for obesity
Date of disclosure of the study information 2017/10/30
Last modified on 2017/10/23

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Basic information
Public title The pilot study of Cognitive Behavioral Therapy with Mindfulness and an Internet Intervention for obesity
Acronym The pilot study of Cognitive Behavioral Therapy with Mindfulness and an Internet Intervention for obesity
Scientific Title The pilot study of Cognitive Behavioral Therapy with Mindfulness and an Internet Intervention for obesity
Scientific Title:Acronym 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
1st name
Middle name
Last name Keizaburo Ogata
Organization Kitasato University East Hospital
Division name Psychotherapy Department
Zip code
Address 2-1-1, Asamizodai, Minami-ku, Sagamihara-city, Kanagawa
TEL 042-748-9111
Email kzaburo@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Akio Inui
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Department of Psychosomatic Internal Medicine
Zip code
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)

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
2017 Year 10 Month 30 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
2017 Year 10 Month 23 Day
Date of IRB
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

Other
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

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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