UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029664 |
|---|---|
| Receipt number | 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 00:22:22 |
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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
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
inui@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033896
