UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030444 |
|---|---|
| Receipt number | R000034741 |
| Scientific Title | Effects of a mindfulness-based intervention versus cognitive behavioral therapy on weight loss and weight maintenance for women with overweight or obesity: a randomized controlled trial. |
| Date of disclosure of the study information | 2017/12/19 |
| Last modified on | 2024/02/29 21:51:36 |
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Basic information
Public title
Effects of a mindfulness-based intervention versus cognitive behavioral therapy on weight loss and weight maintenance for women with overweight or obesity: a randomized controlled trial.
Acronym
Effects of mindfulness compared with cognitive behavioral therapy for obesity: a randomized controlled trial.
Scientific Title
Effects of a mindfulness-based intervention versus cognitive behavioral therapy on weight loss and weight maintenance for women with overweight or obesity: a randomized controlled trial.
Scientific Title:Acronym
Effects of mindfulness compared with cognitive behavioral therapy for obesity: a randomized controlled trial.
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of mindfulness compared with cognitive behavioral therapy on weight loss and long-term weight maintenance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To examine superiority effect of mindfulness
over cognitive behavioral therapy in 2-years weight maintenance after weight loss intervention.
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
34-week weight loss intervention including mindfulness-based stress management
Interventions/Control_2
34-week weight loss intervention including cognitive behavioral therapy-based stress management
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
| 25 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
The study population consists of female participants with obesity and overweight (27<=BMI<40) who are recruited using website and publications, who can complete questionnaires concerning the study and give informed written consent.
Key exclusion criteria
We exclude those subjects who have loosed more than 5kg within recent half year, pregnant or breast-feeding women, have schedule of pregnancy within 2 years, were taking any medication or supplement that might affect weight or taste, diagnosed as bulimia nervosa, a history of anorexia nervosa, taste disorders, a history of sinusitis and presenting sinus problem, presented such illness that may affect weight as malignancy or endocrine disease, have been during obstructive sleep apnea syndrome(OSAS)or psychiatry disease treatment, have schedule of move during the research period(8 months), and those who are judged inadequate by responsible doctor for any reason.
Target sample size
112
Research contact person
Name of lead principal investigator
| 1st name | Takehiro |
| Middle name | |
| Last name | Nozaki |
Organization
Kyushu University
Division name
Department of Psychosomatic medicine
Zip code
8128582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka city, Fukuoka, Japan
TEL
0926425318
takano.hidemi.688@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takehiro |
| Middle name | |
| Last name | Nozaki |
Organization
Kyushu University
Division name
Department of Psychosomatic medicine
Zip code
8128582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka city, Fukuoka, Japan
TEL
092-642-5318
Homepage URL
takano.hidemi.688@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University ARO center
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-citu, Fukuoka
Tel
0926426290
tr-info@med.kyushu-u.ac.jp
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
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 19 | 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
| 2017 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 18 | Day |
Last modified on
| 2024 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034741
