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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030444
Receipt No. 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 2018/12/27

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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
Middle name
Last name Takehiro Nozaki
Organization Kyushu University
Division name Department of Psychosomatic medicine
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka city, Fukuoka, Japan
TEL 0926425318
Email h-takano@cephal.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takehiro Nozaki
Organization Kyushu University
Division name Department of Psychosomatic medicine
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka city, Fukuoka, Japan
TEL 092-642-5318
Homepage URL
Email h-takano@cephal.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Self funding
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 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
Anticipated trial start date
2017 Year 12 Month 16 Day
Last follow-up date
2022 Year 08 Month 31 Day
Date of closure to data entry
2023 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
2018 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034741

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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