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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021868
Receipt No. R000025216
Scientific Title The association between taste perception and sleep parameters in female patients with obesity and their changes after weight loss intervention using a group cognitive behavioral therapy.
Date of disclosure of the study information 2016/04/12
Last modified on 2018/11/07

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Basic information
Public title The association between taste perception and sleep parameters in female patients with obesity and their changes after weight loss intervention using a group cognitive behavioral therapy.
Acronym Taste perception change in weight loss intervention for obese patients
Scientific Title The association between taste perception and sleep parameters in female patients with obesity and their changes after weight loss intervention using a group cognitive behavioral therapy.
Scientific Title:Acronym Taste perception change in weight loss intervention for obese patients
Region
Japan

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

Objectives
Narrative objectives1 To investigate the association between taste perception and sleep parameters in obese patients and their changes after weight loss.
Basic objectives2 Others
Basic objectives -Others To investigate the association of serum satiety hormons, psychological variables and taste change.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The association between changes in taste perception/preference and sleep parameters by weight loss treatment.
Key secondary outcomes The association between baseline taste perception and sleep parameters.
The prediction of the effect of baseline taste perception on weight loss.

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 Participants receive a six-month weight loss intervention and a one-month weight maintenance treatment using a group cognitive behavioral therapy (CBT). Each group consists of 10-12 participants who take a 90-min session at weekly intervals (total 30 sessions). We modified the CBT of Cooper&Fairburn for a group therapy program that included clinical guidelines on obesity of National Institute of Health (NIH) and Diabetes Prevention Program (DPP). The weight maintenance program focuses on preventing regaining the lost weight. Following the completion of the treatment, semi-annual follow-up meetings are hold twice.
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
20 years-old <=
Age-upper limit
65 years-old >
Gender Female
Key inclusion criteria The study population consists of female participants with obesity (25<=BMI<40) and healthy controls (19<=BMI<=24) who are recruited using website and publications.
Key exclusion criteria We exclude those subjects who have taste disorders, a history of sinusitis and presenting sinus problem, loosed more than 5kg within recent half year, diagnosed as bulimia nervosa, a history of anorexia nervosa, pregnant or breast-feeding women, those who have schedule of pregnancy within 2 years, taken any medication or supplement that might affect weight or taste, presented such illness that may affect weight as malignancy or endocrine disease, been during obstructive sleep apnea syndrome (OSAS) or psychiatry disease treatment, and schedule of move during the research period (7 months).
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Sudo
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
Email h-takano@cephal.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyuki Sudo
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 Department of Psyshosomatic medicine, Kyushu University
Institute
Department

Funding Source
Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 12 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 No longer recruiting
Date of protocol fixation
2015 Year 11 Month 09 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 01 Day
Last follow-up date
2017 Year 08 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 11 Day
Last modified on
2018 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025216

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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