UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021868 |
|---|---|
| Receipt number | 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 09:53:36 |
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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
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
h-takano@cephal.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Psyshosomatic medicine, Kyushu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025216
