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

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 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


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

Value
https://center6.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