UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041826 |
|---|---|
| Receipt number | R000047725 |
| Scientific Title | Effects of preoperative emotional eating on body weight after bariatric surgery |
| Date of disclosure of the study information | 2020/09/23 |
| Last modified on | 2020/12/01 13:51:13 |
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Basic information
Public title
Effects of preoperative emotional eating on body weight after bariatric surgery
Acronym
Effects of preoperative emotional eating on body weight after bariatric surgery
Scientific Title
Effects of preoperative emotional eating on body weight after bariatric surgery
Scientific Title:Acronym
Effects of preoperative emotional eating on body weight after bariatric surgery
Region
| Japan |
Condition
Condition
obesity
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Psychosomatic Internal Medicine |
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effects of preoperative emotional eating on body weight after bariatric surgery
Basic objectives2
Others
Basic objectives -Others
To identify psychosocial factors affecting preoperative emotional eating
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess whether preoperative emotional eating predicts postoperative weight change (percent excess weight loss) during the 2 years of follow-up period
Key secondary outcomes
To identify psychosocial factors affecting preoperative emotional eating
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Male and Female
Key inclusion criteria
(1)Patiens visiting the surgery clinic of Kyushu University Hospital, meeting the eligibility criteria for bariatric surgery (listed below).
(2)Patients that are able to understand the study protocol, and participate with informed concent.
(3)Patients over the age of 20 when informed concent is given.
Eligibility Criteria for Bariatric Surgery:
1)Patients aged 20 to 65 years with primary obesity
2)Inability to achieve significant weight loss or no improvement of obesity-related comorbidities despite more than 6 months of conservative treatments, and
i. For bariatric surgery (mainly to lose weight), BMI>= 35
ii. For metabolic surgery (mainly to treat obesity-related comorbidities such as diabetes, hypertension, dyslipidemia, liver dysfunction, sleep apnea syndrome etc.), BMI>=32 with diabetes or two or more comorbidities other than diabetes.
Key exclusion criteria
(1)Poorly controlled psychiatric illness such as depression, bipolar disorder, schizophrenia, alcohol abuse and/or drug dependency
(2)Multiple suicide attempts or recent suicide attempt
(3)Severe intellectual disabilities
(4)Patients that the researcher judged to be inappropriate as a research subject
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takehiro |
| Middle name | |
| Last name | Nozaki |
Organization
Kyushu University
Division name
Psychosomatic Medicine
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5318
nozaki.takehiro.466@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Yokoyama |
Organization
Kyushu University
Division name
Psychosomatic Medicine
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5318
Homepage URL
yokoyama.hiroaki.211@s.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Psychosomatic Medicine, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Department of Psychosomatic Medicine, Kyushu University
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
Institutional Review Board of Kyushu University
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
Tel
092-642-6772
ijkseimei@jimu.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To clarify the effect of preoperative emotional eating of bariatric patients on postoperative weight, and to identify psychosocial factors affecting preoperative emotional eating, we will obtain and assess anthropometric data and psychosocial factors at baseline, 3, 6, 12, 18, 24 months after surgery.
Management information
Registered date
| 2020 | Year | 09 | Month | 17 | Day |
Last modified on
| 2020 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047725
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
