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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037178
Receipt No. R000042366
Scientific Title Relationship between nutritional status and the need for nutritional counselling in psychiatry patients
Date of disclosure of the study information 2019/06/30
Last modified on 2019/08/22

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Basic information
Public title Relationship between nutritional status and the need for nutritional counselling in psychiatry patients
Acronym Relationship between nutritional status and the need for nutritional counselling in psychiatry patients
Scientific Title Relationship between nutritional status and the need for nutritional counselling in psychiatry patients
Scientific Title:Acronym Relationship between nutritional status and the need for nutritional counselling in psychiatry patients
Region
Japan

Condition
Condition Psychiatry patients
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aims of this study are to
1) explore the factors associated with nutritional status and QOL
2) examine the need for nutritional counseling in psychiatry patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Quality of Life score : EQ-5D
(EuroQol 5 Dimension)
Key secondary outcomes 1. Nutritional status : NNP(Nutirional status and need for nutritional couselling in psychiatry patients)
2. Psychological symptom : HADS(Hospital Anxiety and Depression Scale)

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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients are willful participants who have submitted informed consent in writing.
2) Patients are either currently admitted to or receiving outpatient care from the Onda 2nd Hospital.
3) Patients have received their primary physician's approval.
4) Healthy subjects participating in control group have submitted informed consent via anonymous questionnaire.
Key exclusion criteria 1) Those determined to be unable to participate by their primary physician due to physical or mental reasons.
2) Those who have a serious cognition disorder or mental disease.
Target sample size 240

Research contact person
Name of lead principal investigator
1st name Nanae
Middle name
Last name Kuboki
Organization Onda 2th Hospital
Division name Section of clinical nutrition
Zip code 270-2251
Address 302 Kanagasaku, Matudo-shi, Chiba-ken, Japan
TEL +81-47-387-3761
Email onda2eiyoh@juno.ocn.ne.jp

Public contact
Name of contact person
1st name Saori
Middle name
Last name Koshimoto
Organization Tokiwa University
Division name Faculty of Human science
Zip code 310-8585
Address Japan
TEL +81-29-232-2511
Homepage URL
Email skoshimoto-rd@umin.ac.jp

Sponsor
Institute Onda 2th Hospital
Institute
Department

Funding Source
Organization Tokiwa University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Onda 2th Hospital
Address 302 Kanagasaku, Matudo-shi, Chiba-ken, Japan
Tel +81-47-387-3761
Email onda2jim@aurora.ocn.ne.jp

Secondary IDs
Secondary IDs YES
Study ID_1 onR-0005
Org. issuing International ID_1 Onda 2th Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 恩田第二病院

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 30 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
2019 Year 06 Month 30 Day
Date of IRB
2016 Year 06 Month 10 Day
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1) Anthropometry
2) Questionnaire(EQ-5D,HADS,NNR)
3) Medical record


Management information
Registered date
2019 Year 06 Month 26 Day
Last modified on
2019 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042366

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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