UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037178 |
|---|---|
| Receipt number | 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 | 2023/06/29 12:09:12 |
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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
onda2eiyoh@juno.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Koshimoto |
Organization
Tokyo Kasei Gakuin University
Division name
Faculty of Human Nutrition
Zip code
102-8341
Address
Japan
TEL
+81-3-3262-2251
Homepage URL
skoshimoto-rd@umin.ac.jp
Sponsor or person
Institute
Onda 2th Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Kasei Gakuin 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
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
DOI: 10.1177/00207640231174366
Publication of results
Published
Result
URL related to results and publications
DOI: 10.1177/00207640231174366
Number of participants that the trial has enrolled
93
Results
Ninety-three patients completed the study. The nutritional status and need for nutritional counseling in psychiatry patients indicates that patients with dietary problems requested nutritional counseling (p < .001). Patients who were more likely to need nutritional counseling had lower QOL in daily life (p = .011), pain/discomfort (p = .024), and anxiety/depression (p = .010) on the EuroQol 5-Dimension 5-level (EQ-5D-5L).
Results date posted
| 2023 | Year | 06 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eligible patients were asked to complete a questionnaire regarding physical measurements and nutritional counseling. In addition, patients' diagnoses and blood test data were referenced from their medical records. The analysis focused on two groups: those who desired to consult a nutritionist and those who did not.
Participant flow
Eligible patients were asked to complete a questionnaire regarding physical measurements and nutritional counseling. In addition, patients' diagnoses and blood test data were referenced from their medical records. The analysis focused on two groups: those who desired to consult a nutritionist and those who did not.
Adverse events
None.
Outcome measures
EuroQol 5-Dimension 5-level (EQ-5D-5L)
Hospital Anxiety Depression Scale(HADS)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2023 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042366
