UMIN-CTR Clinical Trial

Basic information
Public title	Dietary guidance and walking exercise therapy for patients with psychotic disorders: an open-label study
Acronym	Dietary guidance and walking exercise therapy for patients with psychotic disorders: an open-label study
Scientific Title	Dietary guidance and walking exercise therapy for patients with psychotic disorders
Scientific Title:Acronym	Dietary guidance and walking exercise therapy for patients with psychotic disorders
Region	Japan

Condition
Condition	Psychotic disorders
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Dietary guidance and walking exercise therapy for patients with psychotic disorders
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Weight and body composition measurement (InBody470)
Key secondary outcomes	Clinical Global Impressions - severity of illness

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
Interventions/Control_1	Dietary guidance/Walking exercise therapy
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. patients who, after receiving full explanation and with full understanding, give written consent of their own free will to participate in this study 2. patients who are between 20 and 65 years of age at the time of consent 3. patients with clinically stable psychiatric symptoms 4. patients who are capable of performing walking exercise therapy (10,000 steps/day, at least 5 days/week) 5. patients with BMI >25
Key exclusion criteria	1. patients with serious physical illnesses 2. pregnant, lactating or planning to become pregnant 3. patients with blood pressure that is not stabilized due to hypertension of the third degree (blood pressure of 180/100 mg HG or higher) 4. patients with a history of cerebrovascular disease or with signs and symptoms that suggest such a disease 5. patients with suicidal ideation or suicidal attempts 6. patients with signs and symptoms of acute inflammation of the musculoskeletal system in the locomotor area 7. patients with diabetes mellitus 8. other patients who are deemed inappropriate by the Principal Investigator or Principal Investigator
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kishi Middle name Last name Taro
Organization	Fujita Health University School of Medicine
Division name	Psychiatry
Zip code	470-1192
Address	1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
TEL	0562939250
Email	tarok@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Kishi Middle name Last name Taro
Organization	Fujita Health University School of Medicine
Division name	Psychiatry
Zip code	470-1192
Address	1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
TEL	0562939250
Homepage URL
Email	tarok@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization	Fujita Health University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fujita Health University School of Medicine
Address	1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
Tel	0562-93-2865
Email	f-irb@fujita-hu.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	2022 Year 07 Month 22 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	21
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	Completed
Date of protocol fixation	2021 Year 02 Month 09 Day
Date of IRB	2021 Year 02 Month 09 Day
Anticipated trial start date	2021 Year 02 Month 09 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 07 Month 22 Day
Last modified on	2022 Year 07 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055197