UMIN-CTR Clinical Trial

Basic information
Public title	Development of a lifestyle improvement program for people with schizophrenia with cognitive dysfunction living in the community
Acronym	Development of a lifestyle improvement program for people with schizophrenia with cognitive dysfunction living in the community
Scientific Title	Development of a lifestyle improvement program for people with schizophrenia with cognitive dysfunction living in the community
Scientific Title:Acronym	Development of a lifestyle improvement program for people with schizophrenia with cognitive dysfunction living in the community
Region	Japan

Condition
Condition	schizophrenia and schizoaffective disorder
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To construct a lifestyle improvement program for people with schizophrenia with cognitive dysfunction in the community
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Various measured values (weight, BMI, body fat percentage, waist circumference, blood pressure)
Key secondary outcomes	Health habits, social function, spontaneity, self-efficacy, neurocognitive function

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	16 weeks health consultation (1 hour once a week, once a week) and cognitive training (1 hour once a day, 5 days a week)
Interventions/Control_2	16 weeks health consultation (1 hour once a week, once a week)only
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	45 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Underwent a diagnosis of schizophrenia or schizoaffective disorder in the community (2) Men and women from 40 to 65 (3) People who are obese or overweight (4) Cognitive dysfunction (MoCA-J 26 points or less) (5) More than 2 years have passed since diagnosis of schizophrenia or schizoaffective disorder, and both mind and body are stable (6) Who have been attending to social rehab facility for more than three months
Key exclusion criteria	(1) There is no head injury and no organic disease of the brain (2) No inappropriate use of alcohol or drug within 6 months before intervention
Target sample size	50

Research contact person
Name of lead principal investigator	1st name yoshiko Middle name Last name FUJIMORI
Organization	Wakayama medical university
Division name	School of Health and Nursing Science
Zip code	641-0011
Address	Wakayama city, Mikazura 580
TEL	0734466723
Email	fujimori@wakayama-med.ac.jp

Public contact
Name of contact person	1st name yoshiko Middle name Last name FUJIMORI
Organization	Wakayama medical university
Division name	School of Health and Nursing Science
Zip code	641-0011
Address	Wakayama city, Mikazura 580
TEL	0734466723
Homepage URL
Email	fujimori@wakayama-med.ac.jp

Sponsor
Institute	Wakayama medical university
Institute
Department

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	Kobe City College of Nursing
Address	Kobe City, Nishi Ward, Gakuen Nishimachi, 4-3
Tel	078-794-8080
Email	mail@kobe-ccn.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	2019 Year 07 Month 07 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	2019 Year 01 Month 15 Day
Date of IRB	2019 Year 01 Month 22 Day
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2020 Year 10 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	2019 Year 07 Month 03 Day
Last modified on	2019 Year 07 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042409