UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intervention and evaluation of education program for dietary change in COPD patients
Title of the study (Brief title)	Intervention and evaluation of program for dietary change in COPD patients
Region	Japan

Condition
Condition	COPD
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to construct, practice, and evaluate the effect of the education program for dietary change in COPD patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Anthropometric outcome (height, weight, upper arm muscle circumference, triceps part subcutaneous fat thickness) Assessing at baseline and 12-18 weeks later.
Key secondary outcomes	Knowledge and ingenuity of dietary intake method and nutritional intake

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	The individual intervention is to educate the support program. At 4-6 weeks later we support patients against influence factors. At 8-12 weeks later we support patients to acquire skills related to behavior. At 10-15 weeks later we support patients to continue dietary change. First and second intervention consists of interview for about one hour and final intervention consists of interview by telephone for about ten minutes.
Interventions/Control_2	Control group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	COPD patients
Key exclusion criteria	Exacerbation within one month Obesity (BMI>25) Cognitive impairment Oral antipsychotic drugs Malignant diseases Endocrinological diseases Gastrointestinal diseases
Target sample size	20

Research contact person
Name of lead principal investigator	Taichiro Arimoto
Organization	Kyoto Prefectural University of Medicine
Division name	Pulmonary Medicine
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566
TEL	075-251-5513
Email	arimt@koto.kpu-m.ac.jp

Public contact
Name of contact person	Takako Mouri
Organization	Osaka Prefecture University
Division name	Graduate School of Nursing
Address	3-7-30, Habikino, Habikino-Shi, Osaka 583-8555
TEL	0729-50-2111
Homepage URL
Email	dw601004@edu.osakafu-u.ac.jp

Sponsor
Institute	Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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

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	2015 Year 10 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 08 Month 11 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 09 Month 08 Day
Last modified on	2016 Year 07 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021910