UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intervention program by health promotion volunteer for improving food variety in old age
Title of the study (Brief title)	Intervention program by health promotion volunteer for improving food variety in old age
Region	Japan

Condition
Condition	Food variety
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of an intervention program by health promotion volunteer to improve food variety for older people
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Food variety score
Key secondary outcomes	Dietary-related QOL

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	Lecture of the importance of food variety by health promotion volunteer (four sessions) Group work by participants and health promotion volunteer
Interventions/Control_2	No intervention
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	65 years-old <=
Age-upper limit	74 years-old >=
Gender	Male and Female
Key inclusion criteria	Less than 3 points in food variety score
Key exclusion criteria	More than 4 points in food variety score
Target sample size	50

Research contact person
Name of lead principal investigator	Atsuko Taguchi
Organization	Tohoku University
Division name	Graduate School of Medicine
Address	2-1 Seiryo-machi, Aobak-ku, Sendai, Miyagi, 980-8575, Japan
TEL	022-717-7922
Email	ataguchi@med.tohoku.ac.jp

Public contact
Name of contact person	Atsuko Taguchi
Organization	Tohoku University
Division name	Graduate School of Medicine
Address	2-1 Seiryo-machi, Aobak-ku, Sendai, Miyagi, 980-8575, Japan
TEL	022-717-7922
Homepage URL
Email	ataguchi@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Pfizer Health Research Foundation Mitsubishi Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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	2014 Year 12 Month 15 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 08 Month 30 Day
Anticipated trial start date	2014 Year 09 Month 01 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry	2016 Year 01 Month 31 Day
Date trial data considered complete	2016 Year 01 Month 31 Day
Date analysis concluded	2016 Year 07 Month 31 Day

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

Management information
Registered date	2014 Year 12 Month 15 Day
Last modified on	2016 Year 08 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018563