UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of weight loss program using Healthy Plate at pharmacy/Cluster randomized controlled trial
Acronym	Efficacy of weight loss program using Healthy Plate at pharmacy
Scientific Title	Efficacy of weight loss program using Healthy Plate at pharmacy/Cluster randomized controlled trial
Scientific Title:Acronym	Efficacy of weight loss program using Healthy Plate at pharmacy
Region	Japan

Condition
Condition	Overweight
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Support for improvement of obesity is consistent with actively supporting self supporting health promotion and promotion by citizens of functions required of health support pharmacies. We clarify the effectiveness of weight loss program using Healthy Plate at pharmacy and verify whether pharmacy can support improvement of obesity.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Body weight after 12 weeks Body mass index after 12 weeks
Key secondary outcomes	Blood pressure after 12 weeks Waist circumference after 12 weeks Body composition after 12 weeks Dietary tendency after 12 weeks

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Placebo
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	Intervention group conducts diet education once with health plate. Follow up the course over 3 months after intervention.
Interventions/Control_2	Control group with diet education without using healthy plate. Follow up the course over 3 months after diet education.
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	Adults with BMI 25 or more
Key exclusion criteria	Exclude when the following conditions are satisfied. 1) diabetes based on insulin therapy and GLP-1 drug, 2) dementia 3) chronic renal failure
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name koyama yoshiaki
Organization	Generalincorporated association social University
Division name	Generalincorporated association social University
Zip code
Address	8-5-26 Akasaka Minato-ku, Tokyo Sumitomo Realty Aoyama Building West Building 4F
TEL	03-5413-8922
Email	koyama3347@yakuju.co.jp

Public contact
Name of contact person	1st name Middle name Last name koyama yoshiaki
Organization	Generalincorporated association social University
Division name	Generalincorporated association social University
Zip code
Address	8-5-26 Akasaka Minato-ku, Tokyo Sumitomo Realty Aoyama Building West Building 4F
TEL	03-5413-8922
Homepage URL
Email	koyama3347@yakuju.co.jp

Sponsor
Institute	Generalincorporated association social University
Institute
Department

Funding Source
Organization	Generalincorporated association social University
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
Address
Tel
Email

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	2017 Year 09 Month 16 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	Open public recruiting
Date of protocol fixation	2017 Year 07 Month 25 Day
Date of IRB	2017 Year 06 Month 21 Day
Anticipated trial start date	2017 Year 08 Month 16 Day
Last follow-up date	2018 Year 05 Month 31 Day
Date of closure to data entry	2018 Year 05 Month 31 Day
Date trial data considered complete	2018 Year 06 Month 30 Day
Date analysis concluded	2018 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 09 Month 11 Day
Last modified on	2019 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033274