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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029094
Receipt No. R000033274
Scientific Title Efficacy of weight loss program using Healthy Plate at pharmacy/Cluster randomized controlled trial
Date of disclosure of the study information 2017/09/16
Last modified on 2018/03/19

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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
Anticipated trial start date
2017 Year 08 Month 16 Day
Last follow-up date
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
2018 Year 03 Month 19 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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