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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010505
Receipt No. R000012150
Scientific Title Effects of motivational lecture in promoting weight loss: A randomized controlled trial
Date of disclosure of the study information 2013/04/16
Last modified on 2014/10/16

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Basic information
Public title Effects of motivational lecture in promoting weight loss: A randomized controlled trial
Acronym Effects of motivational lecture on weight loss
Scientific Title Effects of motivational lecture in promoting weight loss: A randomized controlled trial
Scientific Title:Acronym Effects of motivational lecture on weight loss
Region
Japan

Condition
Condition Obesity
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of motivational lecture in promoting weight loss
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Body weight
Key secondary outcomes Waist circumference
Systolic blood pressure
Diastolic blood pressure
Triglycerides
High-density lipoprotein cholesterol
Fasting plasma glucose

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 No intervention
Interventions/Control_2 A single motivational lecture on weight loss
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
40 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria A body mass index is 25 or more but less than 40, and the presence of at least one of the following components.
1. Waist circumference 85cm or more in males and 90cm or more in females
2. Systolic blood pressure 130mmHg or more
3. Diastolic blood pressure 85mmHg or more
4. Triglycerides level 150mg/dL or more
5. High-density lipoprotein cholesterol level less than 40mg/dL
6. Fasting plasma glucose level 110mg/dL or more
Key exclusion criteria Drug treatment of diabetes
Past hisory of coronary disease
Past history of stroke
Current or planned pregnancy
Participation in a weight-loss program during the last 6 months
Having cohabiting family member participated in this study
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Nakata
Organization University of Tsukuba
Division name Faculty of Medicine
Zip code
Address 1-1-1 Tennodai, Tsukuba
TEL 029-853-3076
Email nakata@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshio Nakata
Organization University of Tsukuba
Division name Faculty of Medicine
Zip code
Address 1-1-1 Tennodai, Tsukuba
TEL 029-853-3076
Homepage URL
Email nakata@md.tsukuba.ac.jp

Sponsor
Institute Course of clinical research and regional innovation donated by the Japan Agriculture Ibaraki Public Welfare Federation
Institute
Department

Funding Source
Organization Japan Agriculture Ibaraki Public Welfare Federation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 筑波大学医学医療系(茨城県)

Other administrative information
Date of disclosure of the study information
2013 Year 04 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 Completed
Date of protocol fixation
2013 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 02 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 09 Month 30 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 04 Month 16 Day
Last modified on
2014 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012150

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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