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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001259
Receipt No. R000001520
Scientific Title Effects of weight-loss tools and a group-based weight-loss support program: A randomized controlled trial
Date of disclosure of the study information 2008/07/24
Last modified on 2018/06/09

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Basic information
Public title Effects of weight-loss tools and a group-based weight-loss support program: A randomized controlled trial
Acronym Effects of weight-loss tools and a group-based weight-loss support program
Scientific Title Effects of weight-loss tools and a group-based weight-loss support program: A randomized controlled trial
Scientific Title:Acronym Effects of weight-loss tools and a group-based weight-loss support program
Region
Japan

Condition
Condition Obesity
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of weight-loss tools and a group-based weight-loss support program
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 -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 A single motivational lecture on weight loss
Interventions/Control_2 A single motivational lecture on weight loss and provision of weight-loss tools
Interventions/Control_3 A single motivational lecture on weight loss, provision of weight-loss tools, and a 6-month group-based weight-loss support program (8 times in a 6-month period)
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 conditions.
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 for diabetes
Past history of coronary disease
Past history of stroke
Current or planned pregnancy
Participation in a weight-loss program during the previous 6 months
Having participated of one's family living together in this study
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Nakata
Organization University of Tsukuba
Division name Graduate School of Comprehensive Human Sciences
Zip code
Address 1-1-1 Tennodai, Tsukuba
TEL 029-853-3076
Email

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

Sponsor
Institute Course of life-style related disorders donated by JA Ibaraki Public Welfare Federation
Institute
Department

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

Other related organizations
Co-sponsor Mito Kyodo General Hospital
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 水戸協同病院(茨城県)

Other administrative information
Date of disclosure of the study information
2008 Year 07 Month 24 Day

Related information
URL releasing protocol http://www.ncbi.nlm.nih.gov/pubmed/21061562
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/25428509
Number of participants that the trial has enrolled
Results
The 6-month randomised controlled trial provides evidence that using educational materials and group-based support is effective components of weight-loss program. 
The effects of group-based support disappear within 2 years. Increasing physical activity may be crucial factor for successful maintenance of weight loss.
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
2008 Year 07 Month 04 Day
Date of IRB
Anticipated trial start date
2008 Year 11 Month 01 Day
Last follow-up date
2011 Year 10 Month 01 Day
Date of closure to data entry
2012 Year 03 Month 01 Day
Date trial data considered complete
2012 Year 09 Month 01 Day
Date analysis concluded
2013 Year 03 Month 01 Day

Other
Other related information Nippon Koshu Eisei Zasshi 57(9): 835-842, 2010.
Obesity Facts 4(3): 222-228, 2011.
Obesity Facts 7(6): 376-387, 2014.

Management information
Registered date
2008 Year 07 Month 22 Day
Last modified on
2018 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001520

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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