UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001259 |
|---|---|
| Receipt number | 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 09:14:47 |
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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
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
nakata@md.tsukuba.ac.jp
Sponsor or person
Institute
Course of life-style related disorders donated by JA Ibaraki Public Welfare Federation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001520
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
