UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014428 |
|---|---|
| Receipt number | R000016793 |
| Scientific Title | Using a web-based intervention to promote weight loss maintenance: A randomized controlled trial |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2018/06/09 09:15:53 |
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Basic information
Public title
Using a web-based intervention to promote weight loss maintenance: A randomized controlled trial
Acronym
Web-based intervention for weight loss maintenance
Scientific Title
Using a web-based intervention to promote weight loss maintenance: A randomized controlled trial
Scientific Title:Acronym
Web-based intervention for weight loss maintenance
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the effects of web-based intervention in promoting weight loss maintenance
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 web-based weight loss maintenance program
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. Abdominal obesity: waist circumference 85 cm or more in males and 90 cm or more in females
2. Hyperglycemia: fasting plasma glucose level 100 mg/dL or more; HbA1c 5.6% or more; medication for diabetes mellitus
3. Dyslipidemia: triglycerides level 150 mg/dL or more; high-density lipoprotein cholesterol level less than 40 mg/dL; medication for dyslipidemia
4. Hypertension: systolic blood pressure 130 mmHg or more; diastolic blood pressure 85 mmHg or more; medication for hypertension
Key exclusion criteria
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
130
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
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
nakata@md.tsukuba.ac.jp
Sponsor or person
Institute
Course of clinical research and regional innovation donated by the Japan Agriculture Ibaraki Public Welfare Federation
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 01 | 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
| 2014 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 12 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 30 | 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=R000016793
