UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014529 |
|---|---|
| Receipt number | R000016901 |
| Scientific Title | Three-arm parallel randomised trial for the prevention of weight gain in young adults |
| Date of disclosure of the study information | 2014/07/10 |
| Last modified on | 2014/07/10 15:21:22 |
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Basic information
Public title
Three-arm parallel randomised trial for the prevention of weight gain in young adults
Acronym
Weigh-gain prevention in young adults.
Scientific Title
Three-arm parallel randomised trial for the prevention of weight gain in young adults
Scientific Title:Acronym
Weigh-gain prevention in young adults.
Region
| Europe |
Condition
Condition
weight gain prevention
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of an on-line intervention based on two behavioural models on preventing the weight gain observed during young adulthood.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevent weight gain in young adults over a 9-month period
Key secondary outcomes
Use of anilne resources and association with weight changes in order to define the 'right dose'.
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Randomised to receive information on food, diet and weight control practices based on the 'rational' behavioural model. Materials will be delivered on-line for 19-weeks, weekly.
Interventions/Control_2
Randomised to receive information on environment, working policies, food industry based on the 'stealth' behavioural model. Materials will be delivered on-line for 19-weeks, weekly.
Interventions/Control_3
No intervention
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Young adults registered to attend higher education in undergraduate level.
Key exclusion criteria
Postgraduate students or non-students.
Target sample size
870
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Charoula Konstantia Nikolaou |
Organization
University of Glasgow
Division name
Human Nutrition
Zip code
Address
New Lister Building, 10-16 Alexandra parade
TEL
+81-7923366331
c.nikolaou.1@research.gla.ac.uk
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Charoula Konstantia Nikolaou |
Organization
University of Glasgow
Division name
Human Nutrition
Zip code
Address
New Lister Building, 10-16 Alexandra parade
TEL
+81-7923366331
Homepage URL
http://www.gla.ac.uk/
c.nikolaou.1@research.gla.ac.uk
Sponsor or person
Institute
Debborah Stuart
Institute
Department
Personal name
Funding Source
Organization
Greek State Scholarship Foundation of Greece
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Greece
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
University of Glasgow
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 10 | 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
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 10 | Day |
Last modified on
| 2014 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016901
