UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028143 |
|---|---|
| Receipt number | R000032214 |
| Scientific Title | How should we promote self-weighing effectively in the workplace? |
| Date of disclosure of the study information | 2020/12/31 |
| Last modified on | 2024/02/17 18:07:46 |
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Basic information
Public title
How should we promote self-weighing effectively in the workplace?
Acronym
How should we promote self-weighing effectively in the workplace?
Scientific Title
How should we promote self-weighing effectively in the workplace?
Scientific Title:Acronym
How should we promote self-weighing effectively in the workplace?
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate a workplace intervention to promote regular self-weighting
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of employees who start self-weighing after invention (Measurement after six months)
Key secondary outcomes
Change of weight
Change of other heathy behavior
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
To encourage the particiants to change their life styles at one hour workshop
Interventions/Control_2
To let the participants promise behavior for self-weighing at one hour workshop
Interventions/Control_3
To inform the participants of obesity cost at one hour workshop
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Employees of local government who do not weigh themselves regularly
Key exclusion criteria
Employees who do not agree with participating with the workshop
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Yoshiike |
Organization
Aomori University of Health and Welfare
Division name
Garduate school of Health Science
Zip code
030-8505
Address
Aomori-ken Aomori-shi Hamadate Maze 58-1, Japan
TEL
017-765-2000
n_yoshiike@auhw.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Takebayashi |
Organization
Aomori University of Health and Welfare
Division name
Garduate school of Health Science
Zip code
030-8505
Address
Aomori-ken Aomori-shi Hamadate Maze 58-1, Japan
TEL
017-765-2000
Homepage URL
1691001@ms.auhw.ac.jp
Sponsor or person
Institute
Aomori University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Aomori Prefectual Government
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Aomori University of Health and Welfare
Address
Aomori-ken Aomori-shi Hamadate Maze 58-1, Japan
Tel
017-765-2000
rinri2008@auhw.ac.jp
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
青森県庁
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/kenkokyoiku/29/2/29_290202/_pdf/-char/ja
Publication of results
Partially published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/kenkokyoiku/29/2/29_290202/_pdf/-char/ja
Number of participants that the trial has enrolled
112
Results
Three intervention group [Quiz group (n=26, attractive-type nudges), implementation intentions group (n=25, social-type nudges), growth-mindset group (n=25, timely type nudges)] and a reference group (n=36, no nudges) was designed. After 6 months of interventions, all three interventions were effective for regular self-weighing (26.9%, 32.0%, and 60.0% in the quiz, implementation intentions, and growth-mindset groups; the growth-mindset group was significantly more effective).
Results date posted
| 2021 | Year | 10 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 03 | Month | 03 | Day |
Baseline Characteristics
The baseline characteristics of the participants did not show any significant differences; sex, age, BMI, and smoking habit.
Participant flow
Individuals who participated with their own free will and met the criterion of application of a self-weighing frequency less than once per week were enrolled in this study. If there were three or fewer participants in an organisation, then those participants formed one cluster. If there were four or more participants in any of the organisations, then they were randomly divided into clusters by a random number generator, from an anonymised applicant roster. These clusters were subsequently assigned to one of the three intervention groups (quiz group, implementation intention group, and growth-mindset group) randomly using the generator. Due to the nature of the workshop, it was difficult to assign applicants to a control group; therefore, employees from randomly selected institutions of the prefectural government were assigned to the reference group (eligibility criteria: self-weighing frequency as of September 2017 was less than once per week).
Adverse events
no
Outcome measures
The primary outcome was regular self-weighing after 6 months. The secondary outcomes were change in behavioural stage or mindset and weight maintenance.
In addition, the following items were extracted as they were assumed to be related to regular self-weighing: support from others, recording of regular weight measurements, and use of scales distributed at the workplace.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
| 2018 | Year | 06 | Month | 10 | Day |
Date trial data considered complete
| 2018 | Year | 06 | Month | 10 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 01 | Day |
Other
Other related information
Published
https://www.nature.com/articles/s41598-022-18916-z
Management information
Registered date
| 2017 | Year | 07 | Month | 08 | Day |
Last modified on
| 2024 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032214
| Research Plan | |
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