UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058820 |
|---|---|
| Receipt number | R000064695 |
| Scientific Title | Promoting self-weighting using flyers with nudges |
| Date of disclosure of the study information | 2025/08/19 |
| Last modified on | 2025/08/17 18:55:50 |
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Basic information
Public title
Promoting self-weighting using flyers with nudges
Acronym
Promoting self-weighting using flyers with nudges
Scientific Title
Promoting self-weighting using flyers with nudges
Scientific Title:Acronym
Promoting self-weighting using flyers with nudges
Region
| Japan |
Condition
Condition
Obesity/ overweight
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measuring the impact of using a flyer to promote self-weighing based on nudging in health guidance on weight measurement behavior
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of self-weighing
Key secondary outcomes
Change of weight and behavioral stage
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The nudge group: A nudge-based poster to encourage participants self-weighing
Interventions/Control_2
The control group: A text-based poster to encourage participants self-weighing
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants who agree with the study
Key exclusion criteria
Participants who do not agree with the study, baseline self-weighing frequency of less than once a week, age less than 20 years or 70 years or older, occupational health staff
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Takebayashi |
Organization
Aomori University
Division name
Faculty of Sociology
Zip code
030-0943
Address
Aomori-ken Aomori-shi Koubata 2-3-1
TEL
0177652000
1691001@ms.auhw.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Takebayashi |
Organization
Aomori University
Division name
Faculty of Sociology
Zip code
030-0943
Address
Aomori-ken Aomori-shi Koubata2-3-1
TEL
017-738-2001
Homepage URL
1691001@ms.auhw.ac.jp
Sponsor or person
Institute
Aomori University
Institute
Department
Personal name
Masaki Takebayashi
Funding Source
Organization
Japan Family Planning Association, Inc
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aomori University Faculty of Sociology IRB
Address
Aomori-ken Aomori-shi Koubata2-3-1
Tel
017-738-2001
1691001@ms.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
青森県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 19 | 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
112
Results
In the intergroup comparison, the nudge group demonstrated a significantly greater positive effect than the control group, both in terms of progression to the stages of change and in the proportion of participants who avoided weight gain.
Results date posted
| 2025 | Year | 08 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study was conducted among members of the health insurance association of Japanese Company A, who received Specific Health Guidance during FY2024.
Participant flow
The intervention and data collection were carried out by occupational health nurses, who distributed flyers and baseline survey forms after the first SHG session and administered outcome survey forms at the final SHG session.
Adverse events
Nothing
Outcome measures
Individuals who increased self-weighing frequency; Individuals who proceeded stage of change: Body weight change; Individuals who did not gain body weight, after 6 months
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 17 | Day |
Last modified on
| 2025 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064695
