UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053679 |
|---|---|
| Receipt number | R000043473 |
| Scientific Title | Verification of self-weighing promotion program |
| Date of disclosure of the study information | 2024/02/22 |
| Last modified on | 2024/02/21 17:01:48 |
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Basic information
Public title
Verification of self-weighing promotion program
Acronym
Verification of self-weighing promotion program
Scientific Title
Verification of self-weighing promotion program
Scientific Title:Acronym
Verification of self-weighing promotion program
Region
| Japan |
Condition
Condition
obesity
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was aimed at examining the impact of a nudge-based obesity prevention program, hypothesizing that the integration of multiple nudges would increase self-weighing frequencies, thus facilitating long-term weight maintenance and loss.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
self-weighing frequency, participants who maintained their weights, and the weight change (at baseline, after six months of intervention, and after one year of intervention)
Key secondary outcomes
satisfaction with the workshop (just after the intervention), support from others (after six months) and recording of self-weighing (after six months)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The negative-priming group (participants underwent a paper test related to obesity disadvantages)
Nudge-based interventions were separately implemented at the beginning of the session, followed by a common lecture. The session concluded with a pair-work activity in which participants declared the time and place of self-weighing.
Interventions/Control_2
The positive-priming group (participants shared their success stories and received congratulations for their efforts)
Nudge-based interventions were separately implemented at the beginning of the session, followed by a common lecture. The session concluded with a pair-work activity in which participants declared the time and place of 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Older than 20 years
Key exclusion criteria
Participants who do not agree with participating with the workshop, pregnant women and those receiving weight-related guidance from their health care providers
Target sample size
220
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
Aomori University of Health and Welfare
Aomori Prefectual Government
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 22 | Day |
Related information
URL releasing protocol
https://nudge-takebayashi.jimdofree.com/%E7%A0%94%E7%A9%B6-%E5%AD%A6%E4%BC%9A/
Publication of results
Unpublished
Result
URL related to results and publications
https://nudge-takebayashi.jimdofree.com/%E7%A0%94%E7%A9%B6-%E5%AD%A6%E4%BC%9A/
Number of participants that the trial has enrolled
80
Results
After 1 year, 42 and 38 participants were included in the analysis in the negative-priming and positive-priming groups, respectively.
Results date posted
| 2024 | Year | 02 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The self-weighing participants' sex, age, body mass index (BMI), and smoking habits were recorded.
Participant flow
Participants were assigned numbers at the reception and allocated individually, approximately halved using a random number table. The first author conducted the allocation in accordance with the CONSORT statement.
Adverse events
nothing
Outcome measures
The primary outcome was the self-weighing frequency, participants who maintained their weights, and the weight change after 6 monthes and 1 year.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 21 | Day |
Last modified on
| 2024 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043473
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