UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046892 |
|---|---|
| Receipt number | R000053503 |
| Scientific Title | Randomized controlled trial for evaluation of behavior change by peer support type habituation app for people who are actively supported by specific health guidance(PEER-App Study) |
| Date of disclosure of the study information | 2022/02/14 |
| Last modified on | 2023/08/31 16:07:53 |
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Basic information
Public title
Randomized controlled trial for evaluation of behavior change by peer support type habituation app for people who are actively supported by specific health guidance(PEER-App Study)
Acronym
Randomized controlled trial for evaluation of behavior change by peer support type habituation app for people who are actively supported by specific health guidance(PEER-App Study)
Scientific Title
Randomized controlled trial for evaluation of behavior change by peer support type habituation app for people who are actively supported by specific health guidance(PEER-App Study)
Scientific Title:Acronym
Randomized controlled trial for evaluation of behavior change by peer support type habituation app for people who are actively supported by specific health guidance(PEER-App Study)
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effect of peer-supported habit-forming application on behavioral change toward lifestyle habits when it is used in addition to health guidance for those who fall under the category of active support for specific health guidance.
Basic objectives2
Others
Basic objectives -Others
At the beginning of the study, each individual will set a target number of steps to be taken each day, which will be achieved on a continuous basis. Participants will be randomly divided into two groups, one using the habit-forming app and the other not using the app, and changes in weight and lifestyle habits after three months and changes in health checkup data after one year will be compared.
The group using the habit-forming app will be challenged to achieve their individual goals by a team. For the non-use group, there is no team and they work alone to achieve their goals. For the group using the habit-forming app, the digital peer support of the habit-forming app will encourage behavioral change in health.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Amount and rate of weight change after 3 months
Key secondary outcomes
After 3 months:.
BMI change, change in abdominal circumference, change in body composition, change in steps from baseline, change in average steps per 2 weeks over time, change in self-efficacy (questionnaire for healthy people), change in lifestyle as assessed by standard questionnaire
After 1 year
Changes in physical examination values, changes in lifestyle habits as assessed by the standard questionnaire, changes in health guidance stratification judgment, changes in the percentage of people with metabolic syndrome, changes in the percentage of people who start medication for lifestyle-related diseases
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Using the Habituation App, you can know the number of steps you take every day, and challenge each person to achieve their goals in groups of five. Once a day about the results, post the number of steps + photos to your team and share information with each other.
Interventions/Control_2
Using the Steps app, you can know the number of steps you take every day, but don't have a team, work on your own goals. No posting or sharing of information will be done.
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Must have fallen under the category of "active support" in the specific health checkup in FY2021
2 Must be between the ages of 40 and 64
3 Use a smartphone on a daily basis
4 Those who have received sufficient explanation and given written consent of their own free will to participate in this study.
Key exclusion criteria
1 Those who have used the "Habit-forming Application (Minchare)" used in this study within the past 6 months
2 Heart disease, serious hepatic disorder, renal disorder, or malignant tumor (recurrence-free period of less than 5 years)
3. Patients with complications of infectious diseases
4 Those who have pacemakers or other internal devices installed.
5 Others who are deemed inappropriate by the research leader or co-worker
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Nishizaki |
Organization
Tokai University School of Medicine
Division name
Department of Clinical Health Science
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan
TEL
0463-93-1121
y-nishizaki@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Takashige |
| Middle name | |
| Last name | Oroguchi |
Organization
Tokai University School of Medicine
Division name
Lifecare Center Graduate School of Medicine
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan
TEL
0463-93-1121
Homepage URL
oroguchi@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
A10 Lab Inc.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Clinical Research, Tokai University Hospital
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan
Tel
0463-93-1121
tokai-rinsho@ml.tokai-u.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
| 2022 | Year | 02 | Month | 14 | 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
88
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
| 2021 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 20 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 20 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 12 | Day |
Last modified on
| 2023 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053503
