UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046263 |
|---|---|
| Receipt number | R000052718 |
| Scientific Title | The efficacy of a specific health guidance program using a mobile health (mHealth) app on weight loss and blood pressure: a randomized controlled trial |
| Date of disclosure of the study information | 2021/12/02 |
| Last modified on | 2024/01/29 16:40:06 |
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Basic information
Public title
The efficacy of a specific health guidance program using a mobile health (mHealth) app on weight loss and blood pressure: a randomized controlled trial
Acronym
KENPO-app study
Scientific Title
The efficacy of a specific health guidance program using a mobile health (mHealth) app on weight loss and blood pressure: a randomized controlled trial
Scientific Title:Acronym
KENPO-app study
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy of a specific health check and guidance program using a mobile health (mHealth) app on weight loss and blood pressure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body mass index [Time Frame: 12 weeks]
Key secondary outcomes
Body weight Blood pressure Steps Subjective symptoms,exercise,diet,and lifestyle variables (in intervention group only)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Specific health guidance program using a mHealth app in combination with the weight scale,sphygmomanometer,and pedometer by a dietician/public health nurse
Interventions/Control_2
Specific health guidance program using a brochure in combination with
the weight scale, sphygmomanometer, and pedometer by a dietician/public health nurse
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Age:>=40,<65years old
2)BMI>=25kg/m2
3)SBP>=130mmHg and/or DBP>=85mmHg
4)Smartphone user and capable of installing apps
5)Capable of communication online
Key exclusion criteria
1) Receiving specific health guidance
2) anti-hypertensive medicine
3) Contraindication for healthy eating and active exercise by a doctor
4) Women who are pregnant or breast feeding
5) Inappropriate case by a research doctor
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | NAOKI |
| Middle name | |
| Last name | SAKANE |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Clinical Research Institute
Zip code
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto, 612-8555 JAPAN
TEL
075-641-9161
sakane.naoki.zn@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | AKIKO |
| Middle name | |
| Last name | SUGANUMA |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Clinical Research Institute
Zip code
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto, 612-8555 JAPAN
TEL
075-641-9161
Homepage URL
404-j-doit1@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
OMRON HEALTHCARE Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyoto Medical Center
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto, 612-8555 JAPAN
Tel
075-641-9161
yamaji.hirofumi.bg@mail.hosp.go.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
| 2021 | Year | 12 | Month | 02 | 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
| 2021 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 02 | Day |
Last modified on
| 2024 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052718
