UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044740 |
|---|---|
| Receipt number | R000051096 |
| Scientific Title | The effect of dietary lifestyle intervention on mental and physical health, using an original smartphone app |
| Date of disclosure of the study information | 2021/07/31 |
| Last modified on | 2021/11/09 17:22:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of dietary lifestyle intervention on mental and physical health, using an original smartphone app
Acronym
Changes in mental and physical health by a smartphone-based dietary intervention
Scientific Title
The effect of dietary lifestyle intervention on mental and physical health, using an original smartphone app
Scientific Title:Acronym
Changes in mental and physical health by a smartphone-based dietary intervention
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of dietary lifestyle intervention on mental and physical health, using an original smartphone app
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in body weight after 4-week intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Daily fasting time >14hr among participants with daily fasting time <12hr, along with the guidance of healthier dietary style recommended by Ministry of Health, Labor and Welfare, using an original smartphone app for 4 weeks
Interventions/Control_2
Only the guidance of healthier dietary style recommended by Ministry of Health, Labor and Welfare among participants with daily fasting time < 12hr
Interventions/Control_3
Only the guidance of healthier dietary style recommended by Ministry of Health, Labor and Welfare among participants not eating breakfast
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
Adults aged 20 years and older
Key exclusion criteria
Pregnancy
Comorbidities with drug treatment
Shift workers
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | KOICHIRO |
| Middle name | |
| Last name | AZUMA |
Organization
Nerima General Hospital and Institute of Healthcare Quality Improvement, Public Interest Incorporated Foundation Tokyo Healthcare Foundation
Division name
Department of Medicine
Zip code
176-8530
Address
1-24-1, Asahigaoka, Nerima
TEL
03-5988-2200
kazuma@nerima-hosp.or.jp
Public contact
Name of contact person
| 1st name | KOICHIRO |
| Middle name | |
| Last name | AZUMA |
Organization
Nerima General Hospital and Institute of Healthcare Quality Improvement, Public Interest Incorporate
Division name
Department of Medicine
Zip code
176-8530
Address
1-24-1, Asahigaoka, Nerima
TEL
0359882200
Homepage URL
kazuma@nerima-hosp.or.jp
Sponsor or person
Institute
Nerima General Hospital and Institute of Healthcare Quality Improvement, Public Interest Incorporated Foundation Tokyo Healthcare Foundation
Institute
Department
Personal name
Funding Source
Organization
Oishi Kenko Incorporated, Tokyo, Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nerima General Hospital and Institute of Healthcare Quality Improvement, Public Interest Incorporated Foundation Tokyo Healthcare Foundation
Address
1-24-1, Asahigaoka, Nerima
Tel
0359882200
ykobayashi@nerima-hosp.or.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 | 07 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 09 | 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
| 2021 | Year | 07 | Month | 02 | Day |
Last modified on
| 2021 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051096
