UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050437 |
|---|---|
| Receipt number | R000057445 |
| Scientific Title | Effectiveness of the Brief Online Intermittent Fasting Program for Weight Loss: A Randomized Controlled Pilot Study |
| Date of disclosure of the study information | 2023/02/27 |
| Last modified on | 2024/02/02 10:45:57 |
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Basic information
Public title
Online weight-loss trial of intermittent fasting
Acronym
Online IF Study
Scientific Title
Effectiveness of the Brief Online Intermittent Fasting Program for Weight Loss: A Randomized Controlled Pilot Study
Scientific Title:Acronym
Online IF study
Region
| Japan |
Condition
Condition
Obesity and Overweight
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness, feasibility and safety of the Brief Online Intermittent Fasting Program for weight-loss, as a pilot study of a randomized controlled trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in body weight after 12 week-intervention
Key secondary outcomes
Effectiveness:
- Change in BMI
- Change in body fat percentage
- Change in fat mass
- Change in fat-free mass
- Change in muscle mass
- Change in blood pressure (SBP and DBP)
- Change in HbA1c
- Change in triglyceride
- Change in total cholesterol
- Change in HDL cholesterol
- Change in LDL cholesterol
- Change in QOL score (physical and mental 2-component summary score) measured by SF-12v2 Japanese ver
- Change in Total Physical Activity measured by IPA-Q short ver
- Read status of weekly messages sent via mobile app
Feasibility:
- Follow-up proportion of each group
- Adherence to each intervention
Safety Analysis:
- Self-reported adverse events
- Within Group Difference in QOL score
Exploratory Analysis:
- Change in self-reported body weight recorded via mobile app (exploratory)
- Change in self-reported number of steps recorded via mobile app (exploratory)
- Comments and feedbacks to the IF program measured by questionaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Instruction to the brief online intermittent fasting program (about 10 minutes) at beginning.
Weekly 1 day fasting - participants intake around 400kcal by provided fasting food.
Weekly message via app: encouragement and reminder of fasting
Interventions/Control_2
Minimal care
- Weekly message via app: general advices on eating, exercise, sleep
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Generally healthy adults who
aged 20 to 65
whose BMI 23 or more.
can take regular 1 day off.
can communicate in Japanese.
have access to the Internet and can use mobile app during the study.
can visit Kyoto university at baseline and 12th week for the outcome measurement.
can have blood drawn and fast before at the measurements.
understand the study content and are willing to join the program.
Key exclusion criteria
BMI 35 or more.
have history of heart disease, kidney disease, and other major medical conditions.
medication of anti-diabetics.
smoker or heavy drinker - average 4 or more drinks per day, or 14 or more drinks per week.
night-shift worker.
possibility of moving, job change, travel abroad and other substantial change of living condition.
lactating, pregnant, or plan to be pregnant during the study.
men with fat percentage of 10% or less, or women with fat percentage of 20% or less.
professional or amateur athletes.
commitment to athletic or physical training of 12 hours or more per week.
other reasons recognized as inappropriate by the researcher.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Iwami |
Organization
Graduate School of Medicine of Kyoto University
Division name
Department of Preventive Services, School of Public Health.
Zip code
606-8501
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
TEL
075-753-2426
iwami.taku.8w@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomonari |
| Middle name | |
| Last name | Shimamoto |
Organization
Graduate School of Medicine of Kyoto University
Division name
Department of Preventive Services, School of Public Health.
Zip code
606-8501
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
TEL
075-753-2426
Homepage URL
https://yobou.med.kyoto-u.ac.jp/onlineifstudy_pilot/
onlineifstudy@yobou.med.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ritsuan STC Inc
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Health and Nutrition, The University of Shimane.
Faculty of Home Economics, Department of Food Science, Otsuma Women's University.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo--ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
京都大学大学院医学研究科（京都府）
医療法人大和会 日下病院（三重県）
（株）コールドストレージ・ジャパン（東京都）
（株）バディトレ（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 27 | 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
| 2023 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 12 | Day |
Date of closure to data entry
| 2024 | Year | 01 | Month | 12 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2024 | Year | 01 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 27 | Day |
Last modified on
| 2024 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057445
