UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046669 |
|---|---|
| Receipt number | R000052965 |
| Scientific Title | A feasibility study of a new behavior modification program integrating culinary training and lifestyle guidance towards healthy lifestyles |
| Date of disclosure of the study information | 2022/02/20 |
| Last modified on | 2024/01/29 15:04:10 |
* 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
A feasibility study of a new behavior modification program integrating culinary training and lifestyle guidance towards healthy lifestyles
Acronym
A feasibility study of a new lifestyle modification program
Scientific Title
A feasibility study of a new behavior modification program integrating culinary training and lifestyle guidance towards healthy lifestyles
Scientific Title:Acronym
A feasibility study of a new lifestyle modification program
Region
| Japan |
Condition
Condition
People with obesity and/or lifestyle related diseases.
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the feasibility of a new behavior modification program integrating culinary training and lifestyle guidance towards healthy lifestyles.
Basic objectives2
Others
Basic objectives -Others
To examine the feasibility.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In the short program, we will assess the participants' opinions and their lifestyle changes. In the long program, we will assess the program completion rate.
Key secondary outcomes
In the long program, we will assess participants' opinions, changes in lifestyles and physical findings, and the effective frequency of the programs.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
The short program will be conducted as a single-arm study and participants will take one class integrating culinary training and lifestyle guidance towards healthy lifestyles.
In the long program, participants will take four classes and individual health coaching by using wearable devices and will be divided into two groups regarding the class frequency. Those in one group will attend one class each week.
Interventions/Control_2
In the long program, participants will take four classes and individual health coaching by using wearable devices and will be divided into two groups regarding the class frequency. Those in the other group will attend one class every other week.
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
| 74 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Age 20 to 74
2) BMI >= 25 and/or waist circumference >= 85 cm for men and >= 90 cm for women
3)Those who agree to participate in the program
Key exclusion criteria
1) Those who require special diet therapy such as protein restriction
2)Those who require exercise restrictions
3) Those who are or possible to be pregnant or breastfeeding
4) Those who have other diseases that make it difficult to participate in the program
5) Those who have limitations that in the judgment of investigators may interfere with study participation or the ability to follow the protocol
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Megu |
| Middle name | |
| Last name | Baden |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Metabolic Medicine/ Department of Lifestyle Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Japan
TEL
06-6879-3732
mbaden@endmet.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Megu |
| Middle name | |
| Last name | Baden |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Metabolic Medicine/ Department of Lifestyle Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Japan
TEL
06-6879-3732
Homepage URL
https://www.med.osaka-u.ac.jp/pub/endmet/www/home/clinical.html
mbaden@endmet.med.osaka-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Japan Diabetes Society Young Research Grant
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
G-7 Foundation Research Grant, LOTTE Foundation Research Grant, KUBARA HONKE Co., Ltd., Cancer Scan. Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethic Review Board Osaka University Hospital
Address
2-2 Yamadaoka, Suita, Japan
Tel
06-6210-8290
rinri@hp-crc.med.osaka-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
大阪大学大学院医学系研究科（大阪府）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2022 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2022 | Year | 01 | Month | 19 | 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=R000052965
