UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052514 |
|---|---|
| Receipt number | R000059917 |
| Scientific Title | A study to evaluate the efficacy of the Teaching Kitchen program in Japanese patients with diabetes |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2024/10/17 15:21:59 |
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Basic information
Public title
A study to evaluate the efficacy of the Teaching Kitchen program in Japanese patients with diabetes
Acronym
A study to evaluate the efficacy of the Teaching Kitchen program in Japanese patients with diabetes
Scientific Title
A study to evaluate the efficacy of the Teaching Kitchen program in Japanese patients with diabetes
Scientific Title:Acronym
A study to evaluate the efficacy of the Teaching Kitchen program in Japanese patients with diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of the new behavior modification program "Teaching Kitchen" which is integrating culinary training and lifestyle guidance towards healthy lifestyles in Japanese patients with type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in HbA1c
Key secondary outcomes
Changes in lifestyles and biometrics as well as participants' satisfaction of the program
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The program will include lectures on lifestyles and culinary trainings, and individual health coaching using wearable devices.
Interventions/Control_2
Start the same program four month after the start of the first group.
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Age 20 to 79
2)Those who have type 2 diabetes and HbA1c 6.5% to 8.9%
3)BMI >= 23 and/or waist circumference >= 85 cm for men and >= 90 cm for women
4)Those who agree to participate in the program
Key exclusion criteria
1)Type 1 diabetes and secondary diabetes
2)Those using rapid-acting insulin, regular insulin or premixed insulin containing them
3)Those who have been instructed by their physician to restrict protein (e.g., kidney or liver failure)
4)Those who have been instructed by their physician to limit exercise (e.g., heart failure requiring restriction of physical activity)
5)Those who are or may be pregnant or breastfeeding
6)Those with severe food allergies (anaphylactic shock)
7)Those with recent significant hypertension (systolic blood pressure >=180 mmHg or diastolic blood pressure >= 110 mmHg)
8)Those who have fasting triglycerides >=1,000 mg/dL on the most recent laboratory test
9)Those whom the principal investigator or attending physicians deems difficult to participate in the program or evaluate (e.g., physical or social factors, family objections, etc.).
Target sample size
200
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
06-6879-3736
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
06-6879-3736
Homepage URL
mbaden@endmet.med.osaka-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 01 | 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
116
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 08 | 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
| 2023 | Year | 10 | Month | 17 | Day |
Last modified on
| 2024 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059917
