UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051999 |
|---|---|
| Receipt number | R000059351 |
| Scientific Title | The effect of worksite diet and exercise intervention on glucose metabolism and body composition |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2026/09/21 13:01:51 |
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Basic information
Public title
The effect of worksite diet and exercise intervention on glucose metabolism and body composition
Acronym
The health effect of worksite diet and exercise intervention
Scientific Title
The effect of worksite diet and exercise intervention on glucose metabolism and body composition
Scientific Title:Acronym
The health effect of worksite diet and exercise intervention
Region
| Japan |
Condition
Condition
Glucose intolerance and diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the impact of worksite diet and exercise intervention on blood glucose fluctuations, body composition, energy metabolism, and psychological well-being.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postprandial hyperglycemia measured by flash glucose monitoring system
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Twelve week diet and exercise intervention, focusing on Mediterranean-style healthy Japanese food with free provision of olive oil, nuts and brown rice and everyday unsupervised home exercise with every 2week worksite advisory session.
Interventions/Control_2
Brief oral guidance on Mediterranean-style healthy Japanese food and verbal exercise instruction with a goal of 10,000 steps per day
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals without severe complications who are capable of engaging in exercise training
Individuals without allergies to olive oil, nuts, and brown rice
Individuals with diabetes or multiple of the following diabetes risk factors (Age 40 or above, BMI> 25, Smoking, Hypertension, Fasting plasma glucose> 100 mg/dl, HbA1c> 5.6%, and family history of diabetes).
Key exclusion criteria
Individuals who cannot perform training due to some reasons or are deemed to have difficulty in sustaining it.
Pregnant women or those wishing to become pregnant.
Individuals already engaging in sufficient exercise (more than 2 days a week, totaling over 2 hours of regular exercise).
Individuals with a body weight change of 5% or more during the six months before the intervention.
Individuals with tape allergies or those for whom wearing a 24-hour continuous glucose monitoring (CGM) device is impractical.
Individuals judged by the intervention personnel to have difficulty participating in or continuing with this study.
Target sample size
50
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,
Tokyo, Japan
Division name
Department of Medicine
Zip code
176-8530
Address
1-24-1, Asahigaoka, Nerima, Tokyo
TEL
03-5988-2200
azumakx@gmail.com
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, Tokyo
TEL
03-5988-2200
Homepage URL
azumakx@gmail.com
Sponsor or person
Institute
Nerima General Hospital and Institute of Healthcare Quality Improvement, Public Interest Incorporated Foundation Tokyo Healthcare Foundation, Tokyo, Japan
Institute
Department
Personal name
Funding Source
Organization
the Shokuraku Kenko Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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, Tokyo, Japan
Address
1-24-1, Asahigaoka, Nerima, Tokyo
Tel
03-5988-2200
ishijimu@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
| 2023 | Year | 10 | 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
31
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 | 07 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study was initially registered as a crossover trial; however, this was an error in study-design terminology. In the protocol finalized before study initiation, weeks 0 to 12 were designed as a randomized parallel-group comparison, whereas weeks 12 to 24 were planned as an exploratory extension period to assess persistence of effects after the intervention in the initial intervention group and to provide the intervention to the initial control group. This update corrects the study-design terminology to reflect the original protocol.
Management information
Registered date
| 2023 | Year | 08 | Month | 24 | Day |
Last modified on
| 2026 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059351
