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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043779
Receipt No. R000049974
Scientific Title Effects of different interventions for breaking-up sedentary behavior on postprandial blood glucose and lipid profiles in young adults
Date of disclosure of the study information 2021/03/29
Last modified on 2021/03/29

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Basic information
Public title Effects of different interventions for breaking-up sedentary behavior on postprandial blood glucose and lipid profiles in young adults
Acronym Effects of different interventions for breaking-up sedentary behavior on postprandial blood glucose and lipid profiles in young adults
Scientific Title Effects of different interventions for breaking-up sedentary behavior on postprandial blood glucose and lipid profiles in young adults
Scientific Title:Acronym Effects of different interventions for breaking-up sedentary behavior on postprandial blood glucose and lipid profiles in young adults
Region
Japan

Condition
Condition Noncommunicable diseases
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aimed to assess the effects of breaking-up sedentary behavior using different intervention strategies on postprandial blood glucose and lipid profiles.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes blood glucose
Key secondary outcomes triglyceride
insulin
volume of physical activity
energy intake

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 4
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Sitting with 3 min bouts of walking every 30 min
Interventions/Control_2 Sitting with 3 min bouts of jogging with walking speed every 30 min
Interventions/Control_3 Uninterrupted sitting using a stability ball as a chair
Interventions/Control_4 Uninterrupted sitting using a normal chair
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
40 years-old >=
Gender Male and Female
Key inclusion criteria People who fully understand the purpose of research, risks associated with the research intervention, obligations and consequences of research participation, and his/her right of withdrawing consent any time during the study
Key exclusion criteria People who have concomitant diseases/injuries affecting enforcement of safety physical activity, including 1) with a history of cardiovascular disease including recent myocardial infarction, 2) severe lever or kidney diseases, 3) hypertension or diabetes mellitus, 4) a person who is scheduled to have an operation (surgery), 5) a patient who is recovering/treatment from/in other serious diseases, 6) During pregnancy, 7) eating disorder
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Hideaki
Middle name
Last name Kumahara
Organization Nakamura Gakuen University
Division name Faculty of Nutritional Sciences
Zip code 814-0198
Address 5-7-1 Befu, Jonan-ku, Fukuoka 814-0198, Japan
TEL 092-851-2531
Email kumahara-h@umin.ac.jp

Public contact
Name of contact person
1st name Hideaki
Middle name
Last name Kumahara
Organization Nakamura Gakuen University
Division name Faculty of Nutritional Sciences
Zip code 814-0198
Address 5-7-1 Befu, Jonan-ku, Fukuoka 814-0198, Japan
TEL 092-851-2531
Homepage URL
Email kumahara-h@umin.ac.jp

Sponsor
Institute Nakamura Gakuen University
Institute
Department

Funding Source
Organization Nakamura Gakuen University
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 Nakamura Gakuen University
Address 5-7-1 Befu, Jonan-ku, Fukuoka 814-0198, Japan
Tel 092-851-2531
Email kks@nakamura-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
2021 Year 03 Month 29 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 Enrolling by invitation
Date of protocol fixation
2021 Year 03 Month 24 Day
Date of IRB
2021 Year 03 Month 24 Day
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2024 Year 04 Month 30 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 03 Month 29 Day
Last modified on
2021 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049974

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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