UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022680 |
|---|---|
| Receipt number | R000026139 |
| Scientific Title | Effects of nutritional education on physical activity in patients with type 2 diabetes |
| Date of disclosure of the study information | 2016/06/09 |
| Last modified on | 2016/06/09 14:29:53 |
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Basic information
Public title
Effects of nutritional education on physical activity in patients with type 2 diabetes
Acronym
Effects of nutritional education on physical activity
Scientific Title
Effects of nutritional education on physical activity in patients with type 2 diabetes
Scientific Title:Acronym
Effects of nutritional education on physical activity
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of nutritional education on physical activity 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 physical activity from 0 to 16 weeks
Key secondary outcomes
Changes or percent changes of following parameters from 0 to 16 weeks
1)height, body weight, BMI, waist circumference
2)General Self efficacy Score (GSES),nutritional intake and dietary behavior,QOL
3)Body composition
fat mass, muscle mass and total body water volume measured by bioelectrical impedance analysis
4)Blood test
HbA1c, fasting plasma glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride, blood urea nitrogen, creatinine
5)Athletic ability
Grip power
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
1) using pedometers
2) nutritional education more than once every two month
Interventions/Control_2
using pedometers
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Aged >= 20
2) Patients with Type 2 Diabetes
3) Outpatient
4) Has never received nutritional education nor receive nutritional education at least three years by a registered dietitian
Key exclusion criteria
1) New patient
2) Has severe complications (cancer, hemodialysis, or blindness, etc)
3) Has diseases that affects physical activity (dismemberment, or rheumatic arthritis, etc)
4) Has psychiatric disorder
5) Has dementia
6) Pregnant or lactating
7) Has condition to avoid exercise
8) Has condition to be in-patient (severe ketosis, or sick day etc)
9) Considered inadequate by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoko Nakanishi |
Organization
Shiga University of Medical Science
Division name
Clinical nutrition
Zip code
Address
Seta Tsukinowa-cho, Otsu-city, Shiga, Japan 520-2192
TEL
077-548-2519
nakanish@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayaka Motoo |
Organization
Shiga University of Medical Science
Division name
Clinical nutrition
Zip code
Address
Seta Tsukinowa-cho, Otsu-city, Shiga, Japan 520-2192
TEL
077-548-2519
Homepage URL
motoo@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Doshisha women's College
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 06 | Month | 09 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 09 | Day |
Last modified on
| 2016 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026139
