UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006582 |
|---|---|
| Receipt number | R000007739 |
| Scientific Title | Lifestyle changes by delivery meals with dietitians: STYLIST Study |
| Date of disclosure of the study information | 2011/10/22 |
| Last modified on | 2013/04/20 12:43:12 |
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Basic information
Public title
Lifestyle changes by delivery meals with dietitians: STYLIST Study
Acronym
STYLIST Study
Scientific Title
Lifestyle changes by delivery meals with dietitians: STYLIST Study
Scientific Title:Acronym
STYLIST Study
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus, Impaired glucose tolerance or Essential hypertension
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of nutritional counseling by a registered dietitian for diabetes and hypertensive patients on lifestyle diseases under energy-controlled and low-sodium diets.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of body weight by nutritional counseling with or without energy-controlled meals
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Nutritional counseling (-) during observation period, nutritional counseling (-) under intake of delivery meal
Interventions/Control_2
Nutritional counseling (+) during observation period, nutritional counseling (-) under intake of delivery meal
Interventions/Control_3
Nutritional counseling (-) during observation period, nutritional counseling (+) under intake of delivery meal
Interventions/Control_4
Nutritional counseling (+) during observation period, nutritional counseling (+) under intake of delivery meal
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)Patients who meet one of the following criteria
1.Type 2 diabetes or Impaired glucose tolerance
2.Essential Hypertension
(2)Outpatient aged =>20 years old
(3)Eating meals regularly three times
(4)Informed consent
Key exclusion criteria
(1)Allergy for general food
(2)Stroke or myocardial infarction within three months
(3)Hemodialysis patient with end-stage renal disease
(4)Cancer patient or cancer treatment
(5)Inability to ingest or digest
(6)Secondary obesity
(7)HbA1c=>12%
(8)BMI<20,Height=>1.8m
(9)Calculated dietary calorie/day=<1200kcal/day
(10)Plan to change life habit or reduce body weight during the study
(11)Plan to change smoking habit during the study
(12)Pregnant, to plan pregnancy or lactation
(13)Ineligible conditions in investigator's judgment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keijiro Saku |
Organization
Fukuoka University
Division name
AIG Collaborative Research Institute of Cardiovascular Medicine, Fukuoka University
Zip code
Address
8-19-1,Nanakuma,Jyounan-ku,Fukuoka
TEL
092-801-1011(3366)
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keijiro Saku |
Organization
Fukuoka University
Division name
AIG Collaborative Research Institute of Cardiovascular Medicine, Fukuoka University
Zip code
Address
8-19-1,Nanakuma,Jyounan-ku,Fukuoka
TEL
092-801-1011(3366)
Homepage URL
Sponsor or person
Institute
AIG Collaborative Research Institute of Cardiovascular Medicine, Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Nissin Healthcare Food Service Co.Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Yuai Hospital
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
| 2011 | Year | 10 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 20 | Day |
Last modified on
| 2013 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007739
