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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006582
Receipt No. 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

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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)
Email

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
Email

Sponsor
Institute AIG Collaborative Research Institute of Cardiovascular Medicine, Fukuoka University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007739

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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