UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037632 |
|---|---|
| Receipt number | R000042907 |
| Scientific Title | About the effects of the long-term nutrition counseling and dietary intake according to the behavioral modification stages in patients with heart disease(Before-after trials) |
| Date of disclosure of the study information | 2019/08/08 |
| Last modified on | 2023/07/19 15:11:05 |
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Basic information
Public title
About the effects of the long-term nutrition counseling and dietary intake according to the behavioral modification stages and consideration about effect factor to the blood pressure
Acronym
About the effects of the long-term nutrition counseling according to the behavioral modification stages
Scientific Title
About the effects of the long-term nutrition counseling and dietary intake according to the behavioral modification stages in patients with heart disease(Before-after trials)
Scientific Title:Acronym
About the effects of the long-term nutrition counseling according to the behavioral modification stages
Region
| Japan |
Condition
Condition
Heart disease
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The behavioral modification stages are used in several fields; however, no reports on long-term nutrition counseling(At the time of hospitalization, every 6 months, in implementation)according to such stages in patients with heart disease have been described. Therefore, this study aimed to consider its effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The salt intake as of the nutrition counseling end.
Key secondary outcomes
The behavioral modification stages, the nutriment intake(energy), weight, the blood pressure , body mass index (BMI),
total cholesterol (T-Cho), high-density lipoprotein cholesterol (HDL-Cho), low-density lipoprotein cholesterol (LDL-Cho), hemoglobin A1c (HbA1c),
uric acid (UA), estimated glomerular filtration rate (eGFR), Kihon Checklist as
of the nutrition counseling end.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
At the time of hospitalization, every 6 months, in implementation
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with heart disease who participated in the percutaneous coronary intervention treatment back and chronic phase after heart failure treatment to angina and acute myocardial infarction and continual nutrition counseling at the time of hospitalization and after leaving the outpatient department.
Key exclusion criteria
Patients with heart disease of death and stop of after leaving the outpatient department nutrition counseling.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Matsuzaki |
Organization
Fukuoka University Nishijin Hospital
Division name
Department of Nutrition
Zip code
814-8522
Address
15-7 Sohara, Sawara-ku, Fukuoka city, Fukuoka 814-8522, Japan.
TEL
092-831-1211
eiyoukeiko@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Matsuzaki |
Organization
Fukuoka University Nishijin Hospital
Division name
Department of Nutrition
Zip code
814-8522
Address
15-7 Sohara, Sawara-ku, Fukuoka city, Fukuoka 814-8522, Japan.
TEL
092-831-1211
Homepage URL
eiyoukeiko@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Nishijin Hospital Department of Nutrition
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University Nishijin Hospital
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
Fukuoka University Hospital
Address
45-1 Nanakuma, Jonan-ku, Fukuoka city, Fukuoka 814-0180, Japan.
Tel
092-801-1011
rinshou@adm.fukuoka-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
| 2019 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
http://www.hop.fukuoka-u.ac.jp/rinshou/doctor/shounin.html
Publication of results
Partially 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
| 2021 | Year | 01 | Month | 28 | Day |
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
| 2012 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 08 | Day |
Last modified on
| 2023 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042907
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
