UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049575 |
|---|---|
| Receipt number | R000056461 |
| Scientific Title | A Novel Approach for Diabetes Intervention Using a Health Story-Telling Technique |
| Date of disclosure of the study information | 2022/11/21 |
| Last modified on | 2022/11/21 17:07:16 |
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Basic information
Public title
A Novel Approach for Diabetes Intervention Using a Health Story-Telling Technique
Acronym
A Novel Approach for Diabetes Intervention Using a Health Story-Telling Technique
Scientific Title
A Novel Approach for Diabetes Intervention Using a Health Story-Telling Technique
Scientific Title:Acronym
A Novel Approach for Diabetes Intervention Using a Health Story-Telling Technique
Region
| Asia(except Japan) |
Condition
Condition
Storytelling as health intervention in diabetic
Classification by specialty
| Endocrinology and Metabolism | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The overall aim of the present study was to investigate the effect of a health storytelling as a counseling intervention on diabetes management.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
improvement in blood glucose levels
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
diabetic patients
Interventions/Control_2
diabetic patients
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
diabetic, adults, both genders, any BMI
Key exclusion criteria
non-diabetic, non-hypertensive, non-Pakistanis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sumbal |
| Middle name | |
| Last name | Ali |
Organization
Bacha Khan University Charsadda, KPK, Pakistan
Division name
Human Nutrition and Dietetics
Zip code
25000
Address
Bacha Khan University Charsadda, Khyber Pakhtunkhwa Province, Pakistan 25000
TEL
00923455104041
sumbalali7777@gmail.com
Public contact
Name of contact person
| 1st name | Sumbal |
| Middle name | |
| Last name | Ali |
Organization
Bacha Khan University Charsadda, Khyber Pakhtunkhwa Province, Pakistan 25000
Division name
Human Nutrition and Dietetics
Zip code
25000
Address
Bacha Khan University Charsadda, Khyber Pakhtunkhwa Province, Pakistan 25000
TEL
00923455104041
Homepage URL
sumbalali7777@gmail.com
Sponsor or person
Institute
Bacha Khan University Charsadda, Khyber Pakhtunkhwa Province, Pakistan 25000
Institute
Department
Personal name
Funding Source
Organization
Bacha Khan University Charsadda, Khyber Pakhtunkhwa Province, Pakistan 25000
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NEAT
Address
NEAT, Charsadda, Khyber Pakhtoonkhwa (KPK), Pakistan
Tel
00923455104041
dr.qazinoor@gmail.com
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
| 2022 | Year | 11 | Month | 21 | Day |
Related information
URL releasing protocol
http://bkuc.edu.pk
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
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
| 2022 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 21 | Day |
Last modified on
| 2022 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056461
| Research Plan | |
|---|---|
| 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 |
