UMIN-CTR Clinical Trial

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
Email	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
Email	sumbalali7777@gmail.com

Sponsor
Institute	Bacha Khan University Charsadda, Khyber Pakhtunkhwa Province, Pakistan 25000
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056461