Protocol summary

Summary
Abstract: Diabetes mellitus is the most common glandular disorder worldwide and is responsible for 4 million deaths per year. The prevalence of type two diabetes in our population over 30 years is estimated between 6/5-10/6 percent. Self -care and patient education are the bases to identify and control of diabetes. Nutritional intervention is the inseparable component of self-care education and management of diabetes. Theories of behavioral and social sciences have an important role to establish effective health education programs .There is no motive like the inner belief and incentive, to motivate the behavior. The method of care of soul is one of the common ways to self-making, behavior change and reformation in Islamic ethics and mysticism. The purpose of this study is to determine the effect of the educational package based on Islamic teachings on nutritional self-care behavior and metabolic control of middle-aged patients with type two diabetes referred to the Diabetes Center, Mazandaran University of Medical Sciences. This is a quasi-experimental study. The study population is the patients with type two diabetes attending the Diabetes Center in Sari, Mazandaran University of Medical Sciences. The study is done in two steps. In the first stage during a cross sectional study, at least 30 patients of the target population will respond to the questionnaires. The educational program will be designed and implemented based on the study results. In the interventional phase eligible patients will be divided to experimental and control groups by random assignment (at least 30 patients in each group). Questionnaires of Knowledge, Attitude and Practice (KAP) on nutritional self-care behavior and Islamic teachings will be offered to both groups as pre-tests. HbA1C, lipid and glucose will be tested. Weight and blood pressure measurements will be performed. Afterward the teaching sessions to train educational package according to Islamic care method will be offered to the experimental group. 3 months later, KAP study of nutritional self-care behavior and Islamic teachings will be performed in both groups as post-tests. Metabolic tests and physical indices measurements will be repeated again. The results will be compared using statistical tests.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016010325826N1
Registration date: 2016-02-03, 1394/11/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-02-03, 1394/11/14
Registrant information
Name
Manizheh Zakizad Abkenar
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3569
Email address
m.zakizadabkenar@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To studty the effect of educational package based on Islamic teachings on nutritional self-care behavior and metabolic control of middle-aged patients with type two diabetes referred to the Diabetes Center, Mazandaran University of Medical Sciences
Public title
Islamic teachings and nutrition of diabetic patients
Purpose
Other
Inclusion/Exclusion criteria
inclusion: afflicted with type 2 diabetes for at least one year before study, Age between 30 to 65 years old (middle age), HbA1C between 6.5- 9, Men and women, Adequate literacy, Belief in to Islam, No change in drug regimen by the physician at least during the first 3 months of research, to be Interested in participating in the research. exclusion: to be Pregnant (or plan to become pregnant during the study), breastfeeding,Chronic kidney disease, heart disease, cancer, No change in drug regimen by the physician at least during the first 3 months of research,Lack of interest to participate in research, Unable to Make Calls
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 98
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tarbiat Modares University
Street address
Tarbiat Modares University, Jalal Ale Ahmad Highway, P.O.Box: 14115-111, Tehran, Iran
City
Tehran
Postal code
14115-111
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
52/1456د

2

Ethics committee
Name of ethics committee
Tarbiat Modares University
Street address
Tarbiat Modares University, Jalal Ale Ahmad Highway, P.O.Box: 14115-111, Tehran, Iran
City
Tehran
Postal code
14115-111
Approval date
2014-05-17, 1393/02/27
Ethics committee reference number
د52/1456

3

Ethics committee
Name of ethics committee
Tarbiat Modares University
Street address
Tarbiat Modares University, Jalal Ale Ahmad Highway, P.O.Box: 14115-111, Tehran, Iran
City
Tehran
Postal code
14115-111
Approval date
2014-05-17, 1393/02/27
Ethics committee reference number
52/1456د

Health conditions studied

1

Description of health condition studied
diabetes
ICD-10 code
E10,E11,E1
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
WEIGHT, blood pressure, glucose, lipid, HbA1C
Timepoint
before and 2 months after intervention
Method of measurement
Weight (kg), blood pressure (mmHg), fasting plasma sugar (mg/dL), blood sugar two hours post prandial(mg/dL), Cholesterol (mg/dL), triglycerides (mg/dL), LDL (mg/dL), HDL (mg/dL), glycosylated hemoglobin (HbA1C): percent

2

Description
nutritional self-care behavior and metabolic and Anthropometric indexes
Timepoint
before and 2 months after intervention
Method of measurement
Weight (kg), blood pressure (mmHg), fasting plasma sugar (mg/dL), blood sugar two hours post prandial(mg/dL), Cholesterol (mg/dL), triglycerides (mg/dL), LDL (mg/dL), HDL (mg/dL), glycosylated hemoglobin (HbA1C): percent

Secondary outcomes

1

Description
Knowledge, Attitude and practice of Nutritional self care
Timepoint
Before and 2 months after intervention
Method of measurement
multi choice questions of Knowledge and practice, Likert questions of Attitude

Intervention groups

1

Description
10 hours of nutritional education, Islamic teachings and Islamic care method for intervention group
Category
Other

2

Description
10 hours of nutritional education for the control group
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Center, Mazandaran University of Medical Sciences
Full name of responsible person
Fahimeh Akbardokht
Street address
Diabetes Center, Imam hospital
City
Sari

2

Recruitment center
Name of recruitment center
Diabetes Center, Mazandaran University of Medical Sciences
Full name of responsible person
Fahimeh Akbardokht
Street address
Diabetes Center, Imam hospital
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mansoureh Movahedin
Street address
Anatomical Sciences Dept., Medical Sciences Faculty, Tarbiat Modares University, Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mansoureh Movahedin
Street address
Anatomical Sciences Dept., Medical Sciences Faculty, Tarbiat Modares University, Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

3

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mansoureh Movahedin
Street address
Anatomical Sciences Dept., Medical Sciences Faculty, Tarbiat Modares University, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Manizheh Zakizad Abkenar
Position
PhD student in health education and health promotion
Other areas of specialty/work
Street address
Tarbiat Modares University -Tehran - Iran P.O.Box:14115-111
City
Tehran
Postal code
14115-111
Phone
+98 21 8288 4555
Fax
Email
M.zakizad abkenar@MODARES.AC.IR
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modarres University
Full name of responsible person
Fazlollah Ghofranipour
Position
professor
Other areas of specialty/work
Street address
Dept. of Health Education, School of Medical Sciences, Tarbiat Modarres University, P.O. Box: 14115-111, Tehran, Iran.
City
Tehran
Postal code
14115-111
Phone
+98 21 8288 3869
Fax
+98 21 8288 4555
Email
ghofranf@modares.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Manizheh Zakizad Abkenar
Position
PhD student in health education and health promotion
Other areas of specialty/work
Street address
health education and health promotion Dept., Medical Sciences Faculty, Tarbiat Modares University, Tehran, Iran.
City
Tehran
Postal code
14115-111
Phone
+98 11 3334 4586
Fax
Email
zakizadeha@ yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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