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Effect of nutritional education through Internal Messenger on Blood glucose control, fat indicators and quality of life in patients with type 2 diabetes

Protocol summary

Study aim
Determining the Effect of Nutrition Education on the Control of Blood Glucose, Fat Indicators and Quality of Life in Patients with Type 2 Diabetes
Design
The two intervention and control groups are matched and randomly divided into two groups. The intervention group will have 45 days training on blood glucose control, fat and diet, and physical activity.
Settings and conduct
Place of study of Diabetes Research Center of Ahvaz Jundishapour University
Participants/Inclusion and exclusion criteria
Entry criteria: Internet access and Smartphone, reading and writing literacy, age (60-30 years). Exit criteria: failure to complete the questionnaire and control blood glucose, mental disorders, hospitalization due to other health problems, kidney disease and chronic complications of the disease
Intervention groups
The intervention and control groups completed a quality of life questionnaire. On a specified day, referring to the Laboratory of the Center for Research Without Cost, all 3cc blood samples were collected for fasting blood glucose, HBV1C, and blood lipids (triglyceride and cholesterol). As well as the weight of the patients, along with the test results, in the patients' questionnaires. After analyzing the received information, the questionnaire of patients in the case group was informed with the informed consent of the member of the internal messenger group. Training materials are provided to participants for 45 days each week from Saturday to Thursday, based on a regular program using pictures, videos and posters. In the afternoon, the patient's questions were answered for 2 hours. In the mean time, no intervention is provided for the control group. After 45 days after the last training session, all of the patients were tested, weight recorded, quality of life questionnaire completed.
Main outcome variables
Glucose control, weight, fat and quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121229011923N4
Registration date: 2019-01-21, 1397/11/01
Registration timing: registered_while_recruiting

Last update: 2019-01-21, 1397/11/01
Update count: 0
Registration date
2019-01-21, 1397/11/01
Registrant information
Name
Akram Hematipour
Name of organization / entity
Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8302
Email address
hematipour.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of nutritional education through Internal Messenger on Blood glucose control, fat indicators and quality of life in patients with type 2 diabetes
Public title
Effect of nutritional education through Internal Messenger on Blood glucose control, fat indicators and quality of life in patients with type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Internet access and Smartphone Literacy reading and writing Having a benchmark of age (60-30 years).
Exclusion criteria:
Failure to complete the questionnaire Mental disorders Lack of blood glucose control Hospitalization due to other health problems Kidney disease and chronic complications of diseases
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
They are matched in pairs and then divided randomly into two groups of intervention and control
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
Ethics committee of Ahvaz University of Medical Sciences
Street address
Jundishapour University of Ahvaz, Esfand Alley, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2018-12-29, 1397/10/08
Ethics committee reference number
IR.AJUMS.REC.1397.725

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Blood glucose
Timepoint
Before the study began and three months later
Method of measurement
blood test

2

Description
Cholesterol and triglycerides
Timepoint
Before the study began and three months later
Method of measurement
blood test

3

Description
Weight
Timepoint
Before the study began and three months later
Method of measurement
digital scale

4

Description
Quality of Life
Timepoint
Before the study began and three months later
Method of measurement
questionnaire SF36

Secondary outcomes

empty

Intervention groups

1

Description
"Intervention group": Patients in the intervention group completed the quality of life questionnaire(SF36) and tested fasting blood glucose, HBV1C and blood lipids (triglyceride and cholesterol) and their weights with informed consent of the members of the internal messenger group. Training sessions were completed within 45 days The week is from Saturday to Thursday, based on a regular schedule using pictures, videos, and posters to reach and maintain normal blood glucose levels and other dietary considerations. 45 days after the last intervention session, the quality of life questionnair and weight of patients were also checked again.
Category
Lifestyle

2

Description
Control group: During this period, the control group received routine care without any intervention.And the quality of life questionnaire, and blood glucose and lipid tests and patient weight are also checked
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Research Center of Ahvaz Jundishapour University
Full name of responsible person
Shahram Baraz
Street address
Jundishapour University of Ahvaz, Esfand Alley, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 7543
Email
shahrambaraz@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badavi
Street address
Jundishapour University of Ahvaz, Esfand Alley, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3336 1984
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Akram Hemmatipour
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Jundishapour University of Ahvaz, Esfand Alley, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6451984381
Phone
+98 61 3622 2217
Email
hematipour.a64@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahram Baraz
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Jundishapour University of Ahvaz, Esfand Alley, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3336 7543
Email
shahrambaraz@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Akram Hemmatipour
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Jundishapour University of Ahvaz, Esfand Alley, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6451984381
Phone
+98 61 3622 2217
Email
hematipour.a64@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
I do not know
When the data will become available and for how long
I do not know
To whom data/document is available
I do not know
Under which criteria data/document could be used
I do not know
From where data/document is obtainable
I do not know
What processes are involved for a request to access data/document
I do not know
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