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The Effect of Nutrition Education on Control Blood Sugar, Lipid Profile, liver Enzymes and Quality of life in Middle-aged Women with type 2 Diabetes.

Protocol summary

Study aim
Determining and comparing the effect of nutrition education on blood glucose control, lipid profiles, insulin resistance, anthropometric indices, liver enzymes and quality of life in women with type 2 diabetes
Design
A clinical trial with community-based and practice-oriented intervention and control group, with parallel groups, is one-way blind and parallel. Qualified individuals are randomly assigned to the intervention and control group. The sample size was calculated for each group of 32, which increased the sample size to a sample size of 50 to increase accuracy.
Settings and conduct
This interventional study was performed on 100 female patients aged 30-60 years old with type 2 diabetes in two groups (50 subjects) in intervention group and (50 persons) in control group in Larestan. The information and experiments were studied in the study. Then, the intervention group received nutritional education for three months. After three months, all of the questionnaires and tests were reassessed from both groups. Control group after the end of the intervention period, all the training that was given to the intervention group was done for the control group.
Participants/Inclusion and exclusion criteria
Women with type 2 diabetes aged 30- 59 years old who had diabetes for one year or more and who were taking oral medications to control diabetes were included. People who were pregnant, breast-feeding, uncontrolled diabetes, or sedative, hypnotic drugs were not included in the study.
Intervention groups
Intervention group received educational intervention within three months. Control group: There was no intervention on these subjects.
Main outcome variables
Fasting blood glucose; Glycosylated hemoglobin (A1C); Lipid profile; Weight; Cholesterol; Hypertension; Liver enzymes; Fasting insulin; Nutritional awareness; Quality of life; Physical activity; Homa index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181118041687N1
Registration date: 2020-09-30, 1399/07/09
Registration timing: retrospective

Last update: 2020-09-30, 1399/07/09
Update count: 0
Registration date
2020-09-30, 1399/07/09
Registrant information
Name
elham dezhaloon
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5888 8105
Email address
dezhalooneli@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-15, 1397/03/25
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Nutrition Education on Control Blood Sugar, Lipid Profile, liver Enzymes and Quality of life in Middle-aged Women with type 2 Diabetes.
Public title
The Effect of Nutrition Education in Women with type 2 Diabetes.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Middle Aged WWomen are 30 to 59 Years Old. Have a one Year or more History of type 2 Diabetes. Willing to Participate in the Study. Use Oral Medications to Control your Blood Sugar. Do not take Insulin. Pregnant and lactating. Do not have any Special iIlnesses. Have no Thyroid Problems. There is no Definite Diet. Do not have Uncontrolled Diabetes. Have Mental Disabilities. Sleep, Tranquilizer, Antihistamines and Immune System Inhibitors.
Exclusion criteria:
One does not want to Continue to Study. The Person will Absent more than one Meeting. The Person leaves the Pre-test or Post-test. Tests are Misleading.
Age
From 30 years old to 59 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Qualified individuals were randomly assigned to intervention and control groups. (block balanced randomization). First, I wrote the letters A and B twice on six pieces of paper and put them in a container. Each time I referred, I took a piece of paper at random so that the fourth person could be identified in which group, then I put the paper in the container again I categorized those people into groups A (intervention) and B (control).
Blinding (investigator's opinion)
Single blinded
Blinding description
Only participants are unaware of the allocation of the study groups. The principal investigator is aware of the assignment of groups. The members of the intervention group were contacted confidentially and were invited to attend training classes. The control group received training after completing the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz, Razi Blvd, Facing the Power Club, Faculty of Nutrition and Food Sciences
City
Shiraz
Province
Fars
Postal code
7153675541
Approval date
2018-02-05, 1396/11/16
Ethics committee reference number
IR.SUMS.REC.1396.181

Health conditions studied

1

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

Primary outcomes

1

Description
Fasting blood glucose above 126mg / dl and high blood glucose levels of 180mg / dl
Timepoint
The beginning of the study (before intervention) and three months after the intervention began
Method of measurement
blood test

2

Description
Hemogolobin A1C above 6.5%
Timepoint
The bigining of the study (befor intervention) and teree monthe after the intervention began
Method of measurement
Koromatografi

3

Description
fasting Ansulin
Timepoint
The bigining of the study (befor intervention) and teree monthe after the intervention began
Method of measurement
Fasting serum insulin concentration using a commercial kit

Secondary outcomes

1

Description
Weight
Timepoint
The bigining of the study (befor intervention) and teree monthe after the intervention began
Method of measurement
Weight using seca scales with an accuracy of one hundred grams

2

Description
Waist
Timepoint
The bigining of the study (befor intervention) and teree monthe after the intervention began
Method of measurement
Scales

3

Description
Body mass index
Timepoint
The bigining of the study (befor intervention) and teree monthe after the intervention began
Method of measurement
Ratio of weight(in terms of kilogram) to the power of height(in terms of meters)

4

Description
Blood pressure
Timepoint
The bigining of the study (befor intervention) and teree monthe after the intervention began
Method of measurement
Using a standard mercury barometer

5

Description
High density of lipoprotein cholestrol
Timepoint
The bigining of the study (befor intervention) and teree monthe after the intervention began
Method of measurement
Blood test

6

Description
Low density of lipoprotein cholestrol
Timepoint
The bigining of the study (befor intervention) and teree monthe after the intervention began
Method of measurement
Blood test

7

Description
Triglyceride
Timepoint
The bigining of the study (befor intervention) and teree monthe after the intervention began
Method of measurement
Blood test

8

Description
Cholesterol
Timepoint
The bigining of the study (befor intervention) and teree monthe after the intervention began
Method of measurement
Blood test

9

Description
Alanine trans aminase
Timepoint
The bigining of the study (befor intervention) and teree monthe after the intervention began
Method of measurement
Blood test

10

Description
Aspartate transaminase
Timepoint
The bigining of the study (befor intervention) and teree monthe after the intervention began
Method of measurement
Blood test

11

Description
Homeostasis model assessment beta cell
Timepoint
The bigining of the study (befor intervention) and teree monthe after the intervention began
Method of measurement
Based on fasting glucose and insulin concentrations

12

Description
Homeostasis model assessment insulin resistance
Timepoint
The bigining of the study (befor intervention) and teree monthe after the intervention began
Method of measurement
Based on fasting glucose and insulin concentrations

13

Description
Quantitative insulin sensitivity check index
Timepoint
The bigining of the study (befor intervention) and teree monthe after the intervention began
Method of measurement
Based on fasting glucose and insulin concentrations

14

Description
The level of awareness of people
Timepoint
The bigining of the study (befor intervention) and teree monthe after the intervention began
Method of measurement
Questionnaire of Dr. Faqih et al

15

Description
Quality of life
Timepoint
The bigining of the study (befor intervention) and teree monthe after the intervention began
Method of measurement
Twelve quality of life questionnaire

16

Description
Get food
Timepoint
Three reminders at the beginning of the intervention and three reminders after the end of the educational intervention (Three months after the start of the training intervention)
Method of measurement
Using a 24-hour recall form

17

Description
Physical activity
Timepoint
The bigining of the study (befor intervention) and teree monthe after the intervention began
Method of measurement
Physical activity questionnaire metabolic equivalent Of task (MET)

Intervention groups

1

Description
Intervention group: Educational intervention with 4 sessions of nutrition training class in groups of 5-10 people with educational content of sessions including: stages of diabetes progression, symptoms of each stage and its side effects, providing nutritional recommendations to control diabetes and the importance of diet. Food groups and emphasis on increasing the number of meals, reducing the consumption of fats and simple carbohydrates, consuming whole grains and increasing the consumption of fruits and vegetables were held for the intervention group during three months. The average time per session was 70 minutes. The first session at the beginning of the study and in the form of an interactive lecture; The second session was held two weeks after the start of the study by small group techniques, the third session was held four weeks after the start of the study as an interactive lecture and the fourth session was held six weeks after the start of the study by lecture method. It was done by phone and all the recommendations were briefly reminded to the patient again.
Category
Lifestyle

2

Description
Control group:Educational intervention with 4 sessions of nutrition training class in groups of 5-10 people with educational content of sessions including: stages of diabetes progression, symptoms of each stage and its complications, providing nutritional recommendations to control diabetes and the importance of diet. They did not receive any intervention during these three months and were asked not to change their physical activity and diet during this period. But after the intervention, they received all the training provided to the intervention group.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Sahib Alzaman Clinic of Larestan
Full name of responsible person
Dr. Abbas Nasri
Street address
Old Town, North Modarres St., Coastal Street, Sahib Al-Zaman Clinic
City
Larestan
Province
Fars
Postal code
15515 - 74317
Phone
+98 71 5234 5300
Email
dezhalooneli@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Dr. Abbas Nasri
Street address
New Town - Azadi Blvd. Larestan Healthcare Network
City
Larestan
Province
Fars
Postal code
15515 - 74317
Phone
+98 71 5224 8083
Fax
+98 71 5224 2036
Email
dezhalooneli@yahoo.com
Grant name
Shiraz University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz 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

2

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
دکتر سیاوش باباجعفری
Street address
Khalili St
City
Shiraz
Province
Fars
Postal code
7193635899
Phone
+98 71 3612 2206
Email
jafaris@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Elham Dezhaloon
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Lar-The old city-square hozeh elmiye-Plaque3
City
Lar
Province
Fars
Postal code
74319-85679
Phone
+98 71 5888 8105
Fax
Email
dezhalooneli@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Elham Dezhaloon
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Lar-The old city-square hozeh elmiye-Plaque3
City
Lar
Province
Fars
Postal code
74319-85679
Phone
+98 71 5888 8105
Fax
Email
dezhalooneli@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Elham Dezhaloon
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Lar-The old city-square hozeh elmiye-Plaque3
City
Lar
Province
Fars
Postal code
74319-85679
Phone
+98 71 5888 8105
Fax
+98 74 3198 5679
Email
dezhalooneli@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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