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Investigating the effect of consuming a diet based on high adherence to the Global Diet Quality Score (GDQS) with a standard diet on the control of sugar factors, mental health and anthropometric indicators in patients with type 2 diabetes: a randomized clinical trial

Protocol summary

Study aim
Comparing the effect of GDQS diet with standard diet on blood sugar control, mental health and anthropometric indicators in people with type 2 diabetes
Design
A randomized, parallel, controlled clinical trial. The number of 134 participants qualified to participate in the study will be divided into one of 2 intervention and control groups (n=67) using a simple randomization method
Settings and conduct
This study will be done in Yazd Diabetes Clinic Center. A total of 134 eligible people will be randomly assigned to 2 groups for 12 weeks to receive GDQS or standard dietary recommendations. At the beginning of the study and after 12 weeks from the start of the study, HBA1C, fasting glucose, weight, height, body mass index, waist circumference, depression, anxiety, quality of life, quality of sleep and people's adherence to diets will be evaluated
Participants/Inclusion and exclusion criteria
People with type 2 diabetes with age ≥ 18 years and body mass index ≤ 40 kg / m2 who complete the consent form to enter the study. Conditions of non-entry: including uncontrolled diabetes (HbA1C more than 9 mg / dL). , pregnancy, breastfeeding, acute mental disorders, consumption of alcohol, drug abuse, use of thiazide diuretics
Intervention groups
Intervention group: Subjects will receive the GDQS diet. Participants will learn the GDQS diet in 3 face-to-face sessions. They will also receive GDQS dietary advice during the course. Control group: subjects will receive standard diet. Participants will learn the standard diet in 3 face-to-face sessions. They will also receive standard dietary advice throughout the course. The duration of the intervention and study will be 12 weeks.
Main outcome variables
HBA1C, fasting glucose, weight, height, body mass index, waist circumference, depression, anxiety, quality of life, quality of sleep and people's adherence to diets

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210427051098N4
Registration date: 2023-12-01, 1402/09/10
Registration timing: prospective

Last update: 2023-12-01, 1402/09/10
Update count: 0
Registration date
2023-12-01, 1402/09/10
Registrant information
Name
Sayyed Saeid Khayyatzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 9100
Email address
khayyatzadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of consuming a diet based on high adherence to the Global Diet Quality Score (GDQS) with a standard diet on the control of sugar factors, mental health and anthropometric indicators in patients with type 2 diabetes: a randomized clinical trial
Public title
Investigating the effect of diet consumption based on high adherence to the global diet quality score on the control of sugar factors, mental health and anthropometric indicators in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants with type 2 diabetes Fasting blood glucose level ≥ 126 mg/dL The two-hour plasma glucose level ≥200 mg/dL Consumption of oral hypoglycemic medications Body mass index (BMI) ≤ 40 kg/m2 Completion of informed consent
Exclusion criteria:
Uncontrolled diabetes (HbA1C more than 9 mg/dl) Suffering from diabetic nephropathy History of ischemic heart disease pregnancy Lactation History of hospitalization for the treatment of heart disease during the last 6 months History of cancer treatment in the last 5 years Suffering from proteinuria History of steroid treatment during the last 3 months Suffering from thyroid disease History of lung disease and compliance with special diet Suffering from hepatitis Suffering from gastrointestinal disease Suffering from pancreatitis Suffering from inflammatory bowel disease Bowel resection Infected with AIDS Suffering from acute mental disorders Suffering from Cushing's syndrome Alcohol consumption Drug abuse Taking thiazide diuretics Taking antidepressants
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 134
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization based on gender (male and female) and BMI (above and below 25) as randomization stratified randomization with a block size equal to 8 and 2 times will be repeated. The group assigned to the people will be placed in sealed envelopes in advance and then when the participant visits and after the approval of the eligible The condition of entering the study is that the envelope will be opened and will be placed in the designated group.
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 Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Sciences and Health Services Campus- Shohadaye Gomnam Blvd- Alem Square- Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2023-11-25, 1402/09/04
Ethics committee reference number
IR.SSU.SPH.REC.1402.104

Health conditions studied

1

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

Primary outcomes

1

Description
HBA1C
Timepoint
Before the intervention, 12 weeks after the intervention
Method of measurement
Blood test

2

Description
Fasting Plasma Glucose (FPG)
Timepoint
Before the intervention, 12 weeks after the intervention
Method of measurement
Blood sample

3

Description
Insulin
Timepoint
Before the intervention, 12 weeks after the intervention
Method of measurement
Blood sample

4

Description
Insulin resistance index
Timepoint
Before the intervention, 12 weeks after the intervention
Method of measurement
Formula

5

Description
Triacyl glyceride (TG)
Timepoint
Before the intervention, 12 weeks after the intervention
Method of measurement
Blood sample

6

Description
Total cholesterol
Timepoint
Before the intervention, 12 weeks after the intervention
Method of measurement
Blood sample

7

Description
High Density Lipoprotein (HDL)
Timepoint
Before the intervention, 12 weeks after the intervention
Method of measurement
Blood sample

8

Description
Low Density Lipoprotein (LDL)
Timepoint
Before the intervention, 12 weeks after the intervention
Method of measurement
Blood sample

9

Description
Anxiety
Timepoint
Before the intervention, 12 weeks after the intervention
Method of measurement
Beck validated questionnaire

10

Description
Depression
Timepoint
Before the intervention, 12 weeks after the intervention
Method of measurement
Beck validated questionnaire

11

Description
Sleep quality
Timepoint
Before the intervention, 12 weeks after the intervention
Method of measurement
Pittsburgh validated questionnaire

12

Description
Quality of Life
Timepoint
Before the intervention, 12 weeks after the intervention
Method of measurement
SF-36 validated questionnaire

Secondary outcomes

1

Description
Height
Timepoint
Before the intervention, 12 weeks after the intervention
Method of measurement
Tape measure

2

Description
Weight
Timepoint
Before the intervention, 12 weeks after the intervention
Method of measurement
Weighting scale

3

Description
Body Mass Index (BMI)
Timepoint
Before the intervention, 12 weeks after the intervention
Method of measurement
Body composition analyzer

4

Description
Waist circumference
Timepoint
Before the intervention, 12 weeks after the intervention
Method of measurement
Tape measure

5

Description
Hips circumference
Timepoint
Before the intervention, 12 weeks after the intervention
Method of measurement
Tape measure

6

Description
Fat mass
Timepoint
Before the intervention, 12 weeks after the intervention
Method of measurement
Body composition analyzer

7

Description
Fat free mass
Timepoint
Before the intervention, 12 weeks after the intervention
Method of measurement
Body composition analyzer

8

Description
Blood pressure
Timepoint
Before the intervention, 12 weeks after the intervention
Method of measurement
Measurement of systolic and diastolic blood pressure (mmHg)

Intervention groups

1

Description
Intervention group:In the diet group based on the GDQS index, people with type 2 diabetes were given GDQS diet training for 3 sessions (the first week before the start of the intervention, the fourth week, and the eighth week of the intervention) and each session lasted 30 minutes. they take. People with type 2 diabetes will be randomly selected and placed in the standard or GDQS group. If there were two participants from the same family with type 2 diabetes, both would be randomly assigned to the standard or GDQS group. The amount of prescribed energy intake for people is calculated according to the Harris-Benedict equation. If the body mass index of people is less than 25, the current weight of people is used to calculate energy; But if the body mass index is more than 25, the adjusted weight of people according to the body mass index of 25 is used to calculate energy. The weight loss phase for overweight and obese people ends immediately after reaching a body mass index of less than 25. People will be taught how to cook different foods according to dietary recommendations. Diet recommendations based on GDQS will be adjusted according to the amount of energy needed by the person, which for a diet containing 1600 calories, 6-8 servings of fruits and vegetables per day, 7-8 servings of nuts and seeds per week, at least 6.5 servings of grains (half 2-3 daily servings of non-fat and low-fat dairy products, maximum 150 grams of meat (with an emphasis on fish and chicken), will be recommended. In training sessions, dietary recommendations based on GDQS will be fully explained to people. These recommendations will be based on the economic status of people's access to food and the status of some other diseases such as digestive diseases. Also, people will be taught how to cook different foods according to dietary recommendations. People's adherence to the diet will be checked once a week through a phone call. People are taught to consume a piece of fruit, a glass of drink with barley bread or crispy bread when mild hypoglycemic symptoms occur (hunger, sweating, increased heart rate, and confusion)
Category
N/A

2

Description
Control group:Prescribing diet in the standard group: the amount of prescribed energy intake for people is calculated according to the Harris-Benedict equation. If the body mass index of people is less than 25, the current weight of people is used to calculate energy; But if the body mass index is more than 25, the adjusted weight of people according to the body mass index of 25 is used to calculate energy. The weight loss phase for overweight and obese people ends immediately after reaching a body mass index of less than 25. People will be taught how to cook different foods according to dietary recommendations. The recommendations of the control diet will be adjusted according to the amount of energy needed by the individual and will contain 55% carbohydrates, 15% protein, 30% fat, and less than 5% energy from simple sugars. These recommendations will be based on the economic status of people's access to food and the status of some other diseases such as digestive diseases. Also, people will be taught how to cook different foods according to dietary recommendations. People's adherence to the diet will be checked once a week through a phone call. The number of training sessions in the standard diet group will be 3 sessions (the first week before the intervention, the fourth week, and the eighth week of the intervention) and healthy food recommendations will be taught to people. People are taught to consume a piece of fruit, a glass of drink with barley bread, or crispy bread when mild hypoglycemic symptoms occur (hunger, sweating, increased heart rate, and confusion). People with type 2 diabetes are randomly placed in this group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Research Center and Clinics
Full name of responsible person
Sayyed Saeid Khayyatzadeh
Street address
Buyuk Alley,Talar Honar St, North Shahid Sadoughi Blvd, Yazd City
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3728 0226
Fax
+98 35 3728 0216
Email
diabet_center@yahoo.com
Web page address
http://www.clinic.ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abargouei
Street address
Vice President of Research and Technology of Shahid Sadoughi University of Medical Sciences, Imam Reza Research Educational Complex, Student Blvd, Imam Hossein Square, Yazd City
City
Yazd
Province
Yazd
Postal code
891618863
Phone
+98 35 3623 8506
Email
dvc.research@ssu.ac.ir
Grant name
Dr. Amin Salehi Abargouei/ Vice Chancellor of Research and Technology, Shahid Sadoughi University of Medical Sciences, Yazd
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Sara Bagherpour
Position
Master student in nutrition science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Alam Square, Yazd City
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2228
Email
sarabagherpour1376@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Sayyed Saeid Khayyatzadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Alam Square, Yazd City
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2228
Email
khayyatzadeh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Sara Bagherpour
Position
Master Student in nutrition science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Alam Square, Yazd City
City
Yazd
Province
Yazd
Postal code
Phone
+98 35 3149 2228
Email
sarabagherpour1376@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
primary outcome will be available at the end of study
When the data will become available and for how long
From January 2024
To whom data/document is available
Academic institutions
Under which criteria data/document could be used
Academic institutes can send their official request to the email of the scientific director of the project. the data will be sent after confirmation of ethics committee of shahid sadoughi university of medical sciences. It is not possible to perform statistical analysis on the data.
From where data/document is obtainable
Sayyed Saeid Khayyatzadeh Assistant professor of nutrition in Shahid Sadoughi university of medical sciences Khayyatzadeh@yahoo.com 00983538209100
What processes are involved for a request to access data/document
Academic institutes can send their official request to the email of the scientific director of the project. The data will be sent after confirmation of ethics committee of Shahid Sadoughi university of medical sciences
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