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IRCT20190303042901N1 IRCT 2020-10-28 Vice Chancellor for Research, Arak University of Medical Sciences The Effect of Theory-Based Education on Carbohydrate Consumption Behavior in Type 2 Diabetic Patients CIBDM The effect of education based on health belief model on behavior related to carbohydrate consumption in type 2 diabetic patients referred to comprehensive health service centers in Arak in 2019 2019-07-23 anticipated 80 Complete https://irct.ir/trial/41021 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: The present study is a control educational trial on about 80 patients with type 2 diabetes referred to the comprehensive health service centers in Arak (40 people in the two experimental and control groups). The method of selecting individuals was performed using the multi-stage method. In the first stage, the residents of Arak city are divided into four categories according to the opinion of the health deputy staff based on the socio-economic status. These four classes include centers with covered populations with relatively good, average, low-average, and poor economic status. Then, two health centers from each category were selected at random, so that the first selected center belongs to the experimental group and the second selected center belongs to the control group, so a total of 4 centers were assigned to the experimental group and 4 centers to the control group. In the second step, samples are randomly selected from each center. In order to perform a simple random method, a list of type 2 diabetic patients who are registered in the Apple system and are covered by that health center to receive care, is prepared in each center and then randomly we selected people from the list of type 2 diabetic patients registered in that health center. The number of samples selected from each center is 10 people in each group. N/A Diabetes Mellitus. Intervention 1: Intervention group: Pre-test by distributing a standard questionnaire and determining the level of knowledge, sensitivity, severity, perceived benefits and barriers, internal and external practice guides, self-efficacy and performance on carbohydrate consumption behavior before the intervention for case and control groups, then Evaluation of blood levels of HbA1c, FBS and BMI before interventionIn the next stage, conducting an educational intervention based on cross-sectional study and finally post-test by redistributing the questionnaire and determining the level of knowledge, sensitivity, severity, benefits and perceived barriers and action guides on carbohydrate consumption behavior for case and control groups. In 3 months after the educational intervention and examination of HbA1c, FBS and BMI levels after the interventionTo compare the mean score of knowledge, sensitivity, severity, perceived benefits and barriers and self-efficacy and practice guidelines on carbohydrate consumption behavior in the case and control groups, parametric tests such as independent t-test and paired t-test are used. Tests and include non-parametric tests such as Kruskal-Wallis, Wilcoxon, Mann-Whitney, and Spearman correlation tests. Intervention 2: Control group: 1- Sample selection 2- Pre-test by distributing a standard questionnaire and determining the level of knowledge, sensitivity, severity, perceived benefits and barriers, internal and external practice guides, self-efficacy and performance regarding behavior related to carbohydrate consumption in Control group.3-Assessment of HbA1c, FBS and BMI levels - Post-test by redistributing the questionnaire and determining the level of knowledge, sensitivity, severity, perceived benefits and barriers and action guides on carbohydrate consumption behavior for the control group in 3 months Examination of HbA1c, FBS and BMI levels and retesting 3 months later to compare means in individuals who have not undergone educational intervention. Yes - There is a plan to make this available What will be shared: Some of the data such as information about the main outcome and model structures can be shared. When: Start of access period from 1400 and 6 months after printing the results To whom: For all academics and diabetics Conditions: If the source is mentioned, its use is unrestricted Where to obtain: Website and postal address and e-mail of the responsible author Ms. Mahboubeh Khorsandi How to obtain: By requesting the e-mail, the responsible author can access the requested items after a complete review. Comments:
public Mahboubeh Khorsandi
Building No. 2, Arak University of Medical Sciences, Golestan Alley, Mostafa Khomeini Complex
Arak Iran (Islamic Republic of) 3818146851 +98 86 3368 6443 dr.khorsandi@arakmu.ac.ir Arak University of Medical Sciences scientific Mahboubeh Khorsandi
Department of Health Education, Faculty of Health, Arak University of Medical Sciences, Arak, Iran.
Arak Iran (Islamic Republic of) 3818146851 +98 86 3368 6443 dr.khorsandi@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Type 2 diabetic patients aged 60 to 30 years old Type 2 diabetic patients with at least 5 reading and writing classes Patients with type 2 diabetes who have chronic diabetes complications, such as retinopathy, nephropathy, neuropathy, etc., will be identified by examining patients' medical records Type 2 diabetic patients who live in Arak are included in the study Type 2 diabetic patients taking oral medications Type 2 diabetic patients who have been diagnosed with diabetes for at least one year Type 2 diabetic patients who do not use a specific diet 30 years 60 years Both If the patient is reluctant to continue to cooperate If the patient migrates from Arak Continuous absence of diabetic patients at training sessions (overtime absences (half sessions) in educational intervention sessions) Unavailability of patients when completing a post-test questionnaire If patients have any of the complications of diabetes Change the drug program (from the oral to the injectable form) and the use of diet during the program that leads to changes in the patient's diet plan E08 Diabetes mellitus due to underlying condition Behavior Behavior Intervention group: Pre-test by distributing a standard questionnaire and determining the level of knowledge, sensitivity, severity, perceived benefits and barriers, internal and external practice guides, self-efficacy and performance on carbohydrate consumption behavior before the intervention for case and control groups, then Evaluation of blood levels of HbA1c, FBS and BMI before interventionIn the next stage, conducting an educational intervention based on cross-sectional study and finally post-test by redistributing the questionnaire and determining the level of knowledge, sensitivity, severity, benefits and perceived barriers and action guides on carbohydrate consumption behavior for case and control groups. In 3 months after the educational intervention and examination of HbA1c, FBS and BMI levels after the interventionTo compare the mean score of knowledge, sensitivity, severity, perceived benefits and barriers and self-efficacy and practice guidelines on carbohydrate consumption behavior in the case and control groups, parametric tests such as independent t-test and paired t-test are used. Tests and include non-parametric tests such as Kruskal-Wallis, Wilcoxon, Mann-Whitney, and Spearman correlation tests. Control group: 1- Sample selection 2- Pre-test by distributing a standard questionnaire and determining the level of knowledge, sensitivity, severity, perceived benefits and barriers, internal and external practice guides, self-efficacy and performance regarding behavior related to carbohydrate consumption in Control group.3-Assessment of HbA1c, FBS and BMI levels - Post-test by redistributing the questionnaire and determining the level of knowledge, sensitivity, severity, perceived benefits and barriers and action guides on carbohydrate consumption behavior for the control group in 3 months Examination of HbA1c, FBS and BMI levels and retesting 3 months later to compare means in individuals who have not undergone educational intervention. Performance. Timepoint: At the beginning of the study and 3 months after. Method of measurement: Questionnaire. Knowledge. Timepoint: At the beginning of the study and 3 months after. Method of measurement: Questionnaire. Perceived sensitivity. Timepoint: At the beginning of the study and 3 months after. Method of measurement: Questionnaire. Perceived severity. Timepoint: At the beginning of the study and 3 months after. Method of measurement: Questionnaire. Perceived benefits. Timepoint: At the beginning of the study and 3 months after. Method of measurement: Questionnaire. Perceived barriers. Timepoint: At the beginning of the study and 3 months after. Method of measurement: Questionnaire. Internal action guide. Timepoint: At the beginning of the study and 3 months after. Method of measurement: Questionnaire. External action guide. Timepoint: At the beginning of the study and 3 months after. Method of measurement: Questionnaire. Efficacy. Timepoint: At the beginning of the study and 3 months after. Method of measurement: Questionnaire. Determining the behavior carbohydrate consumption. Timepoint: At the beginning of the study and 3 months after. Method of measurement: questionnaire. Check the level of FBS blood index. Timepoint: At the beginning of the study and 3 months after. Method of measurement: Blood test is determined in the laboratory and with a device. Check the level of HbA1c blood index. Timepoint: At the beginning of the study and 3 months after. Method of measurement: Blood sampling using CERA-STAT 2000 Analyzer manufactured by Korean company CERAGEM MEDISYS. Measuring BMI. Timepoint: At the beginning of the study and 3 months after. Method of measurement: Meters and scales. Vice Chancellor for Research, Arak University of Medical Sciences Approved 2019-05-31 Ethics committee of Arak University of Medical Sciences Arak University of Medical Sciences, Payambar Azam University Complex, Basij Square, Sardasht arak Markazi Iran (Islamic Republic of)