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IRCT20230104057040N1 IRCT 2023-05-08 Shiraz University of Medical Sciences Nutrition education with extended parallel model in diabetic patients for improving glycemic indices and lipid profile control and adherence to the proper diet Evaluating of the effect of educational intervention based on the developed parallel process model on the adherence to the proper diet, glycemic factors, and lipid profile in middle-aged people with type 2 diabetes 2021-12-22 anticipated 88 Complete https://irct.ir/trial/67816 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Prevention, Randomization description: For data gathering, first, name and address of all health centers of Bowanat city were extracted and from 8 centers, four centers were selected by random multi-stage method. After selecting 4 centers, each center was allocated to a group of intervention or control group by lottery, in order not to let the patients visit each other and not to distort the results. Then, from each center, 22 patients were selected from eligible middle-aged diabetic patients with simple random sampling, Blinding description: the study was single blind. Data analyzer was not also informed of groupings.At the time of analysis, the analyzer was informed that 4 groups with the names of A,B,C,D were available and he/she was not informed of group characteristics. 3 Type 2 Diabetes. Intervention 1: 1- Control group:routine educations for 3 months (82 messages in the form of images and clips, almost 5 messages per day via virtual media such as messengers and by formation of virtual groups). Intervention 2: 1- Intervention group: gain-frame messages group for 3 months (82 messages in the form of images and clips, almost 5 messages per day via virtual media such as messengers and by formation of virtual groups ). Intervention 3: 2- Intervention group:loss-frame messages group for 3 months(78 messages in the form of images and clips, almost 5 messages per day via virtual media such as messengers and by formation of virtual groups). Intervention 4: 3- Intervention group: combined messages group for 3 months (157 messages in the form of images and clips, almost 5 messages per day via virtual media such as messengers and by formation of virtual groups). Yes - There is a plan to make this available What will be shared: The final results will be shared. When: After publishing the article. To whom: Now it is available for the analyzer and the main investigators. Conditions: Only with permission from the investigator Where to obtain: By contacting the investigator How to obtain: By asking from e-mail (email address: Sohrabi@sums.ac.ir) Comments:
public Tayebe Dehghan
Razi avenue
Shiraz Iran (Islamic Republic of) ۱۴۳۳۶۷۱۳۴۸ +98 917 566 2643 dehghant89@yahoo.com Shiraz University of Medical Sciences scientific Zahra Sohrabi
Razi avenue
Shiraz Iran (Islamic Republic of) ۱۴۳۳۶۷۱۳۴۸ +98 917 711 3086 Zahra_2043@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age range: 30-59 years old (middle age) Having type 2 diabetes and not using insulin (FBS higher than 125 and 2-hr glucose higher than 200 mg/dl) Not having chronic diseases including cancer, kidney or liver diseases Not using special drugs, not smoking Having no special diet Not being pregnant or lactating 30 years 59 years Both Incidence of any chronic or acute diseases or incidence of some diseases such as kidney diseases Sudden disturbances of blood glucose including sudden and dangerous hypo- or hyperglycemia Acute or respiratory infections Any surgery Following any special diet or physical activity regiment Prevention Prevention Prevention Prevention 1- Control group:routine educations for 3 months (82 messages in the form of images and clips, almost 5 messages per day via virtual media such as messengers and by formation of virtual groups) 1- Intervention group: gain-frame messages group for 3 months (82 messages in the form of images and clips, almost 5 messages per day via virtual media such as messengers and by formation of virtual groups ) 2- Intervention group:loss-frame messages group for 3 months(78 messages in the form of images and clips, almost 5 messages per day via virtual media such as messengers and by formation of virtual groups) 3- Intervention group: combined messages group for 3 months (157 messages in the form of images and clips, almost 5 messages per day via virtual media such as messengers and by formation of virtual groups) Glycosylated hemoglobin. Timepoint: At baseline and after 3 months. Method of measurement: High performance liquid chromatography (HPLC). Fasting blood glucose. Timepoint: At baseline and after 3 months. Method of measurement: Calorimetric method by using auto-analyzer. 2 hour- blood glucose. Timepoint: At baseline and after 3 months. Method of measurement: Calorimetric method by using auto-analyzer. Low density lipoprotein-cholestrol. Timepoint: At baseline and after 3 months. Method of measurement: Calorimetric method by using auto-analyzer. High density lipoprotein-cholestrol. Timepoint: At baseline and after 3 months. Method of measurement: Calorimetric method by using auto-analyzer. Total cholestrol. Timepoint: At baseline and after 3 months. Method of measurement: Calorimetric method by using auto-analyzer. Triglyceride. Timepoint: At baseline and after 3 months. Method of measurement: Calorimetric method by using auto-analyzer. Weight. Timepoint: At baseline and after 3 months. Method of measurement: With scale. Height. Timepoint: At baseline and after 3 months. Method of measurement: With tape meter. Body mass index. Timepoint: At baseline and after 3 months. Method of measurement: With calculation from weight and height. Waist circumference. Timepoint: At baseline and after 3 months. Method of measurement: With tape meter. Hip circumference. Timepoint: At baseline and after 3 months. Method of measurement: With tape meter. Waist to hip ratio. Timepoint: At baseline and after 3 months. Method of measurement: Calculate form waist and hip measurements. Physical activity. Timepoint: At baseline and after 3 months. Method of measurement: With questionnaire. Knowledge level. Timepoint: At baseline and after 3 months. Method of measurement: With questionnaire. Perceived sensitivity. Timepoint: At baseline and after 3 months. Method of measurement: With questionnaire. Perceived severity. Timepoint: At baseline and after 3 months. Method of measurement: With questionnaire. Perceived effectiveness. Timepoint: At baseline and after 3 months. Method of measurement: With questionnaire. Self-efficacy. Timepoint: At baseline and after 3 months. Method of measurement: With questionnaire. Intention. Timepoint: At baseline and after 3 months. Method of measurement: With questionnaire. Food intake of macro nutrients and calorie. Timepoint: 3-day dietary recall. Method of measurement: With questionnaire. Shiraz University of Medical Sciences Approved 2021-07-18 Shiraz University of Medical Sciences Razi Avenue Shiraz Fars Iran (Islamic Republic of)