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IRCT20210808052106N2 IRCT 2023-02-27 National Research Center of Iran Health Insurance Organization Investigating the effect of education in reducing insulin consumption in patients with type 2 diabetes Investigating the effect of teaching self-care behaviors on reducing insulin consumption in patients with type 2 diabetes covered by the health insurance 2023-02-20 anticipated 62 Complete https://irct.ir/trial/68376 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible participants will be randomly assigned to intervention and control groups using random block method by RAS (Random Allocation Software) and 1:1 allocation ratio by a person not involved in the research. In order to hide the allocation of groups based on a random sequence, the allocation is written by a person not involved in the research in terms of numbers on a paper and sealed in a matte envelope. So that the researcher and the analyst will not know about the allocation of groups, Blinding description: In order to hide the allocation of groups based on a random sequence, the allocation is written by a person not involved in the research in terms of numbers on a paper and sealed in a matte envelope. So that the researcher and the analyst will not know about the allocation of groups. N/A Type 2 diabetes. Intervention 1: The group receiving lifestyle, diet and physical activity education. The people of the intervention group will be prescribed a diet containing 60% carbohydrates, 25% fat and 15% protein, 500 kilocalories less than the calculated daily energy, along with general healthy nutrition education based on increasing the consumption of vegetables and legumes and reducing the consumption of sweets and saturated fats. . This group will participate in aerobic exercise for 12 weeks and three sessions per week. The exercise will include brisk walking with 60% heart rate intensity for 45 minutes. The training sessions will include how to inject insulin by a diabetes doctor, healthy nutrition by a nutrition consultant, and physical activity by a sports consultant at the beginning of the study for 6 hours. Intervention 2: Control group: During the study, this group will not receive diet and training, but at the end of the study, a training session along with a lifestyle training brochure will be provided to them. Yes - There is a plan to make this available What will be shared: Part of the data, such as information about the main outcome When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Research using our study from another dimension Where to obtain: Ms. Soraya Moradi Analyst of the study Tel:009851040444 moradi.s@ihio.gov.ir How to obtain: E-mail from the academic researcher and with the authentication of the researcher is possible within one month Comments:
public Leila Javadi
No.35, Rushdieh Alley, Saadi St., Valiasr
Tabriz Iran (Islamic Republic of) 5157936534 +98 41 3333 1633 Javadi.l@ihio.gov.ir Health Insurance Organization scientific Leila Javadi
No.35, Rushdieh Alley, Saadi Ave, valiasr
Tabriz Iran (Islamic Republic of) 5157936534 +98 41 3333 1633 Javadi.l@ihio.gov.ir Health Insurance Organization Iran (Islamic Republic of) Patients with type 2 diabetes should be both men and women in the age range of 35-65 Patients are covered by health insurance 35 years 65 years Both Lack of consent to participate or continue the plan Migration Having mental disorders and movement disorders Having an underlying disease such as debilitating cardiovascular disease E11 Type 2 diabetes mellitus Lifestyle N/A The group receiving lifestyle, diet and physical activity education. The people of the intervention group will be prescribed a diet containing 60% carbohydrates, 25% fat and 15% protein, 500 kilocalories less than the calculated daily energy, along with general healthy nutrition education based on increasing the consumption of vegetables and legumes and reducing the consumption of sweets and saturated fats. . This group will participate in aerobic exercise for 12 weeks and three sessions per week. The exercise will include brisk walking with 60% heart rate intensity for 45 minutes. The training sessions will include how to inject insulin by a diabetes doctor, healthy nutrition by a nutrition consultant, and physical activity by a sports consultant at the beginning of the study for 6 hours. Control group: During the study, this group will not receive diet and training, but at the end of the study, a training session along with a lifestyle training brochure will be provided to them. Fasting blood sugar. Timepoint: The beginning and end of the study. Method of measurement: Spectrophotometric method. Two-hour blood sugar. Timepoint: The beginning and end of the study. Method of measurement: Spectrophotometric method. HbA1c. Timepoint: The beginning and end of the study. Method of measurement: Spectrophotometric method. Pen insulin dosage. Timepoint: The beginning and end of the study. Method of measurement: Electronic prescription system. The average score of anthropometric indices (weight and body mass index) in the study groups. Timepoint: The beginning and end of the study. Method of measurement: Weighed by a Saka scale with an accuracy of 0.1 Kg, height with stadiometer and body mass index are obtained by dividing a person's weight in kilograms by the second power (x²) of his height in meters. National Research Center of Iran Health Insurance Organization Approved 2023-01-09 thics committee of Tabriz University of Medical Sciences NO.35, Roshdie Alley, Saadi Ave, valiasr Tabriz East Azarbaijan Iran (Islamic Republic of)