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IRCT201701165670N23 IRCT 2017-05-20 Vice-Dean for Reserch and Technology Tabriz University Of Medical Science Diabetes Education ٍEffect application of the transtheoretical model self-care outcomes and serum irisin level in the patients with type 2 diabetes and control. 2016-12-13 anticipated 134 Complete https://irct.ir/trial/6195 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A diabetes. Intervention 1: Control group: During the intervention and six-month follow-up, the control group will not receive training program and after the end of study pamphlets and videos teaching demo will be available to them. Intervention 2: Intervention group: The intervention group will be trans-theoretical model of education based on stages of change model. Educational content for people who pre contemplation, contemplation and decision are: In training sessions for each of the people who are in pre- contemplation the content of education separately, for those who are contemplation stage the content of education separately, for those who are decision stage individually tailored education content and to people based on location will be trained in each of the steps. Training healthy lifestyle will be given (proper use of blood glucose lowering drugs, healthy diet and proper physical activity), short-term and long-term complications caused by poor control of blood glucose and the effects of diet and physical activity on control of blood glucose. Also at the meeting discussed the results of a group and motivational interviews (attention, relevance, confidence and satisfaction) will be used in the decision stage. After people during each stage of their education and arrived to action and maintenance, The next steps will be implemented in the following explained. Educational content for people who are action and maintenance: Self-care educational content sessions • educational content, blood glucose lowering drugs: Proper education about using medication, side effects of blood glucose lowering drugs, Introduction to Herbal Medicines lowering blood sugar training will be given using a video projector. • Educational content diet education sessions: In training sessions diet for people with diabetes, about food groups, my plate, food serving, carbohydrate, protein and fat, glycemic parameters and their effects on weight and also improperly cooked food and how to choose and buy food according to food groups and healthy cooking food, use artificial sweeteners and fats and salts in moderation will be given the necessary training using video projector. • The contents of sessions of physical activity: In people with type 2 diabetes in sessions of physical activity, aerobic exercise (walking, swimming, gardening and light aerobic exercises) the average duration and intensity resistance exercise with an interval of half an hour three times a week according to the stage of change model training process will be broadcast using video projector and training will be given to them. this means that people who are pre contemplation stage educational content and dramatic film - individually according to your needs and learning from educational content specified ,as well as for people who are in the process of contemplation, decision, action and maintaining improper behavior educational content and dramatic film - a separate training according to the needs and from the educational content of self-care, proper education about using medication lowering blood sugar, diet education and training physical activity The qualitative study with content that will be used in decision stage, Will be taught. training period will be 7 week, during the seven-week training session Will be held on the basis of stages of change and the number of patients' needs in meetings an hour to 2 hours, group training for the lecture with questions and answers and the explanations. Tools video projector will be used for education, some of the meetings will be formed accompanied by an influential family members, in the last session and a summary of their training Care and dramatic film - made training to people involved displayed and educational tool CD containing demo videos - training will be provided to subjects, after 7 weeks of primary and secondary outcomes will be measured and will follow-up 6-month and in six months there will be no intervention And again six months after the primary and secondary outcomes will be measured.
public Maryam Zare
Ardibil
Ardibil Iran (Islamic Republic of) +98 45 3326 0575 mzare753@gmail.com Nutrition faculty, Tabriz university Of Medical sciences scientific Dr.Ali Tarighat-Esfanjani
Nutrition Faculty, Attarneyshabouri street, Golgasht street
Tabriz Iran (Islamic Republic of) +98 41 3335 7310 tarighata@tbzmed.ac.ir Nutrition Faculty, Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: patients with type 2 diabetes, age range 30-70 years; patients with type 2 diabetes with a history of over a year; the use of blood glucose lowering drugs ;Satisfaction in the study; absence of kidney disease, liver and mental problems and learning, vision and hearing problems; A1C ≥ 7% or FPG≥ 126 mg / dL ; BMI>25 kg/m2 ;ability to read and write; regular attendance in classes Exclusion criteria: the use of insulin in patients with type 2 diabetes; pregnant women with type 2 diabetes / plan to become pregnant or breast-feeding; Persons who have already passed the training course healthy lifestyle as a model; patients who were undergoing surgery for weight loss. 30 years 70 years Both E11 Non-insulin-dependent diabetes mellitus Lifestyle Lifestyle Control group: During the intervention and six-month follow-up, the control group will not receive training program and after the end of study pamphlets and videos teaching demo will be available to them Intervention group: The intervention group will be trans-theoretical model of education based on stages of change model. Educational content for people who pre contemplation, contemplation and decision are: In training sessions for each of the people who are in pre- contemplation the content of education separately, for those who are contemplation stage the content of education separately, for those who are decision stage individually tailored education content and to people based on location will be trained in each of the steps. Training healthy lifestyle will be given (proper use of blood glucose lowering drugs, healthy diet and proper physical activity), short-term and long-term complications caused by poor control of blood glucose and the effects of diet and physical activity on control of blood glucose. Also at the meeting discussed the results of a group and motivational interviews (attention, relevance, confidence and satisfaction) will be used in the decision stage. After people during each stage of their education and arrived to action and maintenance, The next steps will be implemented in the following explained. Educational content for people who are action and maintenance: Self-care educational content sessions • educational content, blood glucose lowering drugs: Proper education about using medication, side effects of blood glucose lowering drugs, Introduction to Herbal Medicines lowering blood sugar training will be given using a video projector. • Educational content diet education sessions: In training sessions diet for people with diabetes, about food groups, my plate, food serving, carbohydrate, protein and fat, glycemic parameters and their effects on weight and also improperly cooked food and how to choose and buy food according to food groups and healthy cooking food, use artificial sweeteners and fats and salts in moderation will be given the necessary training using video projector. • The contents of sessions of physical activity: In people with type 2 diabetes in sessions of physical activity, aerobic exercise (walking, swimming, gardening and light aerobic exercises) the average duration and intensity resistance exercise with an interval of half an hour three times a week according to the stage of change model training process will be broadcast using video projector and training will be given to them. this means that people who are pre contemplation stage educational content and dramatic film - individually according to your needs and learning from educational content specified ,as well as for people who are in the process of contemplation, decision, action and maintaining improper behavior educational content and dramatic film - a separate training according to the needs and from the educational content of self-care, proper education about using medication lowering blood sugar, diet education and training physical activity The qualitative study with content that will be used in decision stage, Will be taught. training period will be 7 week, during the seven-week training session Will be held on the basis of stages of change and the number of patients' needs in meetings an hour to 2 hours, group training for the lecture with questions and answers and the explanations. Tools video projector will be used for education, some of the meetings will be formed accompanied by an influential family members, in the last session and a summary of their training Care and dramatic film - made training to people involved displayed and educational tool CD containing demo videos - training will be provided to subjects, after 7 weeks of primary and secondary outcomes will be measured and will follow-up 6-month and in six months there will be no intervention And again six months after the primary and secondary outcomes will be measured. Fasting blood glucose (FPG). Timepoint: Before intervention At the end of the seventh week and 6 months after the intervention. Method of measurement: Photometry with Commercial Kits (Pars azmon). Glycosylated hemoglobin(A1C). Timepoint: Early intervention, the end of the seventh week and after 6 months follow-up. Method of measurement: Chromatography. Blood glucose 2 hours after breakfast( 2-h PG). Timepoint: Early intervention, the end of the seventh week and after 6 months follow-up. Method of measurement: Photometry with Commercial Kits (Pars Azmoon). Tri glyceride(TG). Timepoint: Early intervention, the end of the seventh week and after 6 months follow-up. Method of measurement: Photometry with Commercial Kits (Pars Azmoon). Total Cholesterol(TC). Timepoint: Early intervention, the end of the seventh week and after 6 months follow-up. Method of measurement: Photometry with Commercial Kits (Pars Azmoon). HDL-C. Timepoint: Early intervention, the end of the seventh week and after 6 months follow-up. Method of measurement: Photometry with Commercial Kits (Pars Azmoon). LDL–C. Timepoint: Early intervention, the end of the seventh week and after 6 months follow-up. Method of measurement: Fried-Wald formula. Irisin. Timepoint: Early intervention, the end of the seventh week and after 6 months follow-up. Method of measurement: ELISA kit for measuring enzyme-linked immunosorbent (Zlbio, Germany). Serum insulin. Timepoint: Early intervention, the end of the seventh week and after 6 months follow-up. Method of measurement: ELISA kit for measuring enzyme-linked immunosorbent (monobind, America ). Betatrophin. Timepoint: Early intervention, the end of the seventh week and after 6 months follow-up. Method of measurement: ELISA kit for measuring enzyme-linked immunosorbent (Zlbio, Germany). Weight. Timepoint: Before the intervention, the end of the seventh week and after 6 months follow-up. Method of measurement: scale RASA. Body mass index(BMI). Timepoint: Before the intervention, the end of the seventh week and after 6 months follow-up. Method of measurement: With formula. Blood Pressure. Timepoint: Before the intervention, the end of the seventh week and after 6 months follow-up. Method of measurement: Manometer EmsiG. The type and number of drugs. Timepoint: Before the intervention, the end of the seventh week and after 6 months follow-up. Method of measurement: With Question. Position on Stage of Change. Timepoint: Before the intervention, the end of the seventh week and after 6 months follow-up. Method of measurement: Questionnaire Stage of Change. Energy. Timepoint: Before the intervention, the end of the seventh week and after 6 months follow-up. Method of measurement: Recall Food 24 -hour. Macronutrients. Timepoint: Before the intervention, the end of the seventh week and after 6 months follow-up. Method of measurement: Recall Food 24 -hour. Exercise Intensity. Timepoint: Before the intervention, the end of the seventh week and after 6 months follow-up. Method of measurement: Questionnaire IPAQ. Exercise Duration. Timepoint: Before the intervention, the end of the seventh week and after 6 months follow-up. Method of measurement: Questionnaire IPAQ. Exercise Frequency. Timepoint: Before the intervention, the end of the seventh week and after 6 months follow-up. Method of measurement: Questionnaire IPAQ. Vice-Dean for Reserch and Technology Tabriz University Of Medical Science Approved 2016-12-26 Vice-Dean for Reserch and Technology Tabriz University of Medical Sciences GOLGASHT Street;Tabriz Tabriz Iran (Islamic Republic of)