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IRCT20211018052796N1 IRCT 2022-04-09 Shooshtar University of Medical Sciences The effect of family-centered empowerment model on adherence to the diet regimen of elderly patients with type II diabetes The effect of the family-centered empowerment model on adherence to the diet regimen of elderly patients with type II diabetes mellitus 2021-10-26 anticipated 148 Complete https://irct.ir/trial/59588 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Elderly people with type 2 diabetes who were eligible for the study are collected from patients referred to clinics in Shoushtar city in such a way that based on the duration of the disease, age, and sex, the groups are matched and randomly divided into two groups: control and Interventions are placed. Randomization will be carried out using a random number table generated by Excel software and participants will be randomly allocated to one of the two groups. The control group will receive face-to-face education and the intervention groups will receive a 12-week nutrition education intervention in addition to face-to-face education. N/A Type 2 diabetes. Intervention group: Appropriate diet will be taught by a nutritionist and during nutrition counseling sessions according to the disease status and other underlying diseases of the participants. In these sessions, patients will be taught the glycemic index and glycemic load of carbohydrate foods. You will also be taught how to choose, cook, and process carbohydrate-rich foods to help control your blood sugar levels. It consists of 20 points and is divided into good, medium and poor levels. Will be used and the HbA1C index will be used as a follow-up to the diet, which will be recorded for all samples. For the intervention group, the family-centered empowerment model in four steps; Perceived threat, self-efficacy, self-esteem and evaluation, through group training, group problem solving and training participation, will take place during 3-5 sessions of 30 minutes per week in one of the faculty classes and training cards and training booklets are available. Research and will be an active member of their family. The control group will receive routine care. Patients' competency indicators (perceived threat, self-efficacy and self-esteem) are assessed before the intervention and after the intervention and three months later, but no intervention will be performed in the control group. Leha will act face to face with the patient; and in the same session, the empowerment questionnaire of the active family member will be completed by themselves in the presence of the researcher and if the researcher has a question, after analyzing the data related to the pre-test, intervention in Three steps will be performed for the experimental group in groups of 3-5 people. In the first step, "perceived threat" sessions aimed at increasing the perceived threat by increasing their level of knowledge and awareness about the problems that threaten the patient and the problems and In the first and second sessions, the researcher will explain the nature and process of the disease and its prognosis, the symptoms and the possibility of complications and its consequences, and prevention and treatment strategies, medication regimen, and follow-up treatment plan. The participants themselves continue the discussion and discuss in order to continue learning Training cards will also be used outside of these sessions. Patients will be given educational cards with explanations in simple language and illustrative images in each session related to the topic of discussion. In the second step (self-efficacy through problem-solving), the patient actively participates in the care program while being aware of and deeply aware of the disease process and its complications with confidence and feeling that I can play a role in improving my condition. Problem-solving sessions will be held and problems and problems related to the disease will be discussed through group discussions, such as the correct use of the glucometer. In the third step (self-esteem), the patient was asked to participate in the training of an active family member by conveying the material discussed in each session to the active family member on behalf of the family, and in addition For each session, educational cards will be sent by the researcher to the active member of the family, which contains content and illustrations in plain language and two related questions on the back of the cards. Intervention and final evaluation three months after the intervention through The questionnaire will be implemented. At the end of the work, ie about three months, the awareness questionnaire will be completed again by both groups. The HbA1C of both groups will be measured. They will be analyzed after data collection.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Elham Abdolahi Shahvali
Khozestan, Shoushtar, Shahid Rajaei Crossroads, in front of Hosseinieh Azam, Alhadi Hospital, Vice Chancellor for Research and Student Culture.
Shoushtar Iran (Islamic Republic of) 6451684534 +98 61 3621 5755 eabdolahi31@yahoo.com Shooshtar University of Medical Sciences scientific Shirin Amini
Khozestan, Shoushtar, Shahid Rajaei Crossroads, in front of Hosseinieh Azam, Alhadi Hospital, Vice Chancellor for Research and Student Culture.
Shoushtar Iran (Islamic Republic of) 6451684534 +98 61 3621 5755 aminishirin83@yahoo.com Shooshtar University of Medical Sciences Iran (Islamic Republic of) Informed consent, an active member of the patient's family and access to the Internet and mobile phone, more than three months of the disease, age 50 50 years no limit Both Failure to complete a questionnaire for mental disorders, hospitalization due to other health problems Lifestyle Intervention group: Appropriate diet will be taught by a nutritionist and during nutrition counseling sessions according to the disease status and other underlying diseases of the participants. In these sessions, patients will be taught the glycemic index and glycemic load of carbohydrate foods. You will also be taught how to choose, cook, and process carbohydrate-rich foods to help control your blood sugar levels. It consists of 20 points and is divided into good, medium and poor levels. Will be used and the HbA1C index will be used as a follow-up to the diet, which will be recorded for all samples. For the intervention group, the family-centered empowerment model in four steps; Perceived threat, self-efficacy, self-esteem and evaluation, through group training, group problem solving and training participation, will take place during 3-5 sessions of 30 minutes per week in one of the faculty classes and training cards and training booklets are available. Research and will be an active member of their family. The control group will receive routine care. Patients' competency indicators (perceived threat, self-efficacy and self-esteem) are assessed before the intervention and after the intervention and three months later, but no intervention will be performed in the control group. Leha will act face to face with the patient; and in the same session, the empowerment questionnaire of the active family member will be completed by themselves in the presence of the researcher and if the researcher has a question, after analyzing the data related to the pre-test, intervention in Three steps will be performed for the experimental group in groups of 3-5 people. In the first step, "perceived threat" sessions aimed at increasing the perceived threat by increasing their level of knowledge and awareness about the problems that threaten the patient and the problems and In the first and second sessions, the researcher will explain the nature and process of the disease and its prognosis, the symptoms and the possibility of complications and its consequences, and prevention and treatment strategies, medication regimen, and follow-up treatment plan. The participants themselves continue the discussion and discuss in order to continue learning Training cards will also be used outside of these sessions. Patients will be given educational cards with explanations in simple language and illustrative images in each session related to the topic of discussion. In the second step (self-efficacy through problem-solving), the patient actively participates in the care program while being aware of and deeply aware of the disease process and its complications with confidence and feeling that I can play a role in improving my condition. Problem-solving sessions will be held and problems and problems related to the disease will be discussed through group discussions, such as the correct use of the glucometer. In the third step (self-esteem), the patient was asked to participate in the training of an active family member by conveying the material discussed in each session to the active family member on behalf of the family, and in addition For each session, educational cards will be sent by the researcher to the active member of the family, which contains content and illustrations in plain language and two related questions on the back of the cards. Intervention and final evaluation three months after the intervention through The questionnaire will be implemented. At the end of the work, ie about three months, the awareness questionnaire will be completed again by both groups. The HbA1C of both groups will be measured. They will be analyzed after data collection. HBA1C index. Timepoint: Before the start of the training and three months after the training. Method of measurement: Check the percentage of HBA1C. Diet adherence. Timepoint: Before the start of training and three months after. Method of measurement: Completion of the questionnaire. Shooshtar University of Medical Sciences Approved 2021-02-09 Shoushtar Faculty of Medical Sciences Khozestan, Shoushtar, Shahid Rajaei Crossroads, in front of Hosseinieh Azam, Alhadi Hospital, Vice Chancellor for Research and Student Culture. shoushtar Khouzestan Iran (Islamic Republic of)