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IRCT20171226038083N1 IRCT 2019-11-11 Ahvaz University of Medical Sciences lifestyle modification program in pre-diabetic individuals Comparing the effectiveness of an educational intervention based on the determinant of effective and ineffective PRECEDE-PROCEED model on improving self-care quality, glucose control and lifestyle modification of Pre-diabetic persons 2019-01-18 anticipated 242 Complete https://irct.ir/trial/36914 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple Randomization: From 2000 patients with pre-diabetes identified in Hoveyzeh health centers, 242 individuals were selected by Winpepi software. Then, the subjects were randomly divided into intervention and control groups by simple randomization method. The number of intervention and control groups was equal to 121 persons. N/A per-diabetic people. Intervention 1: Based on the needs assessment performed in the previous phase of the study, a lifestyle modification program included: counseling on diet changes, exercise to achieve and maintain ideal body weight, stress management techniques, etc. regularly from training sessions, email and Social networks and SMS will receive. To formulate the content, the World Diabetes Federation Reference Book will be used. This manual is uses for distance education of the HOPE project to obtain PG Certificate in diabetes education.The intervention group received 4 sessions of 60 minutes on one month for the intervention group. The educational content of these 4 sessions consisted of topic importance and problem expression, diet, physical activity and exercise, and stress management. Three months after the end of the training sessions, the intervention group was re-evaluated. Intervention 2: Control group: Only once at the beginning of a regular consultation will receive care according to the country's instructions. 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 The information analysis program is currently designed and does not seem to have applications for third party. However, We will deiced to share/Not to share upon request.
public Meripour Majed
No37, 11 Ave., Imam Reza Blvd., Kianshahr District., Ahwaz Town
Ahwaz Iran (Islamic Republic of) 6445143367 +98 61 3333 3024 Majed8112@gmail.com Ahvaz University of Medical Sciences scientific Khafaie Morteza
Ahvaz Jundishapur University of Medical Sciences., Esfand Ave ., Farvardin Blvd., Golestan Hwy., Ahvaz Town
Ahwaz Iran (Islamic Republic of) 6373125648 +98 61 3111 1111 M.khafaie@live.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Pre-diabetic people Age of 30 to 75 years Resident of Hovizeh 30 years 75 years Both Acute or chronic comorbidities such as mental illness, mental retardation, chronic infectious disease (tb), or motor disability R73.03 Prediabetes Lifestyle N/A Based on the needs assessment performed in the previous phase of the study, a lifestyle modification program included: counseling on diet changes, exercise to achieve and maintain ideal body weight, stress management techniques, etc. regularly from training sessions, email and Social networks and SMS will receive. To formulate the content, the World Diabetes Federation Reference Book will be used. This manual is uses for distance education of the HOPE project to obtain PG Certificate in diabetes education.The intervention group received 4 sessions of 60 minutes on one month for the intervention group. The educational content of these 4 sessions consisted of topic importance and problem expression, diet, physical activity and exercise, and stress management. Three months after the end of the training sessions, the intervention group was re-evaluated. Control group: Only once at the beginning of a regular consultation will receive care according to the country's instructions. Hemoglobin A1c (HbA1c). Timepoint: Starting the study and 3 months later. Method of measurement: we use CERA-STAT 2000 Analyzer (CERAGEM MEDISYS inc). Health-related quality of life (HR-Qol). Timepoint: At the base-line and the end of study (0 and 6-month). Method of measurement: Assessing the Quality of Life of the Diabetic patients by using the World Health Organization (WHO) Quality of Life Questionnaire:. Effect of Intervention. The patient's readiness to change in each of the three areas of the diet, physical activity and stress. Timepoint: Before intervention and after intervention. Method of measurement: A researcher-made questionnaire based on the PRECEDE PROCESS model that will be standardized in the study process. Ahvaz University of Medical Sciences Approved 2018-12-21 The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Golestan Blv. Ahvaz Khouzestan Iran (Islamic Republic of)