]>
IRCT20190518043614N1 IRCT 2019-06-15 Tehran University of Medical Sciences Effect of Self-Care Application on Lifestyle and Laboratory Indices Evaluting the Effect of Self-Care Application on Lifestyle and Laboratory Indicators of client with Non-Alcoholic Fatty Liver disease 2019-06-21 anticipated 70 Complete https://irct.ir/trial/39610 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: Simple randomization done for days of the week with lottery method between the control group (card A) and the intervention group (card B) and available sampling according to entry conditions. N/A Non-Alcoholic Fatty Liver disease. Intervention 1: Control group: After referral of the patient from the gastroenterologist, both the control and intervention groups are examined based on criteria for entering the study and are described the goals of the plan to patients.If the patient wishes to participate in plan, the consent form will be given to sign it after the study. The LSQ Lifestyle Questionnaire is completed the first referral, one , two and three months later by the patient.The educational needs of patients in the field of lifestyle modification are identified, according to the patient's responses to the lifestyle questionnaire and the patient is trained in this cases.Height and weight and body mass index are measured. Patients are referred for testing for ALT, AST, TG, Cholesterol, HDL, LDL, and FBS, Alb, ALKph, CBC, and HOMA indicators before the intervention and 12 weeks after it begins.Educational pamphlet of illness and self-care of non-alcoholic fatty liver is delivered to the patient. Weight and adherence to treatment are assessed on the basis of patients' willingness to attend (clinic) or telephone (first month, weekly, second and third month every two weeks) for 12 weeks. Intervention 2: Intervention group: In addition to the control group actions,The fatty liver self-care application is installed on the patient's phon at first day of the visit which has these parts:1.guide to app 2. Familiarity with non-alcoholic liver disease 3. Self-care assessment and lifestyle education 4. To measure my BMI and calculate BMI. 5. My goal.6. Calories record 7. My weight control 8. My progress 9.contact us. The method of working with the app is taught to the patient. In order to ensure learning, the patient responds to questions by directing the researcher on the self-assessment page. Based on patient responses in every aspect of self care assessment, the app gives the patient an educational feedback. The patient will be asked to read the messages and the lifestyle chart with the color guide is explained to the patient on the app's first page. The patient is asked to focus on his weaknesses in lifestyle modification .The patient enters his height, weight and age on the record page and app is calculated BMI and gives feedback the patient about his weight range.On mygoal page, the patient sets the target weight loss and daily physical activity for one month .The app calculates the patient's daily calorie intake based on the weight loss target in the month.The patient is asked to record on calories page,eaten foods and exercises performed hypothetically.The app gives feedback the patient about the amount of residual daily calorie .Daily allowed , residual, extra and My weight control , My progress and contact us are explained to the patient. To ensure learning is fallowed up with call to patient one, three, and six days after installing the app and the patient is asked to take a photo from the home and calorie record page and send it via WhatsApp.The duration of the intervention is 12 weeks. The patient determines the goal for each month and records daily calories via app and measure the weight weekly and records on my weight control page and sends this page photo via WhatsApp. The first and last day of the targeting, app displays a reminder message on the home page and sends a reminder message every day at 22:00 to record calories. Two motivational messages are sent daily to the patient via the app.An interactive group is formed by WhatsApp messenger between patients and researcher with the aim of sharing questions and experiences of patients and self-care educational materials related to lifestyle modification for improving fatty liver are sent to interactive group for patients daily. The names of the first to fifth individuals in terms of access to the objective of weight loss will be announced in this interactive group to patient motivation. Yes - There is a plan to make this available What will be shared: Lifestyle and results of laboratory indicators are shared. When: Starting the access period from 2020 To whom: Data will be available for scholars from academic and Scientific institutions and people who are involved in the industry and the general public can take action to get them. Conditions: The results of data analysis, such as article and posters, for presentation at seminars and lectures and also these results and application can be used by physicians and healthcare providers and the general public. Where to obtain: Applicants can be contacted by Roya Rahmani(researcher) Address:No994,Nargess Alley37,Qafari Street,Takestan Town,Postal code:3481797994 email:royanrahmani@gmail.com Mobile Phone Number:0098 9127886560 phone number:0098 28 35226264 How to obtain: The applicant can apply for article or application by sending an email or telephone call with researcher. The paper is sent to him for a week .The application is sent to applicant before being commercialized by researcher and the applicant must announce the 6-digit code to the researcher,then the app install code is sent by the researcher to the applicant .After the commercialization of the app, access to the app will be possible to pay the money for researcher. Comments:
public Roya Rahmani
No994,Nargess Ave37,Qafari street,Takestan Town
Takestan Iran (Islamic Republic of) 3481797994 +98 28 3522 6264 r-rahmani@razi.tums.ac.ir Tehran University of Medical Sciences scientific roya rahmani
No994,Nargess Alley37,Qafari Street,Takestan Town
Takeastan Iran (Islamic Republic of) 3481797994 +98 21 3522 6264 r-rahmani@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Diagnosis by specialist physician BMI greater than 25 capability to moderate physical activity Age between 19to 60 years Access to smart phones under the Android capability to work it Informed consent and interest in participating in the study Lack of liver disease such as viral ,autoimmune or medication hepatitis Lack of Wilson, hemochromatosis, hyper or hypothyroidism, diabetes, Addison Lack of gallstone, bile cancer, corticosteroid obesity, Cushing's syndrome Lack of tuberculosis, lipid disorders, alcohol and drug abuse Not using hepatotoxic drugs in the last 6 months, Non-exposure to petrochemicals 19 years 60 years Both Unwillingness to participate in the study Not using self-care app for one month Failure to answer the phone for follow up and no presence in the clinic for two consecutive months K76.0 Fatty (change of) liver, not elsewhere classified Nonalcoholic fatty liver disease [NAFLD] Lifestyle Lifestyle Control group: After referral of the patient from the gastroenterologist, both the control and intervention groups are examined based on criteria for entering the study and are described the goals of the plan to patients.If the patient wishes to participate in plan, the consent form will be given to sign it after the study. The LSQ Lifestyle Questionnaire is completed the first referral, one , two and three months later by the patient.The educational needs of patients in the field of lifestyle modification are identified, according to the patient's responses to the lifestyle questionnaire and the patient is trained in this cases.Height and weight and body mass index are measured. Patients are referred for testing for ALT, AST, TG, Cholesterol, HDL, LDL, and FBS, Alb, ALKph, CBC, and HOMA indicators before the intervention and 12 weeks after it begins.Educational pamphlet of illness and self-care of non-alcoholic fatty liver is delivered to the patient. Weight and adherence to treatment are assessed on the basis of patients' willingness to attend (clinic) or telephone (first month, weekly, second and third month every two weeks) for 12 weeks. Intervention group: In addition to the control group actions,The fatty liver self-care application is installed on the patient's phon at first day of the visit which has these parts:1.guide to app 2. Familiarity with non-alcoholic liver disease 3. Self-care assessment and lifestyle education 4. To measure my BMI and calculate BMI. 5. My goal.6. Calories record 7. My weight control 8. My progress 9.contact us. The method of working with the app is taught to the patient. In order to ensure learning, the patient responds to questions by directing the researcher on the self-assessment page. Based on patient responses in every aspect of self care assessment, the app gives the patient an educational feedback. The patient will be asked to read the messages and the lifestyle chart with the color guide is explained to the patient on the app's first page. The patient is asked to focus on his weaknesses in lifestyle modification .The patient enters his height, weight and age on the record page and app is calculated BMI and gives feedback the patient about his weight range.On mygoal page, the patient sets the target weight loss and daily physical activity for one month .The app calculates the patient's daily calorie intake based on the weight loss target in the month.The patient is asked to record on calories page,eaten foods and exercises performed hypothetically.The app gives feedback the patient about the amount of residual daily calorie .Daily allowed , residual, extra and My weight control , My progress and contact us are explained to the patient. To ensure learning is fallowed up with call to patient one, three, and six days after installing the app and the patient is asked to take a photo from the home and calorie record page and send it via WhatsApp.The duration of the intervention is 12 weeks. The patient determines the goal for each month and records daily calories via app and measure the weight weekly and records on my weight control page and sends this page photo via WhatsApp. The first and last day of the targeting, app displays a reminder message on the home page and sends a reminder message every day at 22:00 to record calories. Two motivational messages are sent daily to the patient via the app.An interactive group is formed by WhatsApp messenger between patients and researcher with the aim of sharing questions and experiences of patients and self-care educational materials related to lifestyle modification for improving fatty liver are sent to interactive group for patients daily. The names of the first to fifth individuals in terms of access to the objective of weight loss will be announced in this interactive group to patient motivation. Lifestyle score is in the Lifestyle Ù‹Questionnaire. Timepoint: Before intervention and one and two and three months after the intervention. Method of measurement: Measurement is done with life style questionnaire which has 32 questions in the Likert spectrum and are scored. always (3), usually (2) or sometimes (1) and never (0) and It has dimensions of physical health and disease prevention, sports and health, weight control and nutrition, psychological health, social health, and the prevention of drugs and drugs. Fasting blood glucose. Timepoint: Before and 12 weeks after the intervention. Method of measurement: Examination of blood patient in laboratory. Blood triglyceride. Timepoint: Before and 12 weeks after the intervention. Method of measurement: Examination of blood patient in laboratory. Blood cholesterol. Timepoint: Before and 12 weeks after the intervention. Method of measurement: Examination of blood patient in laboratory. Blood Alanin aminotransferase. Timepoint: Before and 12 weeks after the intervention. Method of measurement: Examination of blood patient in laboratory. Blood Aspartate aminotransferase. Timepoint: Before and 12 weeks after the intervention. Method of measurement: Examination of blood patient in laboratory. Blood Albumin. Timepoint: Before and 12 weeks after the intervention. Method of measurement: Examination of blood patient in laboratory. Homeostasis model assessment Insulin resistance). Timepoint: Before and 12 weeks after the intervention. Method of measurement: Measurement of fasting serum insulin in the laboratory and it is calculated as fasting insulin (micronutrile bromolitre), multiplied by fasting blood glucose (mgol / liter) divided by 22.5. High density lipoprotein. Timepoint: Before and 12 weeks after the intervention. Method of measurement: Examination of blood patient in laboratory. Low density lipoprotein. Timepoint: Before and 12 weeks after the intervention. Method of measurement: Examination of blood patient in laboratory. Count blood cell. Timepoint: Before and 12 weeks after the intervention. Method of measurement: Examination of blood patient in laboratory. Alkaline Phosphatase. Timepoint: Before and 12 weeks after the intervention. Method of measurement: Examination of blood patient in laboratory. Tehran University of Medical Sciences Approved 2018-09-02 Ethics Committee of the Faculty of Nursing and Midwifery and Rehabilitation Mailbox: 6459(East Nusrat)Dr. Mirkhani Street,Tawhid Square Tehran Tehran Iran (Islamic Republic of)