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IRCT20220222054091N1 IRCT 2022-12-07 Tabriz University of Medical Sciences The effectiveness of a text message intervention on obesity in women with polycystic ovarian syndrome The effectiveness of a text message intervention on obesity-related parameters in obese or overweight women with polycystic ovarian syndrome: a randomized controlled clinical trial 2022-12-26 anticipated 124 Complete https://irct.ir/trial/62096 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The participants are assigned to the intervention and control groups by block randomization with a block size of 4 and 6 and with 1:1 allocation. For Allocation Concealment, the group name will be written on paper and placed inside numbered opaque envelopes. The envelopes will be opened in the order of participants entering the study and the group of participants will be determined. The randomization and preparation of envelopes will be done by someone who is not involved in sampling and data collection. N/A Condition 1: obesity or overweight. Condition 2: polycystic ovary syndrome. Intervention 1: Intervention group: Educational brochures at the begining of study and educational text messages about the importance of weight loss on the clinical symptoms of polycystic ovary syndrome, recommendations about healthier food choices and physical activity. The brochures are provided to all participants at the beginning of the study and include general information about polycystic ovary syndrome and the importance of weight loss in this disease. text messages are sent twice a week for 6 months to the study group, and participants will be asked to pay attention to these texts, read and follow them if possible. The content of the messages will be written using scientific papers, physical activity and healthy diet guidelines published by the World Health Organization and other standard sources. The content of the messages will be reviewed and approved by specialists in nutrition, sports medicine, gynecologist, social physician and psychologist. Intervention 2: Control group: Educational brochures about the importance of weight loss on the clinical symptoms of polycystic ovary syndrome, recommendations about healthier food choices and physical activity. The brochures are provided to all participants at the beginning of the study and include general information about polycystic ovary syndrome and the importance of weight loss in this disease. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after making individuals unidentifiable When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: By observing the principle of intellectual property and without making any changes or misapplication Where to obtain: Scientific respondent to the study E-mail :alizadm@yahoo.com Dr. Mahasti Alizadeh mizani How to obtain: Will be answered in less than two weeks Comments:
public mahasti alizadeh mizani
2nd Floor, Social Determinants of Health Research Center, Central Library of Tabriz University of Medical Sciences, University of Tabriz Campus, Daneshgah St., Tabriz, Iran
tabriz Iran (Islamic Republic of) 5166614766 +98 41 3177 2334 alizadm@yahoo.com Tabriz University of Medical Sciences scientific mahasti alizadeh mizani
2nd Floor, Social Determinants of Health Research Center, Central Library of Tabriz University of Medical Sciences, University of Tabriz Campus, Daneshgah St., Tabriz, Iran
tabriz Iran (Islamic Republic of) 5166614766 +98 41 3177 2334 alizadm@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) women with polycystic ovarian syndrome BMI more than 25 fertility age a desire to lose weight 15 years 45 years Female Not having a mobile phone Use of weight loss medication Having other metabolic diseases such as diabetes or thyroid disorders E66 E28.2 Overweight and obesity Polycystic ovarian syndrome Lifestyle Lifestyle Intervention group: Educational brochures at the begining of study and educational text messages about the importance of weight loss on the clinical symptoms of polycystic ovary syndrome, recommendations about healthier food choices and physical activity. The brochures are provided to all participants at the beginning of the study and include general information about polycystic ovary syndrome and the importance of weight loss in this disease. text messages are sent twice a week for 6 months to the study group, and participants will be asked to pay attention to these texts, read and follow them if possible. The content of the messages will be written using scientific papers, physical activity and healthy diet guidelines published by the World Health Organization and other standard sources. The content of the messages will be reviewed and approved by specialists in nutrition, sports medicine, gynecologist, social physician and psychologist. Control group: Educational brochures about the importance of weight loss on the clinical symptoms of polycystic ovary syndrome, recommendations about healthier food choices and physical activity. The brochures are provided to all participants at the beginning of the study and include general information about polycystic ovary syndrome and the importance of weight loss in this disease. Body weight. Timepoint: At the beginning of the study, after 3 months and 6 months of intervention. Method of measurement: Weighing scale. Waist circumference. Timepoint: At the beginning of the study, after 3 months and 6 months of intervention. Method of measurement: tape measure. Average physical activity. Timepoint: At the beginning of the study, after 3 months and 6 months of intervention. Method of measurement: International Physical Activity Questionnaire. Diet. Timepoint: At the beginning of the study, after 3 months and 6 months of intervention. Method of measurement: 3-day food records questionnaire. Appetite. Timepoint: At the beginning of the study, after 3 months and 6 months of intervention. Method of measurement: appetite questionnaire. Hip circumference. Timepoint: At the beginning of the study, after 3 months and 6 months of intervention. Method of measurement: tape measure. Body mass index. Timepoint: At the beginning of the study, after 3 months and 6 months of intervention. Method of measurement: weight in kilograms divided by height in meters squared. Tabriz University of Medical Sciences Approved 2022-10-31 Ethics Committee Of Tabriz University Of Medical Sciences Third Floor, Central Building Number 2, Golgasht Street tabriz East Azarbaijan Iran (Islamic Republic of)