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IRCT20201129049526N1 IRCT 2020-12-07 application for fund was done and still awaiting approval A healthy diet and premenstrual syndrome Effects of healthy diet in reducing symptoms of premenstrual syndrome and improving quality of life among Omani Adolescents; a randomized controlled open label trial 2021-02-01 anticipated 70 Complete https://irct.ir/trial/52660 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Consecutive or random sampling using computer-generated random number table will be used for the recruitment stage, depending on the prevalence rate of PMS (i.e if the prevalence is high, random sampling will be applied, whereas consecutive sampling will be utilized if there is a limited number of adolescents with PMS). Cluster randomization of schools will be carried to minimize contamination anticipated from recruiting subjects from the same school. Therefore, the intervention and control groups will be derived from different schools. 3 premenstrual syndrome. Intervention 1: Intervention group :Subjects in the intervention group will receive an individual face-to-face dietary consultation by a well-experienced dietician. She will educate the participants about the importance of healthy diet, evaluate the baseline dietary habits of each participant and give advice on how to modify them. The healthy diet advice is derived from the food-based dietary guidelines (FBDG) that were proposed for Omani adolescents (24). FBDG for Omani adolescents includes a daily intake of the following: i) carbohydrates (330-450 g), ii) protein (48-60 g), iii) fibers (19-48 g), iv) energy (2400 lcal), v) calcium (600-960 mg), vi) salt (<5 gm/day) (24). Subjects will be specifically advised to limit extra salt, caffeine and sugar intake. Special weighted scoops will be provided to each participant in order to estimate the amount of specific food intake at certain meal (e.g. rice, pasta, etc.). Then, all the participants will be instructed to fill in an online application of their type and amount of food intake on a daily basis. The dietician will assess the compliance to healthy diet through the online application and give advice where necessary. A motivational phone consultation for each participant in the intervention group will be carried out by the principal and co-principal investigators once every two weeks throughout the study period. It will basically include motivating the participants to comply with the dietary advice given and find out any challenges that they may have encountered which may impede their adherence. Both groups (intervention and control group) will receive similar advice regarding physical exercise at baseline. Intervention 2: Control group: Subjects in the control group will not receive dietary advice at baseline. However, dietary counseling for each subject in the control group will be provided at the end of the study by the same dietician. Notably, both groups (intervention and control group) will receive similar advice regarding physical exercise at baseline. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD from the study titled: Effects of healthy diet in reducing symptoms of premenstrual syndrome and improving quality of life among Omani Adolescents; a randomized controlled open label trial When: Starting 6 months after publication To whom: Academic institutions only Conditions: For Systematic Reviews and Metaanalysi Where to obtain: Dr.Zaleikha Al Belushi : albelushi11@hotmail.com How to obtain: Authorized researchers from academic institutions only can get in touch with Dr Zaleikha Al belushi at her above email address. Comments:
public Zalekha Issa Ali Al Belushi
Khadraween road
Shinas Oman 324 +968 26 724056 albelushi11@hotmail.com Ministry of health scientific Ethics committee of center of studies and research in Ministry of health
Khadraween road
Shinas Oman 324 +968 26 724056 albelushi11@hotmail.com Ministry of health,Oman Oman Adolescents who are at grade 10 or 11, aged 16 years to 19 years old, and have regular menstrual cycles will be included in the study 16 years 19 years Female known to have psychiatric disorders (such as depression, generalized anxiety disorder, post-traumatic stress disorder, psychotic disorders), diabetes, thyroid disease, oral contraceptive use, herbal remedy use for PMS symptoms, and those who have had dietary advice before for PMS symptoms. N94.3 premenstrual syndrome Treatment - Other Other Intervention group :Subjects in the intervention group will receive an individual face-to-face dietary consultation by a well-experienced dietician. She will educate the participants about the importance of healthy diet, evaluate the baseline dietary habits of each participant and give advice on how to modify them. The healthy diet advice is derived from the food-based dietary guidelines (FBDG) that were proposed for Omani adolescents (24). FBDG for Omani adolescents includes a daily intake of the following: i) carbohydrates (330-450 g), ii) protein (48-60 g), iii) fibers (19-48 g), iv) energy (2400 lcal), v) calcium (600-960 mg), vi) salt (<5 gm/day) (24). Subjects will be specifically advised to limit extra salt, caffeine and sugar intake. Special weighted scoops will be provided to each participant in order to estimate the amount of specific food intake at certain meal (e.g. rice, pasta, etc.). Then, all the participants will be instructed to fill in an online application of their type and amount of food intake on a daily basis. The dietician will assess the compliance to healthy diet through the online application and give advice where necessary. A motivational phone consultation for each participant in the intervention group will be carried out by the principal and co-principal investigators once every two weeks throughout the study period. It will basically include motivating the participants to comply with the dietary advice given and find out any challenges that they may have encountered which may impede their adherence. Both groups (intervention and control group) will receive similar advice regarding physical exercise at baseline. Control group: Subjects in the control group will not receive dietary advice at baseline. However, dietary counseling for each subject in the control group will be provided at the end of the study by the same dietician. Notably, both groups (intervention and control group) will receive similar advice regarding physical exercise at baseline. The improvements in the severity of premenstrual symptoms. Timepoint: At baseline and 2 months after intervention. Method of measurement: Daily Record of Severity of Problem (Arabic version). Improvements in quality of life. Timepoint: at baseline and at the end of 2 months of starting the intervention. Method of measurement: The medical outcome study short form-36 (SF-36) and Perceived stress scale PSS. application for fund was done and still awaiting approval Approved 2020-11-23 Ethics Committee of Ministry of Health P.O.Box:393, Post code:100, Muscat, Oman Muscta Muscat Oman