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IRCT20131009014957N5 IRCT 2018-10-09 Tabriz University of Medical Sciences Effect of educational intervention on some of the serum hyperglycemia indices, lipid profile, calcium and vitamin D in elderly women. Effect of educational intervention according family-centered empowerment model (FCEM) on some of the serum hyperglycemia indices, lipid profile, calcium and vitamin D in elderly women : a randomized controlled trial. 2018-10-12 anticipated 60 Complete https://irct.ir/trial/34189 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Women aged 60 years or older will be randomly assigned into two groups of recipients of training or control using random blocking method and blocks 4 and 6 through Random Allocation Software (RAS) with a 1: 1 assignment ratio by the person not involved in the research. To conceal the allocation, the name of group will be placed inside a consecutively numbered sealed opaque envelopes. Preparation of envelopes and sequence generation will be done by a person not involved in participant recruitment or data collection. ________________________________________. N/A Elderly women aged 60 years or older who are able to do routines independently.. Intervention 1: Intervention group: Recipient of educational intervention based on family-centered empowerment model in 10 sessions of 45 minutes for 10 weeks. For step-by-step implementation and application of the family-centered empowerment model, four executive stages will be designed for them that are consistent and coherent and are as follows: Perceived threat, problem solving, educational participation and evaluation. Intervention 2: Control group: During the study, this group will not receive any education, but after completion of the educational program, follow up and completion of the questionnaires, the educational program will be provided in the form of a meeting with the booklet. Yes - There is a plan to make this available What will be shared: Requested data will be provided to researchers for statistical analysis of the submitted proposal (meta-analysis). When: starting immediately after publication To whom: Data will be available to researchers as well as to journals Conditions: The data will be available to researchers upon request and submission of a proposal to perform meta-analysis using IPD data after being unidentified. Also, in exceptional cases, data will be made available to journals for checking. Where to obtain: Refer to the email address (farshbafa@tbzmed.ac.ir) How to obtain: The requests will be sent by email and data will be available within a week Comments:
public Dr. Azizeh Farshbaf-Khalili
Golgasht Street, Imam Reza Hospital, Ground Floor, Research Center of Physical Medicine and Rehabilitation
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3336 1928 farshbafa@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr. Azizeh Farshbaf-Khalili
Golgasht Street, Imam Reza Hospital, Ground Floor, Research Center of Physical Medicine and Rehabilitation
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3336 1928 farshbafa@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Women aged 60 years or older having a health record in the Tabriz Elderly Friendship Centers having read and write literacy ability to do routines independently having a family member to attend educational sessions 60 years no limit Female Follow a specific diet (eg vegetarians) Prohibition of any sports activity as directed by the physician Having neurological disorders (stroke - Parkinson's disease and paralysis) and known psychological diseases based on patient's remarks and health records Having acute cardiovascular events (acute myocardial infarction - acute heart failure and uncontrolled hypertension) based on patient's remarks and health records Having uncontrollable chronic diseases (such as advanced diabetes and malignant diseases) Restrictive musculoskeletal disorders Lifestyle N/A Intervention group: Recipient of educational intervention based on family-centered empowerment model in 10 sessions of 45 minutes for 10 weeks. For step-by-step implementation and application of the family-centered empowerment model, four executive stages will be designed for them that are consistent and coherent and are as follows: Perceived threat, problem solving, educational participation and evaluation. Control group: During the study, this group will not receive any education, but after completion of the educational program, follow up and completion of the questionnaires, the educational program will be provided in the form of a meeting with the booklet. The mean serum level of hyperglycemia indices (fasting blood glucose and insulin resistance) in the studied groups. Timepoint: At baseline, 8 weeks and 6 months after the intervention. Method of measurement: FBS and fasting insulin will be measured by spectrophotometry with Alcyon 300 model using the Pars Test Kit, and ELISA method by ELISA kit, respectively. The mean serum lipid profile (triglyceride, total cholesterol, HDL, LDL) in the studied groups. Timepoint: At baseline, 8 weeks and 6 months after the intervention. Method of measurement: by spectrophotometry with Alcyon 300 model using the Pars Test Kit, and ELISA method by ELISA. Mean serum levels of calcium and 25-hydroxy vitamin D in the studied groups. Timepoint: At baseline, 8 weeks and 6 months after the intervention. Method of measurement: Calcium by spectrophotometer with Alcyon 300 and using Pars Test Kit; 25-hydroxy vitamin D by Elisa method using ELISA kit. Mean scores of anthropometric characteristics (weight, BMI, waist circumference, waist to hip ratio) in the studied groups. Timepoint: At baseline, 4 weeks, 8 weeks and 6 months after the intervention. Method of measurement: The weight is measured by the Seca scale with a precision of 0.1 kg, height by stadiometer, waist and hip circumference with tape measure, and BMI by dividing the weight (kg) to squared height (meter). The mean systolic and diastolic blood pressure score in the studied groups. Timepoint: At baseline, 4 weeks, 8 weeks and 6 months after the intervention. Method of measurement: The blood pressure will be checked by the German mercury barometer. Tabriz University of Medical Sciences Approved 2018-08-06 Ethics committee of Tabriz University of Medical Sciences Research Vice-chancellor of Tabriz University of Medical Sciences., End of Gholgasht Ave., Tabriz., Iran. Tabriz East Azarbaijan Iran (Islamic Republic of)