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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.

Protocol summary

Study aim
،to determine the 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 randomised controlled trial.
Design
In this single-blind randomized, controlled trial with two parallel arms, 60 elderly eligible women will be randomly assigned into two groups using block randomization with block sizes of 4 and 6, and the ratio of 1: 1, receiving 1) family-center educational intervention, 2) control ________________________________________
Settings and conduct
Eligible women after necessary assessments and receiving written informed consent will be randomized into one of the two groups of education or control. Intervention group will receive education for 10 weeks. Statistical analyst will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women aged 60 years and older, Having a health record in Tabriz's elderly friendly health centers, having reading and writing skills, the ability to do routines independently. Exclusion criteria: Follow a specific diet, prohibition of any sports activity, having neurological disorders and known psychological diseases based on patient's remarks and health records, having acute cardiovascular events based on patient's remarks and health records, having uncontrollable chronic diseases, restrictive musculoskeletal disorders
Intervention groups
The group receiving family-centered education and the group not receiving education
Main outcome variables
Serum levels of glucose (fasting blood glucose and insulin resistance), serum levels of lipid profile (triglyceride, total cholesterol, HDL, LDL), serum levels of calcium and 25-hydroxyvitamin D

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131009014957N5
Registration date: 2018-10-09, 1397/07/17
Registration timing: prospective

Last update: 2018-10-09, 1397/07/17
Update count: 0
Registration date
2018-10-09, 1397/07/17
Registrant information
Name
Azizeh Farshbaf-khalili
Name of organization / entity
Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1333 9151
Email address
farshbafa@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-12, 1397/07/20
Expected recruitment end date
2019-08-11, 1398/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
Effect of educational intervention on some of the serum hyperglycemia indices, lipid profile, calcium and vitamin D in elderly women.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
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. ________________________________________
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research Vice-chancellor of Tabriz University of Medical Sciences., End of Gholgasht Ave., Tabriz., Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-08-06, 1397/05/15
Ethics committee reference number
IR.TBZMED.REC.1397.396

Health conditions studied

1

Description of health condition studied
Elderly women aged 60 years or older who are able to do routines independently.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
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.

2

Description
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

3

Description
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

Secondary outcomes

1

Description
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).

2

Description
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.

Intervention groups

1

Description
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.
Category
Lifestyle

2

Description
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.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Elderly friendly Health Centers
Full name of responsible person
Dr. Mitra Yeghaneh
Street address
Nesfrah Square., Tabriz health center
City
Tabriz
Province
East Azarbaijan
Postal code
51837
Phone
+98 41 3444 0057
Email
yeghanehm@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Abolghasem Jouyban
Street address
No. 2 Central building of the university, Golgasht street, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Azizeh Farshbaf-Khalili
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht Street, Imam Reza Hospital, Ground Floor, Research Center of Physical Medicine and Rehabilitation
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 1928
Email
farshbafa@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Azizeh Farshbaf-Khalili
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht Street, Imam Reza Hospital, Ground Floor, Research Center of Physical Medicine and Rehabilitation
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 1928
Email
farshbafa@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Azizeh Farshbaf-Khalili
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht Street, Imam Reza Hospital, Ground Floor, Research Center of Physical Medicine and Rehabilitation
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 1928
Email
farshbafa@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Requested data will be provided to researchers for statistical analysis of the submitted proposal (meta-analysis).
When the data will become available and for how long
starting immediately after publication
To whom data/document is available
Data will be available to researchers as well as to journals
Under which criteria data/document could be used
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.
From where data/document is obtainable
Refer to the email address (farshbafa@tbzmed.ac.ir)
What processes are involved for a request to access data/document
The requests will be sent by email and data will be available within a week
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