People more than 60 years old who referred to nutrition clinic of Shahid Motahari hospital and willing to participate in the study and in the initial sampling the score were lower than 17 will enter in the study.
People who miss more than one session of training sessions or suffering from cardiovascular and respiratory and another debilitating diseases which make trouble walking and attending in classes alone, are excluded from the study
Intervention groups
The intervention group will receive four training sessions and to the control group will be given the usual recommendations include diet and required nutrition plan
Main outcome variables
Awareness of severity of malnutrition in the study population
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200119046186N1
Registration date:2020-03-10, 1398/12/20
Registration timing:registered_while_recruiting
Last update:2020-03-10, 1398/12/20
Update count:0
Registration date
2020-03-10, 1398/12/20
Registrant information
Name
Majid Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 9821
Email address
rahimi@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-03-15, 1398/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Educational Intervention based on Self-care model on malnutrition in older people
Public title
Effect of Educational Intervention on malnutrition in older people
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
people older than 60 years old
Willingness to participate in the study
Exclusion criteria:
Suffering from diseases which Which make them unable to attend classes
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomizing using random number table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
The intervention group received four training sessions and the control group is given regular recommendations including the diet and diet plan needed
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
No. 47 Hajian Lane Simin Ave.
City
Isfahan
Province
Isfehan
Postal code
81769-35747
Approval date
2019-12-25, 1398/10/04
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.592
Health conditions studied
1
Description of health condition studied
Malnutrition
ICD-10 code
E46
ICD-10 code description
Unspecified protein-calorie malnutrition
Primary outcomes
1
Description
Malnutrition Score in Mini Nutrition Assessment Questionnaire
Timepoint
Before and two weeks after the 4th educational session
Method of measurement
Mini Nutrition Assessment Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to the usual recommendations in the nutrition clinic including obtaining a nutrition history and prescribing a proper diet ,there are four training sessions based on the self-care model about the following topics: 1- Impact of lifestyle on health and its components, 2- Healthy nutrition and malnutrition and how to cook, 3- Depression and its effect on nutrition and 4- Drug usage and its effect on nutrition
Category
Lifestyle
2
Description
Control group: The usual recommendations including obtaining a nutrition history and prescribing a proper diet are made.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shdhid Motahary Hospital at Isfahan
Full name of responsible person
Majid Rahimi
Street address
Next to Zobeahan Highway
City
Foolad Shahr
Province
Isfehan
Postal code
84918-13113
Phone
+98 31 5262 4141
Fax
+98 31 5262 3142
Email
mail@motaharyhospital.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooye Javanmard
Street address
Hezarjerib Ave., Isfahan University Of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Majid Rahimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
No 47,. Hajian Lane., Simin Ave.
City
Isfahan
Province
Isfehan
Postal code
81769-35747
Phone
+98 31 3776 9821
Email
rahimi@hlth.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Majid Rahimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
No. 47, Hajian Lane, Simion Ave.
City
Isfahan
Province
Isfehan
Postal code
81769-35747
Phone
+98 31 3776 9821
Email
rahimi@hlth.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Majid Rahimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
No. 47, Hajian Lane, Simin Ave.
City
Isfahan
Province
Isfehan
Postal code
81769-35747
Phone
+98 31 3776 9821
Email
rahimi@hlth.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In the results section according to the variables table, things like age, gender, body mass will be shared
When the data will become available and for how long
Documentation will be published shortly after the results are completed and the paper is prepared
To whom data/document is available
Data access will have no modifications except personal information of study participants
Under which criteria data/document could be used
In cases where further research is needed
From where data/document is obtainable
Refer to the project manager and it's possible to request data access via email: majidnh79@gmail.com
What processes are involved for a request to access data/document
It must be requested via email with valid documentation provided about the research related to the subject of the present research, Submit written commitment to use the documentation with citing to original reference and
Submit results of next research to project manager