Protocol summary

Study aim
Determining the effect of educational intervention based on self-efficacy theory on improving nutritional status of elderly
Design
Quasi-experimental study with control group, with parallel groups and non-random allocation
Settings and conduct
Educational intervention will be implemented with an emphasis on self-efficacy theory,for a maximum of 3 month t on elderly people who referred to Mashhad health centers.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: having at least 60 years of age, Having informed consent Non Inclusion Criteria: Having cognitive disorders and psychiatric records
Intervention groups
Intervention group:Educational intervention based on self-efficacy theory Control group: There will be no intervention on the control group
Main outcome variables
Nutritional status of elderly

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160619028529N9
Registration date: 2019-01-05, 1397/10/15
Registration timing: registered_while_recruiting

Last update: 2019-01-05, 1397/10/15
Update count: 0
Registration date
2019-01-05, 1397/10/15
Registrant information
Name
Hadi Tehrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3853 8530
Email address
tehranih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-05, 1397/08/14
Expected recruitment end date
2019-06-05, 1398/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Educational Intervention Based on Self-Efficacy Theory on Nutritional Status in the Elderly People Referred to health centers of Mashhad
Public title
The impact of education on nutritional status of the elderly
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 60 years old Having informed consent
Exclusion criteria:
Having cognitive disorders and psychiatric records
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vice chancellor for research, Qoreishi Building, Daneshgah 18, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2018-09-08, 1397/06/17
Ethics committee reference number
IR.MUMS.REC.1397.154

Health conditions studied

1

Description of health condition studied
Nutrition status
ICD-10 code
E63
ICD-10 code description
Other nutritional deficiencies

Primary outcomes

1

Description
Nutrition status
Timepoint
Before the intervention, immediately and, three months after the intervention
Method of measurement
Food Frequency Questionnaire, Behavioral View Checklis

Secondary outcomes

1

Description
Self-Efficacy
Timepoint
Before intervention, immediately and,three months after the intervention
Method of measurement
Researcher made questionnaire

Intervention groups

1

Description
Intervention group: Educational intervention will be implemented with an emphasis on self-efficacy theory,for a maximum of 3 months on elderly people who referred to Mashhad health centers.Educational intervention will take place in 6 one-hour training sessions with emphasis on self-efficacy teaching materials. The training sessions will be held in a group discussion.In this study, considering the characteristics of the target group that are elderly and the objectives of the curriculum are various oral, written and combination methods and methods used by the media for training such as lectures with questions and answers, providing and presenting suggestions, group discussion, practical presentation, role play and the provision of educational media such as booklets, posters and educational CDs are provided in the form of a training package for independent study for learners.
Category
Lifestyle

2

Description
Control group: Only the routine intervention will be received.The routine interventions in this area include nutritional counseling
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad health centers
Full name of responsible person
Amir Rasoulifar
Street address
School of Public Health,Sanabad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3841 5001
Email
Health@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Research Deputy, Qoreishi Building, Daneshgah 18, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3841 1538
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hadi Tehrani
Position
Assisstance Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education and Health Promotion. School of Public Health, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3189 2203
Email
tehranih@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hadi Tehrani
Position
Assisstance Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education and Health Promotion. School of Public Health, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3189 2203
Email
tehranih@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hadi Tehrani
Position
Assisstance Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education and Health Promotion. School of Public Health, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 5189 2203
Email
tehranih@mums.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Potential data is sharable after distinguishing people
When the data will become available and for how long
Start the access period one month after the publication of result
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Data is sent through an official request and by email
From where data/document is obtainable
Hadi Tehrani: tehranih@mums.ac.ir
What processes are involved for a request to access data/document
Data is sent through an official request and by email
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