Designing and assessing the effectiveness of a community-based social marketing campaign on the social support, self-efficacy and physical activity of the elderly
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General information
2024-06-09, 1403/03/20
2024-11-10, 1403/08/20
2024-0611-0910 00:00:00
2024-07-10, 1403/04/20
2024-12-10, 1403/09/20
2024-0712-10 00:00:00
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Sampling has not been done so far due to lack of funding. I have a request to change the sampling date from July to November this year for one month.
Sampling has not been done so far due to lack of funding. I have a request to change the sampling date from July to November this year for one month.
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نمونه گیری به دلیل عدم تامین بودجه تا کنون صورت نگرفته است. درخواست تغییر تاریخ نمونه گیری از تیر به آبان ماه سال جاری به مدت یکماه را دارم.
نمونه گیری به دلیل عدم تامین بودجه تا کنون صورت نگرفته است. درخواست تغییر تاریخ نمونه گیری از تیر به آبان ماه سال جاری به مدت یکماه را دارم.
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyyed Roghayeh Safavi
Full name of responsible person - Persian: سیده رقیه صفوی
Position - English: دانشجوی دکتری تخصصی
Position - Persian: PhD
Latest degree: master
Area of specialty/work: 14
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Enghelab St., Qods St., Porsina St., Faculty of Health
Street address - Persian: خیابان انقلاب، خیابان قدس، خیابان پورسینا، دانشکده بهداشت
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1417613151
Phone: +98 21 4293 3261
Mobile: +98 911 456 0649
Fax: +98 21 4293 3261
Email: Roghayehsafavi@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyyed Roghayeh Safavi
Full name of responsible person - Persian: سیده رقیه صفوی
Position - English: PhD
Position - Persian: دانشجوی دکتری تخصصی
Latest degree: master
Area of specialty/work: 14
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Enghelab St., Qods St., Porsina St., Faculty of Health
Street address - Persian: خیابان انقلاب، خیابان قدس، خیابان پورسینا، دانشکده بهداشت
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1417613151
Phone: +98 21 4293 3261
Mobile: +98 911 456 0649
Fax: +98 21 4293 3261
Email: Roghayehsafavi@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Seyyed Roghayeh Safavi Full name of responsible person - Persian: سیده رقیه صفوی Position - English: دانشجوی دکتری تخصصیPhD Position - Persian: PhDدانشجوی دکتری تخصصی Latest degree: master Area of specialty/work: 14 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Enghelab St., Qods St., Porsina St., Faculty of Health Street address - Persian: خیابان انقلاب، خیابان قدس، خیابان پورسینا، دانشکده بهداشت City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1417613151 Phone: +98 21 4293 3261 Mobile: +98 911 456 0649 Fax: +98 21 4293 3261 Email: Roghayehsafavi@yahoo.com Web page address:
Protocol summary
Study aim
The purpose of this research is to promote health-related behaviors, improve social support, self-efficacy and physical activity of the elderly.
Design
Random allocation of centers to the intervention and control groups using the balanced block randomization method - 500 people - community-based survey intervention
Settings and conduct
Samples: 65 to 75-year-olds in Rasht city - design and implementation of a community-based survey intervention with the participation of the elderly - the control group only receives routine geriatric care - blinding is not possible.
Participants/Inclusion and exclusion criteria
Elderly people of Rasht city, 65 to 75 years old/- Having the desire and consent to participate in the research
Inclusion criteria:
-Age 65 to 75 years old (based on information registered in Sib system)
- Absence of cognitive problems such as dementia and Alzheimer's (based on information recorded in the Sib system)
- Absence of diagnosed severe osteoporosis (based on the information recorded in the apple system and asking the person)
- Having minimum reading and writing literacy to complete the questionnaire
Exit criteria:
- Unwillingness to continue participating in the study
- Elderly people with mobility problems related to wheelchairs
-Migration
- death
Intervention groups
Forming a community-oriented campaign committee, holding an educational-advisory meeting, campaign implementation, interpersonal intervention in the direction of social support, intervention in the direction of improving the self-efficacy of holding the festival, free training courses, discount plans, etc. The control group will only take care of will receive the aging routine.
Main outcome variables
Social support, Self-efficacy, Physical activity
General information
Reason for update
Sampling has not been done so far due to lack of funding. I have a request to change the sampling date from July to November this year for one month.
Acronym
SMC
IRCT registration information
IRCT registration number:IRCT20240429061582N1
Registration date:2024-05-22, 1403/03/02
Registration timing:prospective
Last update:2024-07-15, 1403/04/25
Update count:1
Registration date
2024-05-22, 1403/03/02
Registrant information
Name
Roghayeh Safavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3332 5075
Email address
roghayehsafavi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-10, 1403/08/20
Expected recruitment end date
2024-12-10, 1403/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing and assessing the effectiveness of a community-based social marketing campaign on the social support, self-efficacy and physical activity of the elderly
Public title
Effects of community-based social marketing campaign on social support, self-efficacy and physical activity of the elderly
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having the desire and consent to participate in the research
Age 65 to 75 years (based on the information registered in the Sib system)
Absence of cognitive problems such as dementia and Alzheimer's (based on the information registered in the Sib system)
Absence of diagnosed severe osteoporosis (based on the information recorded in the Sib system and asking the individual)
having minimum reading and writing literacy to complete the questionnaire
Exclusion criteria:
Unwillingness to continue participating in the study
Elderly people with mobility problems related to wheelchairs
Migration
death
Age
From 65 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
500
More than 1 sample in each individual
Number of samples in each individual:
1
An elderly person 65 to 75 years old living in Rasht city
Randomization (investigator's opinion)
Randomized
Randomization description
Using the block randomization table, centers are randomly assigned to intervention and control. Out of 16 centers, 8 will be intervention centers and 8 will be control centers. The number of participants in the group will be the same. Centers A will be the intervention and B will be the control.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A community-based campaign
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Working group of Ethics Committee in Research Faculty of Health and Paramedicine-Tehran University
Street address
Enghelab St., Quds St., Porsina St., Faculty of Health
City
Tehran
Province
Guilan
Postal code
1417613151
Approval date
2024-04-28, 1403/02/09
Ethics committee reference number
IR.TUMS.SPH.REC.1403.017
Health conditions studied
1
Description of health condition studied
Inactivity in the elderly
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Social support
Timepoint
3 Month
Method of measurement
Questionnaire of social support for physical activity by Sallis et al.
2
Description
Self-Efficacy
Timepoint
3 months
Method of measurement
Physical Activity Self-Efficacy Questionnaire for the Elderly, Shamsalinia et al.
Secondary outcomes
1
Description
Physical activity
Timepoint
6 months
Method of measurement
Short Form Physical Activity Questionnaire, Lee et al
Intervention groups
1
Description
Intervention group: 65 to 75-year-olds are residents of Rasht city, and based on the decisions of the campaign committee, interventions such as educational sessions, festivals, public walks, group discussion sessions, etc. are carried out for them. The elderly group in this committee includes 10 people are neighborhood health liaisons and elderly health ambassadors, each of whom will be responsible for 25 elderly people. The survey will be carried out in a period of 3 months with the method (3 messages, 3 times, 3 methods per month). The contents will be prepared in printed and electronic form from the source of physical activity guide in the old age of the Ministry of Health and Medical Education.
Category
Behavior
2
Description
Control group: will only receive the routine elderly care of the Ministry of Health.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive urban health service centers of Rasht
Full name of responsible person
Seyyed Mahmoud Rizvani
Street address
Rasht. Farhang Square, Azadegan Gilan Province, Health Deputy
City
Rasht
Province
Guilan
Postal code
41886-14975
Phone
+98 13 3334 6593
Fax
+98 13 3332 2057
Email
Roghayehsafavi@yahoo.com
Web page address
https://health.gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Roya Sadeghi
Street address
Enghelab St., Qods St., Porsina St., Faculty of Health
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 4293 3333
Fax
+98 21 4293 3261
Email
sph@tums.ac.ir
Web page address
Http://tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Seyyed Roghayeh Safavi
Position
PhD
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Enghelab St., Qods St., Porsina St., Faculty of Health
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 4293 3261
Fax
+98 21 4293 3261
Email
Roghayehsafavi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Roya Sadeghi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Enghelab St., Qods St., Porsina St., Faculty of Health
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 4293 3333
Fax
+98 21 4293 3261
Email
Sadeghir@tums.ac.ir
Web page address
Http://tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ensieh Jamshidi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Enghelab St., Qods St., Porsina St., Faculty of Health
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 4293 3333
Fax
+98 21 4293 3261
Email
ensieyh_jamshidi@yahoo.com
Web page address
Http://tums.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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The entire data can potentially be shared after de-identifying people or, for example, only part of the data, such as information related to the main outcome or the like, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data/document will be available for researchers working in academic and scientific institutions and policymakers in the field of aging.
Under which criteria data/document could be used
It will be possible for the planners in the field of aging of the Ministry of Health to use the data with the consent of the researcher.
From where data/document is obtainable
Seyyed Roghayeh Safavi. PhD Candidate of Tehran University of Medical Sciences. Email: Roghayehsafavi@yahoo.com. Contact number: 09114560649. Address: Rasht, Farhang Square, Azadegan Street. Gilan Province Health Deputy
What processes are involved for a request to access data/document
Documents and files will be sent by e-mail within 5 working days.