Determining the effect of group walking program on social anxiety and risk of eating disorders in elderly women
Design
Clinical trials with control group, cluster random sampling for health care centers and regular samples for selecting 50 samples in this study and divided into two groups. .
Settings and conduct
This is a clinical trial in which two groups of test and control participate.
The statistical population includes all young elderly (60 to 74 years old) who will be selected from health centers in Sari and the impact of walking on the social anxiety of the organs and the risk of eating disorders are reviewed.
Participants/Inclusion and exclusion criteria
Entry criteria :
1- Age 74-60 years
2- Interesting and satisfying to participate in the research (obtaining informed consent).
3. Having reading and writing skills
4. Earn score 8 and above the short-term test
5- Earning an independent score from the daily activities of life questionnaire
6. Not having known chronic diseases according to health records
7. Not having a history of acute accidents and events leading to a mental and physical problem within the past month
8. Earn score 20 and above the risk of eating disorder
9) Earn score 15 and above of Social physique Anxiety Scale
10. No history of regular exercise over the past six months
11. No drug use
Intervention groups
Group intervention in group walking sessions, for 8 weeks, weekly 3 sessions, each session is 30 minutes, but there is no intervention in the control group.
Main outcome variables
walking
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180505039538N1
Registration date:2018-12-05, 1397/09/14
Registration timing:retrospective
Last update:2018-12-05, 1397/09/14
Update count:0
Registration date
2018-12-05, 1397/09/14
Registrant information
Name
Sharare Khalili
Name of organization / entity
The university of babol
Country
Iran (Islamic Republic of)
Phone
+98 11 3327 2156
Email address
sh.khalili@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-11-17, 1395/08/27
Expected recruitment end date
2017-11-18, 1396/08/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the effect of group base walking program on social physical anxiety and eating disorders risk in elderly woman
Public title
Effect of group walking program on social physical anxiety and eating disorders
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age 60 to 74 years
Interests and satisfaction to participate in the research
Have reading and writing skills
Earn score 8 and above the short cognitive test
Earn a score independent of the daily life activity questionnaire
Earn a score independent of the daily life activity questionnaire...
Earn score 15 and above the Social Anxiety Scale
Exclusion criteria:
Cases of known chronic diseases according to health records
Having a history of acute accidents and events has led to a physical and mental problem during the past month
A record of regular sports letters over the past six months
Use special medication
Age
From 60 years old to 74 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling will be multistage cluster method, so that each one of the 12 health-care centers located in Sari will be considered as a cluster. Then will be taken from clusters, six clusters are randomly selected. The cluster, according to the sample size, is elderly women, based on the list of names. They will be randomly divided into two groups of test and control choosing a number from 1 to 60 randomly, in a such way that odds number in the test group and even number are in the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
7
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ramsar University of Nursing and Midwifery
Street address
University of Nursing and Midwifery-Ramsar
City
Ramsar
Province
Mazandaran
Postal code
4691714141
Approval date
2017-11-18, 1396/08/27
Ethics committee reference number
MUBABOL.HRI.REC.1396.123
Health conditions studied
1
Description of health condition studied
Social physique anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Group walking
Timepoint
Measurement was performed before and immediately after the intervention.
Method of measurement
Daily Life Activity Questionnaire
2
Description
Eating disorder
Timepoint
Measurement was performed before and immediately after the intervention.
Method of measurement
Risk screening test for eating disorder
3
Description
Social physique anxiety
Timepoint
Measurement was performed before and immediately after the intervention.
Method of measurement
Social physique Anxiety Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group samples will be invited with written invitations, phone calls and SMS to remind attending the walking sessions. The type of intervention is a group walk that will be conducted by the researcher in the Sari Melal Park for eight weeks, three days a week, at a specific time of the day. The duration of each hike session will be 30 minutes. In the final session after the intervention, as a post-test, both social anxiety and eating disorder questionnaires are repeated with face-to-face interviews.
Category
Prevention
2
Description
Control group: The control group, such as the intervention group will fill the questionnaires but will not do any physical activity.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers in Sari
Full name of responsible person
Sharareh Khalili-Hengame Karimi
Street address
Taleghani-EmamReza blv
City
Sari
Province
Mazandaran
Postal code
4818955830
Phone
+98 11 3327 2165
Email
sh.khalili@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sharareh Khalili
Street address
Taleghani-EmamReza blv
City
Sari
Province
Mazandaran
Postal code
4818955830
Phone
+98 11 3327 2165
Email
sh.khalili@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Sharareh khalili-Hengameh karimi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Taleghani-EmamReza blv-Sari
City
Sari
Province
Mazandaran
Postal code
4818955830
Phone
+98 11 3327 2165
Email
sh.khalalili@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sharareh Khalili-Hengameh Karimi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Taleghani-EmamReza blv
City
Sari
Province
Mazandaran
Postal code
4818955830
Phone
+98 11 3327 2165
Email
sh.khalili@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sharare khalili_ Hengame karimi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Taleghani-emamReza blv-Sari
City
Sari
Province
Mazandaran
Postal code
4818955830
Phone
+98 11 3327 2165
Email
sh.khalili@mubabol.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
A portion of the recorded data will be available from statistical samples that help to understand the research topic and its effects
When the data will become available and for how long
Since 2018
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
The use of documentation in order to develop research is permitted
From where data/document is obtainable
Ramsar University of Nursing and Midwifery
What processes are involved for a request to access data/document