Determining the effect of physical activity training based on health belief model on quality of life during menopause in women 40 to 50 years old referring to comprehensive health service centers in Isfahan in 1399-1400
Design
Educational intervention with a control group, one blind,, on 80
Settings and conduct
in each health center, aquestionnaires are completed from ten eligible people, then randomly, four centers as the intervention group and the other four centers as the control group. in Intervention group, intervention is online training based on the health belief model through WhatsApp about the premenopausal period, the need to do physical activity in this period and the correct way to do physical activity. Two months after the training again Questionnaires are completed. The data analyzer does not know about assigning individuals to the intervention and control group and the study is a blind.
Participants/Inclusion and exclusion criteria
inclusion criteria:
- Women 40 to 50 years old who have entered the menopausal period (who report signs of changes in menstrual cycles
Exclusion criteria:
- premature menopause
Intervention groups
The components of educational intervention are divided into two parts: teaching concepts based on model structures and teaching sports exercises. Concept training is sent to participants in the form of packages of videos, podcasts, posters and text messages every two weeks in the WhatsApp group. Then they have two weeks to think, discuss and provide feedback on the submitted content. Exercise training: Aerobics training, endurance and stretching exercises at home online by an exercise instructor, 3 sessions per week, each session for 40 minutes, for 2 months.The control group includes people who do not receive any educational intervention
Main outcome variables
The scores of health belief model constructs;
physical activity score
quality of life score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210602051478N1
Registration date:2022-05-17, 1401/02/27
Registration timing:retrospective
Last update:2022-05-17, 1401/02/27
Update count:0
Registration date
2022-05-17, 1401/02/27
Registrant information
Name
Mahboobeh Amini. Neisiany
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3448 9373
Email address
m.amini@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of physical activity training based on health belief model on quality of life during menopause in women 40 to 50 years
Public title
The effect of physical activity training on quality of life in women aged 40 to 50 years
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women in their 40s and 50s who have entered menopause (who report signs of changes in menstrual cycles)
Housewives with active records in health centers
At the doctor's discretion, they are not prohibited from doing aerobic exercise and endurance and stretching exercises
Lack of regular regular physical activity in the last 3 months (150 minutes per week)
No
No
Having a phone with the possibility of installing WhatsApp software and the ability to work with it
Exclusion criteria:
premature menopause
use of estrogen in the last three months
Age
From 40 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the person in charge of data analysis does not know which codes belong to the intervention group and which codes belong to the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, Building No. 4, Vice Chancellor for Research and Technology
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2021-05-26, 1400/03/05
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.075
Health conditions studied
1
Description of health condition studied
perimenopause period
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Physical activity score
Timepoint
Before the intervention and two months after the intervention
Method of measurement
questionnaire IPAQ
2
Description
Quality of Life
Timepoint
Before the intervention and two months after the intervention
Method of measurement
questionnaire MENQOL
Secondary outcomes
1
Description
Perceived sensitivity score to the effects of sedentary lifestyle
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Health Belief Model of Physical Activity Questionnaire
2
Description
Perceived severity score to sedentary effects
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Health Belief Model of Physical Activity Questionnaire
3
Description
Score the perceived benefits of physical activity
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Health Belief Model of Physical Activity Questionnaire
4
Description
Awareness score
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Health Belief Model of Physical Activity Questionnaire
5
Description
Score perceived barriers to physical activity
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Health Belief Model of Physical Activity Questionnaire
6
Description
Self-efficacy score
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Health Belief Model of Physical Activity Questionnaire
Intervention groups
1
Description
Intervention group:Educational intervention is divided into two parts: teaching concepts based on model structures and teaching sport exercises. The concepts are sent to participants in the form of packages of videos, podcasts, posters and text messages every two weeks in the WhatsApp group. They have two weeks to think and discuss and provide feedback on the submitted content. Individuals are asked to send their feedback in the form of an audio or text message to the group as desired. If people do not respond in the form of a message They are privately questioned. Exercise training: Aerobics training, endurance and stretching exercises at home online by the exercise instructor, 3 sessions per week, each session for 40 minutes, for 2 months. Video sessions will be provided to participants. In addition, the poster And the gif of exercises will be presented in the group. At the end, the educational content will be provided to the participants in the form of DVDs and booklets.
Category
Lifestyle
2
Description
Control group: no intervention is performed on them.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Health Deputy
Full name of responsible person
Dr. Kamal Heydari
Street address
Ibn Sina St., next to Amin Hospital, Isfahan Deputy Minister of Health
City
Esfahan
Province
Isfehan
Postal code
8148653374
Phone
+98 31 3447 6060
Email
Health@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoi Javanmard
Street address
Hezar Jarib St., Isfahan University of Medical Sciences, Building No. 4, Vice Chancellor for Research and Technology
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 7898
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
Mahboobeh Amini Neisiany
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Laleh St., Golrokh Alley, Islamic Alley, No. 20
City
Esfahan
Province
Isfehan
Postal code
8198335631
Phone
+98 31 3448 9373
Email
klmnam789@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Asieh pirzadeh
Position
University faculty
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education, Faculty of Health, Isfahan University of Medical Sciences, Hezar Jarib St.
City
Esfahan
Province
Isfehan
Postal code
8174673661
Phone
+98 31 3792 3340
Email
as_pirzadeh@hlth.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahboobeh Amini Neisiany
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Laleh St., Golrokh Alley, Islamic Alley, No. 20
City
Esfahan
Province
Isfehan
Postal code
8198835631
Phone
+98 31 3448 9373
Email
klmnam789@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available