The effect of trans-theoretical model based physical activity training program on depression and anxiety in postmenopausal women
Design
Postmenopausal women with the characteristics identified by the health center are then divided into control and intervention groups. The intervention group is divided into two random subgroups. The groups are parallel and the study is single-blind followed by the first intervention group in 5 groups. The first session is taught and the second intervention group in the next 5 sessions
Settings and conduct
How to work: Physical activity training for eligible people who have been allowed to intervene and in the health centers 1 and 2 of Shahid Beheshti University and the control group because training does not belong to them is our blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Postmenopausal women with an age range of 56-45 years. Willingness to cooperate with the study. Have at least basic literacy (reading and writing). Living in the study area. Do not have specific diseases and disorders. Taking herbal or chemical remedies to reduce menopausal symptoms in the past 1 month, exercising professionally
Intervention groups
Educational intervention: At the beginning of the study, individuals are randomly divided into intervention or control groups, then the intervention group is divided into two subgroups. People in stages 1 to 3 of behavior change are in one group and people in the stages of operation and maintenance are in another group. The intervention group receives training based on a meta-theoretical model of physical activity.
Main outcome variables
The level of anxiety and depression, the stage of change in behavior related to physical activity and self-efficacy related to physical activity and the balance score of decision-making related to physical activity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200222046579N1
Registration date:2020-12-30, 1399/10/10
Registration timing:retrospective
Last update:2020-12-30, 1399/10/10
Update count:0
Registration date
2020-12-30, 1399/10/10
Registrant information
Name
Parisa Gholam bareshi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4261 3898
Email address
parisagholami1997@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-10, 1399/01/22
Expected recruitment end date
2020-07-05, 1399/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of trans-theoretical model based physical activity training program on depression and anxiety in Postmenopausal Women
Public title
the effect of physical activity training program on depression and anxiety in Postmenopausal Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Postmenopausal women aged 56-45 years
Elementary literacy (reading and writing)
Residence in the study area
No use of herbal or chemical drugs to reduce menopausal symptoms in the past 1 month
Exclusion criteria:
Having certain diseases and disorders that cause lifestyle changes or physical activity such as cancer, diabetes, cardiovascular disease, disability, respiratory distress
Exercise professionally
Age
From 45 years old to 56 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method and explanations: The stochasticization method is based on gradual references and having inclusion criteria and interest in participating in the study. Randomization unit: Individual Randomization layers: Random Allocation software type: Random Allocation software How to make a random sequence: Sequence Explanation about allocation concealment: Individuals included in the study, using a random method into two groups (intervention and control ) Are allocated. Randomization sequences will be generated based on 4 random permutation blocks using a web-based software. The randomization sequence will be provided to the project manager and will be hidden from the person participating in the study and the evaluator's colleague to enter the study until the intervention.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this single-blind study, only researchers are aware of which group of intervention and control individuals are in, and individuals are not aware of which type of training they receive.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2019-11-01, 1398/08/10
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.810
Health conditions studied
1
Description of health condition studied
depression and anxiety
ICD-10 code
F06.3
ICD-10 code description
Mood disorder due to known physiological condition
Primary outcomes
1
Description
Level of anxiety
Timepoint
Before training and after 6 months
Method of measurement
Depression and physical activity questionnaire
2
Description
Self-efficacy related to physical activity
Timepoint
Before training and after 6 months
Method of measurement
Depression and physical activity questionnaire
3
Description
Level of depression
Timepoint
Before training and after 6 months
Method of measurement
Depression and physical activity questionnaire
Secondary outcomes
1
Description
The amount of physical activity
Timepoint
Before and 6 months after training
Method of measurement
Questionnaire and number of correct answers
Intervention groups
1
Description
Intervention group 1: People who are in stages 1 to 3 of behavior change, training is 10 sessions per week, the first 5 sessions are held only for the first subgroup of the intervention and the next 5 sessions for all members of the intervention group. At the beginning, general information questionnaires, IPAQ physical activity and transtheoretical model constructs are completed for each person in person. The training is based on a transtheoretical model of physical activity. And at the end of each session, a summary of training is provided to individuals.
Category
Behavior
2
Description
Intervention group 2: People in the operation and maintenance stages, receiving 5 weekly training sessions, at the beginning of the work, general information questionnaires, IPAQ physical activity and transtheoretical model constructs for each person are completed in person. The training is based on a transtheoretical model of physical activity. And at the end of each session, a summary of training is provided to individuals.
Category
Behavior
3
Description
Control group: Control group: do not receive any training during the study.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti University of Medical Sciences ، Tehran North Health Center
Vice Chancellor for Research and Technology, 5th Floor, Building No. 2, Shahid Beheshti University of Medical Sciences and Health Services, Next to Taleghani Hospital, Shahid Ebays Arabi St., Yemen St., Shahid Chamran Highway،Tehran،Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parisa Gholam bareshi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 45, Abshar Alley, Valiasr St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1434743397
Phone
+98 51 4261 3898
Fax
Email
parisagholami1997@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parisa Gholam bareshi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 45, Abshar Alley, Valiasr St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1434743397
Phone
+98 51 4261 3898
Fax
Email
parisagholami1997@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parisa Gholam bareshi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 45, Abshar Alley, Valiasr St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1434743397
Phone
+98 51 4261 3898
Fax
Email
parisagholami1997@gmail.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