Determination of effect of lifestyle modification based on Health Belief Model on bone density in middle-aged women with osteopenia
Design
Clinical trial with two intervention groups, in parallel groups, single blind, randomized with simple method, with sample size 64
Settings and conduct
This study is a randomized controlled clinical trial that the population of this study is middle-aged women referred to Isfahan Oil Company clinic.
After estimating the sample size, 4 training sessions of 40-60 minutes for 4 consecutive weeks will be conducted with the aim of adjusting the lifestyle based on Health Belief Model on bone density in middle-aged women with osteopenia for the intervention group. Before the intervention, both control and intervention groups will complete the questionnaire. These questionnaires will also be completed by the same participants six months after the first training session.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Middle-aged women (40-55 years); According to the BMD in the case file, they have osteopenia; Not postmenopausal; Do not use corticosteroids or chemotherapy drugs for up to a year before taking the study; Do not use anti-osteoporotic drugs; Do not suffer from any rheumatic diseases, types of cancer and bone metastasis, thyroid and parathyroid problems, and bone fractures, which will be done by referring to patients' electronic records; Tend to be involved in research; Exclusion criteria: Not to be a client of Isfahan Oil Company clinic; Do not reside in Isfahan.
Intervention groups
The intervention group attends training sessions and the control group will receive only pamphlets.
Investigation of the effect of lifestyle modification based on Health Belief Training Model on bone density in middle-aged women with osteopenia
Public title
The effect of lifestyle modification on bone density in middle-aged women with osteopenia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Middle-aged women (40-55 years)
According to the Bone Mineral Density (BMD) in the case file, they have osteopenia.
Not postmenopausal.
Do not use corticosteroids or chemotherapy drugs for up to a year before taking the study.
Do not use anti-osteoporotic drugs.
Do not suffer from any rheumatic diseases, types of cancer and bone metastasis, thyroid and parathyroid problems, and bone fractures, which will be done by referring to patients' electronic records.
Tend to be involved in research.
Exclusion criteria:
Not to be a client of Isfahan Oil Company clinic.
Do not reside in Isfahan.
Age
From 40 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
The study sample was simple randomly divided into two groups of 32 people, each by selective envelopes. Thus, each envelope containing one of the two A and B labels represented one of the groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahn University of Medical Sciences, Hezar Jarib st, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2019-03-12, 1397/12/21
Ethics committee reference number
IR.MUI.MED.REC.1397.338
Health conditions studied
1
Description of health condition studied
Osteoporosis
ICD-10 code
M81
ICD-10 code description
Osteoporosis without current pathological fracture
Primary outcomes
1
Description
Knowledge
Timepoint
Before and after the study
Method of measurement
Questionnaire
2
Description
Attitude
Timepoint
Before and after the study
Method of measurement
Questionnaire
3
Description
Perceived sensitivity
Timepoint
Before and after the study
Method of measurement
Questionnaire
4
Description
Perceived severity
Timepoint
Before and after the study
Method of measurement
Questionnaire
5
Description
Perceived benefits
Timepoint
Before and after the study
Method of measurement
Questionnaire
6
Description
Perceived barriers
Timepoint
Before and after the study
Method of measurement
Questionnaire
7
Description
Guidelines for action
Timepoint
Before and after the study
Method of measurement
Questionnaire
8
Description
Urinary telopeptide
Timepoint
Before and after the study
Method of measurement
Questionnaire
9
Description
Physical activity
Timepoint
Before and after the study
Method of measurement
Questionnaire
10
Description
Calcium intake
Timepoint
Before and after the study
Method of measurement
Questionnaire
11
Description
Vitamin D intake
Timepoint
Before and after the study
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: four 40-60 minute training sessions for consecutive weeks, aimed at modifying lifestyle based on health belief model on bone density in middle-aged women with osteopenia. Meetings will be as group meetings and question and answer session on osteoporosis complications, the ways to reduce it, the importance of vitamin D and calcium absorption, and daily activity.
Category
Lifestyle
2
Description
Control group: This group received only pamphlets containing amounts of calcium and vitamin D in food and no training session.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Oil Company Clinic
Full name of responsible person
Ziba Farajzadegan
Street address
Isfahan University of Medical Sciences, Hezar Jarib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
farajzadegan@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Isfahan University of Medical Sciences, Hezar jarib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
sh_haghjoo@med.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
Ziba Farajzadegan
Position
Professor of Community Medicine
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Isfahan University of Medical Sciences, Hezar jarib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
farajzadegan@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Farajzadegan
Position
Professor of Community Medicine
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Isfahan University of Medical Sciences, Hezar jarib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
farajzadegan@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Farajzadegan
Position
Professor of Community Medicine
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jarib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
farajzadegan@med.mui.ac.ir
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
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