Determining the impact of participation-based empowerment program on blood sugar levels, physical activity and nutritional behaviors in prediabetic people
Design
A clinical trial with a control group, with parallel groups, single-blind, on 82 patients, drawing a card was used for randomization
Settings and conduct
This study will be conducted in the form of a field trial on 82 prediabetic people with entry criteria in 4 comprehensive health service centers affiliated to No. 1 in Mashhad in a simple random and single-blind manner. The intervention program of 6 sessions of 45-60 minutes will be held for people with pre-diabetes and their family caregivers. The educational content will include the importance of blood sugar control, regular physical activity, dietary compliance and stress management methods. The collaborative program has three stages of educational and support needs assessment, support planning and evaluation
Participants/Inclusion and exclusion criteria
Criteria for entering the study (for pre-diabetics):
Age 18-59 years; Having a health record in the health center; Having a family caregiver interested in participating in the study; Ability to read and write; The ability to use a smart phone; Absence of pregnancy for female clients; Blood sugar between 100 and 125 mg/dL; Lack of employment in medical science professions;
Non-entry criteria
Fasting blood sugar more than 126 mg/dL; Lack of literacy
Intervention groups
The intervention program is 6 sessions of 45-60 minutes. The educational content will include the importance of blood sugar control, regular physical activity, dietary compliance and stress management methods.
The control group will receive 4 training sessions of 30-60 minutes by health care workers.
The Effect of participation-based empowerment program on blood sugar level, physical activity, and nutritional behaviors in pre-diabetic people
Public title
The Effect of participation-based empowerment program on blood sugar level, physical activity, and nutritional behaviors in pre-diabetic people
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-59 years
Having a health record in the health center
Having a family caregiver interested in participating in the study
Ability to read and write
The ability to use a smart phone
Absence of pregnancy for female clients
Blood sugar between 100 and 125 mg/dL
Lack of employment in medical science professions
Exclusion criteria:
Fasting blood sugar more than 126 mg/dL
Lack of literacy
Age
From 18 years old to 59 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
At first, among the 20 health centers affiliated to Mashhad Health Center No. 1, 4 centers will be selected based on the goal. These four centers will have the same social and economic conditions. Then a code is assigned to each of these centers and the sheets with the codes written on them will be placed in a sealed envelope. An observer will then be asked to remove the papers from the envelope. The first and third papers will be assigned to the intervention group and the second and fourth papers will be assigned to the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyst will not know which of the intervention or control groups the information is related to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Azadi Square, Mashhad Medical Sciences Campus
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2023-09-20, 1402/06/29
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.076
Health conditions studied
1
Description of health condition studied
prediabets
ICD-10 code
R73.0
ICD-10 code description
Abnormal glucose
Primary outcomes
1
Description
Blood sugar
Timepoint
In the study, blood sugar measurement will be done before the study, during the study and one month after the study.
Method of measurement
Blood sugar will be measured using laboratory fasting blood sugar measurement
2
Description
physical activity
Timepoint
Before the study and one month after the intervention
Method of measurement
With International Physical Activity Questionnaire(IPAQ)
3
Description
Nutritional behaviors
Timepoint
Before the study and one month after the intervention
Method of measurement
Nutritional behaviors will be measured using the Diabetes Self-Management Questionnaire for Pre-diabetes
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention program of 6 sessions of 45-60 minutes will be held for people with pre-diabetes and their family caregivers. The educational content will include the importance of blood sugar control, regular physical activity, dietary compliance and stress management methods
Category
Prevention
2
Description
Control group: In the control group, all the educational content will be provided to them and in addition, 4 training sessions of 30-60 minutes will be held by health care workers for this group and their questions will be answered in this field. Before and after the sessions, diabetes self-care questionnaire and IPAQ, as well as fasting blood sugar will be measured before and after
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health service centers affiliated to the number one health center
Full name of responsible person
Dr. Baratali Arabnejad
Street address
Iqbal, Vakil Abad Highway
City
Mashhad
Province
Razavi Khorasan
Postal code
9179793945
Phone
+98 51 3501 8011
Email
pr@mums.ac.ir.hc1
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayor Mobarhan
Street address
Azadi Square, Mashhad Medical Sciences Campus
City
Mashhad
Province
Razavi Khorasan
Postal code
9919191778
Phone
+98 51 3841 2081
Email
presidentoffice@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
50
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
Mashhad University of Medical Sciences
Full name of responsible person
Hamidreza Zendehtalab
Position
consultant
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Azadi Square, East Gate of Ferdowsi University of Mashhad, Shahid Kharazmi Educational Complex
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
zendehtalabHR@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamidreza Zendehtalab
Position
consultant
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Azadi Square, East Gate of Ferdowsi University of Mashhad, Shahid Kharazmi Educational Complex
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
zendehtalabHR@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elham Bagheri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.90, Meshkini Ave 5, Andisheh 71,Ghasemabad
City
Mashhad
Province
Razavi Khorasan
Postal code
9185344618
Phone
+98 51 3623 2902
Fax
Email
bagherie4012@mums.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