Investigating the effect of implementing an educational program based on King's goal achievement model on health-promoting behaviors and life satisfaction in type 2 diabetic patients
Determining the effect of implementing an educational program based on King's goal achievement model on health-promoting behaviors and life satisfaction in type 2 diabetes patients.
Design
This study will be a randomized clinical trial study without blinding, which aims to investigate the effect of implementing an educational program based on the model of achieving King's goal on health-promoting behaviors and life satisfaction in type 2 diabetes patients.
Settings and conduct
This study will be a randomized clinical trial study without blinding, with the aim of investigating the effect of implementing an educational program based on the King's goal achievement model on health-promoting behaviors and life satisfaction in type 2 diabetes patients.
The research population will be type 2 diabetic patients referring to the diabetes clinic of Jahrom city in the south of Fars province.
Participants/Inclusion and exclusion criteria
60 patients with type 2 diabetes will be randomized into two intervention and control groups. Entry criteria include being literate, not having acute and chronic mental and psychological diseases, and age between 30 and 55 years. Exclusion criteria will include worsening of the disease, death of the patient, and withdrawal from the study for any reason.
Intervention groups
The intervention group will receive 7 training sessions
Main outcome variables
Behaviors that promote health and life satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190917044802N8
Registration date:2022-12-16, 1401/09/25
Registration timing:registered_while_recruiting
Last update:2022-12-16, 1401/09/25
Update count:0
Registration date
2022-12-16, 1401/09/25
Registrant information
Name
Mostafa Bijani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5331 5012
Email address
bizhani_mostafa@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-16, 1401/09/25
Expected recruitment end date
2023-02-14, 1401/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of implementing an educational program based on King's goal achievement model on health-promoting behaviors and life satisfaction in type 2 diabetic patients
Public title
The effect of implementing an educational program based on health-promoting behaviors and life satisfaction in diabetic patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having literacy
Not having acute and chronic mental and psychological diseases
Age between 30 and 55 years
Exclusion criteria:
Worsening of the disease
death of the patient
Withdrawal from the study for any reason
Age
From 30 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
30
30 people in the intervention group and 30 people in the control group25
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with type 2 diabetes will be selected as convenience, and then randomly divided into intervention and control groups. For the purpose of random allocation, 60 cards were placed inside a sealed envelope and the patients were asked to randomly pick one card. Patients who take card A are in the intervention group and patients who take card B are in the control group.
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 Fasa University of Medical Sciences
Street address
7461686688, Fasa University of Medical Sciences, Ibn Sina Square, Fasa, Fars, Iran.
City
FASA
Province
Fars
Postal code
7461686688
Approval date
2022-11-06, 1401/08/15
Ethics committee reference number
IR.FUMS.REC.1401.124
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Health promoting lifestyle
Timepoint
Before, immediately and three months later
Method of measurement
Walker health promoting lifestyle questionnaire
2
Description
Life satisfaction
Timepoint
Before, immediately and three months later
Method of measurement
Diner life satisfaction questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group: training will be conducted through seven one-hour sessions in the form of group discussions, training pamphlets, lectures and educational PowerPoint for the intervention group.
Category
Lifestyle
2
Description
Control group: The control group will only receive the training package and will not receive the training intervention
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali Asr Fasa Hospital
Full name of responsible person
Mostafa Bijani
Street address
7461686688, Fasa University of Medical Sciences, Ibn Sina Square, Fasa, Fars, Iran
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 2220 9946
Email
bizhani_mostafa@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Yasser Mansouri
Street address
7461686688, Fasa University of Medical Sciences, Ibn Sina Square, Fasa, Fars, Iran.
City
FASA
Province
Fars
Postal code
7461686688
Phone
+98 71 2220 9946
Email
mansouri@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Mostafa bijani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
7461686688, Fasa University of Medical Sciences, Ibn Sina Square, Fasa, Fars, Iran.
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 2220 9946
Fax
Email
bizhani_mostafa@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bijani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
7461686688, Fasa University of Medical Sciences, Ibn Sina Square, Fasa, Fars, Iran.
City
Fasa
Province
Fars
Postal code
7461686688,
Phone
+98 71 2220 9946
Email
bizhani_mostafa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bijani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
7461686688, Fasa University of Medical Sciences, Ibn Sina Square, Fasa, Fars, Iran.
City
FASA
Province
Fars
Postal code
7461686688
Phone
071220994-6
Email
bizhani_mostafa@yahoo.com
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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Authors can send their request to use the research results and statistical data to the responsible author.
When the data will become available and for how long
After the article is published and printed, the requested information will be provided to other authors
To whom data/document is available
After the article is published and printed, the requested information will be provided to other authors
Under which criteria data/document could be used
Authors can send their request to use the research results and statistical data to the responsible author.
From where data/document is obtainable
The request should be sent to the responsible author's email
bizhani_mostafa@yahoo.com
What processes are involved for a request to access data/document
Authors can send their request to use the research results and statistical data to the responsible author.