- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05252793
Effect of Education Based on The Health Belief Model on Healthy Lifestyle Behaviors in Individuals With Type 2 Diabetes
Effect of Education Based on The Health Belief Model on Health Beliefs, Self-Efficacy and Healthy Lifestyle Behaviors in Individuals With Type 2 Diabetes
This research will be carried out with a randomized controlled experimental design to examine the effect of education based on the Health Belief Model for individuals with Type 2 Diabetes on their health beliefs, self-efficacy and healthy lifestyle behaviors.
During the research, the relevant polyclinic will be visited regularly. The patients who are followed up in the outpatient clinic for type 2 diabetes will be evaluated in terms of sampling eligibility criteria and their willingness to participate in the research will be questioned. The patients to be included in the study will be randomly assigned to intervention and control groups using the random sampling method. In determining the sample size, two groups, intervention and control, were compared using the "G*Power v3.1.9.4" program. Effect size (d) = 0.80, type I margin of error (α) = 0.05, minimum sample volume to provide test power (1-β) = 0.90, total 68 (experimental group 34, control group 34) is sick. However, it is planned to recruit 20% more patients (41 experiment, 41 control) in order to increase the power and reliability of the research, and there may be losses in the research process.
In the collection of research data; Introductory Characteristics Information Form, Diabetes Health Belief Model Scale, Diabetes Self-Efficacy Scale and Healthy Lifestyle Behaviors Scale-II will be applied.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Ankara, Turkey
- Sukru EKENLER
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Having been diagnosed with Type 2 Diabetes in the last 6 months
- Being between the ages of 18-65
- HbA1c ≥ 6.0%
- Taking oral antidiabetic medication and/or insulin therapy
- Understanding and speaking Turkish
- Being literate
- Living in Konya
- Not having a communication problem
- Being able to use the WhatsApp® application
- Not having internet access problems
- Individuals who agree to participate in the research by giving their verbal and written consent will be included.
Exclusion Criteria:
- Having a vision problem
- Having mental and communication problems
- Having a neuropsychiatric disorder
- Having a history of malignant disease
- Being pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diabetes Education Program Based on Health Belief Model
Experimental: Intervention Patients will be given links to training videos once or twice a week depending on the length of the training module for 6 weeks. At the 6th week, the Diabetes Patients Health Belief Model scale, the Diabetes Self-Efficacy Scale and the Healthy Lifestyle Scale-II will be administered as an interim measure. Health Belief Model scale in Diabetes Patients, Self-Efficacy Scale in Diabetes and Healthy Lifestyle Scale-II will be applied to the patients at the 12th week as the last measurement. |
After the intervention, it is expected that the scores of the patients on the healthy lifestyle behaviors scale will increase.
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No Intervention: Control
No intervention will be taken against the patients. At the 6th week, the Diabetes Patients Health Belief Model scale, the Diabetes Self-Efficacy Scale and the Healthy Lifestyle Scale-II will be administered as an interim measure. Health Belief Model scale in Diabetes Patients, Self-Efficacy Scale in Diabetes and Healthy Lifestyle Scale-II will be applied to the patients at the 12th week as the last measurement. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healthy Lifestyle Behaviors Scale II Score Change
Time Frame: pre-test (week 1), post-test (week 12)
|
Healthy Lifestyle Behaviors Scale II Score Change from Baseline Healthy Lifestyle Behaviors Scale II Score at 12 weeks
|
pre-test (week 1), post-test (week 12)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health Belief Model Questionnaire
Time Frame: pre-test (week 1), post-test (week 12)
|
Change in perceived severity, perceived susceptibility, perceived benefits, perceived barriers scores at 12 weeks
|
pre-test (week 1), post-test (week 12)
|
|
Self-Efficacy Questionnaire
Time Frame: pre-test (week 1), post-test (week 12)
|
Change from Baseline self-efficacy level scores at 12 weeks
|
pre-test (week 1), post-test (week 12)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 178536431
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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