Effect of Education Based on The Health Belief Model on Healthy Lifestyle Behaviors in Individuals With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Effect of Education Based on The Health Belief Model on Health Beliefs, Self-Efficacy and Healthy Lifestyle Behaviors in Individuals With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05252793
• Other study ID #: 178536431
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: July 1, 2022

Study information

• Verified date: August 2022
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: July 1, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Education based on the health belief model
After the intervention, it is expected that the scores of the patients on the healthy lifestyle behaviors scale will increase.

Locations

Country	Name	City	State
Turkey	Sukru EKENLER	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healthy Lifestyle Behaviors Scale II Score Change	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	Health Belief Model Questionnaire	Change in perceived severity, perceived susceptibility, perceived benefits, perceived barriers scores at 12 weeks	pre-test (week 1), post-test (week 12)
Secondary	Self-Efficacy Questionnaire	Change from Baseline self-efficacy level scores at 12 weeks	pre-test (week 1), post-test (week 12)