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

Sponsor
Gazi University (Other)
Overall Status
Completed
CT.gov ID
NCT05252793
Collaborator
(none)
82
1
2
5.9
13.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Education based on the health belief model
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jan 1, 2022
Actual Primary Completion Date :
Jun 30, 2022
Actual Study Completion Date :
Jul 1, 2022

Arms and Interventions

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.

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Healthy Lifestyle Behaviors Scale II Score Change [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

Secondary Outcome Measures

  1. Health Belief Model Questionnaire [pre-test (week 1), post-test (week 12)]

    Change in perceived severity, perceived susceptibility, perceived benefits, perceived barriers scores at 12 weeks

  2. Self-Efficacy Questionnaire [pre-test (week 1), post-test (week 12)]

    Change from Baseline self-efficacy level scores at 12 weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sukru EKENLER Ankara Turkey

Sponsors and Collaborators

  • Gazi University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sukru Ekenler, Instructor, Gazi University
ClinicalTrials.gov Identifier:
NCT05252793
Other Study ID Numbers:
  • 178536431
First Posted:
Feb 23, 2022
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sukru Ekenler, Instructor, Gazi University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2022