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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Education based on the health belief model
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring Self Efficacy, Healthy Lifestyle, Health Belief Model

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sukru EKENLER

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Diabetes Education Program Based on Health Belief Model

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Health Belief Model Questionnaire
Change in perceived severity, perceived susceptibility, perceived benefits, perceived barriers scores at 12 weeks
Self-Efficacy Questionnaire
Change from Baseline self-efficacy level scores at 12 weeks

Full Information

First Posted
February 14, 2022
Last Updated
August 2, 2022
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05252793
Brief Title
Effect of Education Based on The Health Belief Model on Healthy Lifestyle Behaviors in Individuals With Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Self Efficacy, Healthy Lifestyle, Health Belief Model

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diabetes Education Program Based on Health Belief Model
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education based on the health belief model
Intervention Description
After the intervention, it is expected that the scores of the patients on the healthy lifestyle behaviors scale will increase.
Primary Outcome Measure Information:
Title
Healthy Lifestyle Behaviors Scale II Score Change
Description
Healthy Lifestyle Behaviors Scale II Score Change from Baseline Healthy Lifestyle Behaviors Scale II Score at 12 weeks
Time Frame
pre-test (week 1), post-test (week 12)
Secondary Outcome Measure Information:
Title
Health Belief Model Questionnaire
Description
Change in perceived severity, perceived susceptibility, perceived benefits, perceived barriers scores at 12 weeks
Time Frame
pre-test (week 1), post-test (week 12)
Title
Self-Efficacy Questionnaire
Description
Change from Baseline self-efficacy level scores at 12 weeks
Time Frame
pre-test (week 1), post-test (week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sukru EKENLER
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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