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CompletedNCT05252793Updated Aug 3, 2022

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

An interventional study of Education based on the health belief model in Type 2 Diabetes, sponsored by Gazi University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-08-03.

Sponsored by Gazi University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • Self Efficacy
  • Healthy Lifestyle
  • Health Belief Model
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 82 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Gazi University is the lead sponsor of 531 studies on the registry; 99 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

Exclusion Criteria:

  • Having a vision problem
  • Having mental and communication problems
  • Having a neuropsychiatric disorder
  • Having a history of malignant disease
  • Being pregnant
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
82 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralEducation 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: pre-test (week 1), post-test (week 12)

Secondary outcomes

  1. Health Belief Model Questionnaire

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

    Time frame: pre-test (week 1), post-test (week 12)

  2. Self-Efficacy Questionnaire

    Change from Baseline self-efficacy level scores at 12 weeks

    Time frame: pre-test (week 1), post-test (week 12)

07

Study locations

1 site
  • Sukru EKENLER
    Ankara, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05252793
Lead sponsor
Gazi University
Responsible party
Sukru Ekenler (Instructor, Gazi University) — Principal investigator
First posted
Feb 23, 2022
Start date
Jan 1, 2022
Primary completion
Jun 30, 2022
Completion
Jul 1, 2022
Last update
Aug 3, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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