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Completed

NCT Number: NCT05252793

Effect of Education Based on The Health Belief Model on 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sukru EKENLER

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education based on the health belief model

Behavioral

After the intervention, it is expected that the scores of the patients on the healthy lifestyle behaviors scale will increase.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Self-Efficacy Questionnaire

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

    Change from Baseline self-efficacy level scores at 12 weeks

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2022
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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