The Effect of Education Given to Type 2 Diabetics on Diabetes Self-management, Health Fatalism and Metabolic Parameters

February 23, 2025 updated by: Gülşen Altuntas Çalım, Ataturk University

The Effect of Training with Motivational Interviewing Based on Health Belief Model on Diabetes Self-Management, Health Fatalism and Metabolic Parameters in Individuals with Type 2 Diabetes: a Randomized Controlled Experimental Study

This study aims to examine the effects on diabetes self-management, health fatalism and metabolic parameters of individuals with type 2 diabetes. The study will be conducted in a health institution between February 2025 and May 2025 and participants will be assigned to experimental and control groups by simple random sampling method. The experimental group will be trained with motivational interviewing techniques based on the health belief model for 8 weeks, followed by sending reminder SMS for 4 weeks. The control group will receive no intervention. The study is expected to improve the self-care behaviors of individuals with diabetes by creating positive effects on diabetes management and health fatalism.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to determine the effect of education given with motivational interviewing technique structured according to the health belief model on diabetes self-management, health fatalism and metabolic parameters in individuals with type 2 diabetes. The research will be conducted in a pre-test and post-test randomized controlled experimental design.The population of the study will consist of individuals with type 2 diabetes who are registered in a health institution between February 2025 and May 2025 and who meet the research criteria. The sample determined by power analysis will consist of a total of 66 patients, 33 in the experimental group and 33 in the control group. Patient Introduction Form, Type 2 DM Self-Management Scale (SMS) and Health Fatalism Scale will be used to collect data from the experimental and control groups for pre-test and post-test. Weight, height, waist circumference and body mass index of the individuals will be measured by the researcher and HbA1c values of the last one month will be recorded. The experimental group will be given diabetes education with motivational interviewing technique structured according to the health belief model in line with the literature.Brochures and powerpoint presentations will be prepared as training materials. Trainings will be held in the training room on the days and times determined with the patients in 8 sessions lasting 30-40 minutes. At the end of the training, an SMS message will be sent once a week for four weeks. At the end of each visit, the next visit will be scheduled. Trainings will be conducted face-to-face by the researcher. The control group will not receive any training. After the completion of the trainings, a post-test will be administered to both the experimental and control groups. In the evaluation of the data; numbers, percentages, standard deviation, mean, minimum and maximum values, Chi-square, Fisher-Freeman-Halton Exact Test, Paired Samples t-test and Independent Samples t-test will be used.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Antalya, Turkey, 07000
        • Recruiting
        • Manavgat and Aksu Family Health Center
        • Contact:
      • Antalya, Turkey
        • Recruiting
        • Manavgat and Aksu Family Health Center
        • Contact:
        • Contact:
          • Gülşen ALTUNTAŞ ÇALIM, PhD student
        • Contact:
          • CANTÜRK ÇAPIK, PROF. DR.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Having type 2 diabetes for at least 6 months
  • To be over 18 years old
  • Have sufficient communication skills to answer verbal and written questions and fulfill instructions
  • Becoming literate
  • No physical, cognitive or mental impairment in answering the questions
  • Willingness to participate in research.

Exclusion Criteria:

  • Under 18 years of age
  • Being hospitalized in inpatient treatment institutions due to DM or DM complications during the research process
  • The emergence of any health problem that prevents the person from continuing the research
  • Do not leave the study voluntarily.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group receiving diabetes education with motivational interviewing technique
Patient Introduction Form, Type 2 DM Self-Management Scale (SMS) and Health Fatalism Scale will be applied to the experimental group before the training. then, diabetes education will be given to the individuals in the experimental group one day a week with the motivational interviewing technique based on the health belief model. 8 weeks of training will be given in total and then 4 weeks of informative reminder sms will be sent about diabetes education. After the training is over, Patient Introduction Form, Type 2 DM Self-Management Scale (SMS) and Health Fatalism Scale will be applied.
Other: Experimental Group
individuals will receive diabetes education with motivational interviewing technique based on health belief model
No Intervention: group with no intervention
The control group will be administered the Patient Introduction Form, Type 2 DM Self-Management Scale (SMS) and Health Fatalism Scale at the first encounter. After 3 months, the Patient Introduction Form, Type 2 DM Self-Management Scale (SMS) and Health Fatalism Scale will be applied again. No application will be made to the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type 2 DM Self-Management Scale (SMS)
Time Frame: three months

The scale assesses self-management It has 3 sub-dimensions.These dimensions consist of 11 questions consisting of "Healthy Lifestyle Behaviors" dimension, consisting of 4 questions "Health Services Utilization" dimension and "Blood Sugar Management" dimension. Scoring: Always 5, Often 4, Sometimes 3, Rarely 2, Never 1.

(-Healthy Lifestyle Subdimension= HLBD-1+ HLBD-2+ HLBD-3+ HLBD-4+ HLBD-5+ HLBD-6+ HLBD-7+ SYBD-8+ SYBD-9+ SYBD-10+ SYBD-11.) (-Blood Glucose Management Subscale= BSM-1+ BSM-2+ BSM-3+ BSM-4) (-Health Services Utilization Subdimension= SHK-1+ SHK-2+ SHK-3+ SHK-4) (-Diabetes Self-Management Scale score=SMDI Subdimension+CSM Subdimension +SCC Subdimension.) There are no reverse items in the scale. High scores indicate good self-management, low scores indicate and poor self-management. The minimum score that can be obtained from the Type 2 self-management scale is 19 and the maximum score is 95.
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Fatalism Scale
Time Frame: three months
The scale consists of one sub-dimension and 17 items. The scale is a Likert-type scale answered as ''strongly disagree'', ''disagree'', ''undecided'', ''agree'', ''strongly agree''. The minimum score obtained from the Health Fatalism Scale is 17 and the maximum score is 85. Cronbach α Coefficient of the scale is 0.91.An increase in the score on the scale indicates an increase in fatalism.
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 23, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU-SBF-GAÇ-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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