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

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: Type 2 Diabetes; Type 2 Diabetes Patients
• Intervention / Treatment: Other: Experimental Group

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

• Study Contact: Name: Gülşen Altuntaş Çalım, PhD student; Phone Number: +905535383055; Email: gulsenaltuntas13@hotmail.com
• Study Contact Backup: Name: Cantürk Çapık, Prof. dr.; Phone Number: +90 442 231 2686; Email: canturk@atauni.edu.tr

Study Locations

• Turkey
  • Antalya, Turkey, 07000
    • Recruiting
    • Manavgat and Aksu Family Health Center
    • Contact: Gülşen Altuntaş Çalım; Phone Number: +905535383055; Email: gulsenaltuntas13@hotmail.com
  • Antalya, Turkey
    • Recruiting
    • Manavgat and Aksu Family Health Center
    • Contact: Gülşen Altuntaş Çalım, PhD student; Phone Number: +905535383055; Email: gulsenaltuntas13@hotmail.com
    • Contact: Gülşen ALTUNTAŞ ÇALIM, PhD student
    • Contact: CANTÜRK ÇAPIK, PROF. DR.

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	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	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

• Sponsor: Ataturk University

Study record dates

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: self-management; type 2 diabetes; motivational interview; health belief model; health fatalism
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• 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