NCT05252793

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

February 14, 2022

Last Update Submit

August 2, 2022

Conditions

Keywords

Self EfficacyHealthy LifestyleHealth Belief Model

Outcome Measures

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

    pre-test (week 1), post-test (week 12)

Secondary Outcomes (2)

  • Health Belief Model Questionnaire

    pre-test (week 1), post-test (week 12)

  • Self-Efficacy Questionnaire

    pre-test (week 1), post-test (week 12)

Study Arms (2)

Diabetes Education Program Based on Health Belief Model

EXPERIMENTAL

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

Control

NO INTERVENTION

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

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

Diabetes Education Program Based on Health Belief Model

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sukru EKENLER

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

February 14, 2022

First Posted

February 23, 2022

Study Start

January 1, 2022

Primary Completion

June 30, 2022

Study Completion

July 1, 2022

Last Updated

August 3, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations