Type 2 DiabetesNCT05252793
Effect of Education Based on The Health Belief Model on Healthy Lifestyle Behaviors in Individuals With Type 2 Diabetes
A study testing Education based on the health belief model in people with Type 2 Diabetes, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Education based on the health belief model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- Having a vision problem
- Having mental and communication problems
- Having a neuropsychiatric disorder
- Having a history of malignant disease
- Being pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Education based on the health belief model
- Keywords
- Self Efficacy, Healthy Lifestyle, Health Belief Model
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education based on the health belief modelBehavioural
After the intervention, it is expected that the scores of the patients on the healthy lifestyle behaviors scale will increase.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: pre-test (week 1), post-test (week 12)
Secondary outcomes (2)
Health Belief Model Questionnaire
Change in perceived severity, perceived susceptibility, perceived benefits, perceived barriers scores at 12 weeks
Measured: pre-test (week 1), post-test (week 12)
Self-Efficacy Questionnaire
Change from Baseline self-efficacy level scores at 12 weeks
Measured: pre-test (week 1), post-test (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Jan 2022
- Primary completion30 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sukru Ekenler, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252793
- Sponsor's protocol ID
- 178536431
- Status last verified
- Aug 2022
- First submitted
- 14 Feb 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05252793
- Acronym / sponsor ID
- 178536431
- Conditions
- Type 2 Diabetes
- Keywords
- Self Efficacy, Healthy Lifestyle, Health Belief Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes Education Program Based on Health Belief Model | Experimental | Behavioral: Education based on the health belief modelExperimental: 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- Having a vision problem
- Having mental and communication problems
- Having a neuropsychiatric disorder
- Having a history of malignant disease
- Being pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education based on the health belief modelAfter the intervention, it is expected that the scores of the patients on the healthy lifestyle behaviors scale will increase. | Behavioural | Diabetes Education Program Based on Health Belief Model |
Primary outcome
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
2 secondary outcomes
Health Belief Model Questionnaire
Time frame: pre-test (week 1), post-test (week 12)
Self-Efficacy Questionnaire
Time frame: pre-test (week 1), post-test (week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education based on the health belief model in people with Type 2 Diabetes, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy Lifestyle Behaviors Scale II Score Change (time frame: pre-test (week 1), post-test (week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.