Public Health NursingNCT05482659
The Effect of Online Transtheoretic Model Based Health Education on Overweight University Students
A study testing Health education on healthy nutrition and regular physical activity based on the transtheoretic model in people with Public Health Nursing, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Aim: In this study, it was aimed to determine the effect of health education given to overweight university students based on the Transtheoretic Model (TTM) on nutrition and physical activity behaviors. Materials and Methods: The research was conducted in a randomized controlled experimental design. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Public Health Nursing
- What is being tested?
- Health education on healthy nutrition and regular physical activity based on the transtheoretic model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2021to 25 Feb 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Agreeing to participate in the research,
- University students without chronic diseases
- BMI level between 24.9 and 30,
- Open to communication and cooperation,
- Internet and smartphone/tablet/computer etc. owner.
Who cannot join
- BMI level of 24.9 and below,
- Using any drug,
- Who left the research voluntarily.
- Under the age of 18
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nuh Naci Yazgan University
Kayseri, Küme Evler Mahallesi, 38170
About this study
Official title: The Effect of Online Transtheoretic Model Based Health Education on Overweight University Students on Nutrition and Physical Activity Change Processes.
Aim: In this study, it was aimed to determine the effect of health education given to overweight university students based on the Transtheoretic Model (TTM) on nutrition and physical activity behaviors.
Materials and Methods: The research was conducted in a randomized controlled experimental design. The sample of the study consisted of 54 students, 27 of which were in the experimental group and 27 in the control group, who met the inclusion criteria between October 2021 and November 2021. Students were divided into nutrition and exercise change stages groups according to TTM. The students in the experimental group were given one-on-one health education in accordance with the TTM change stages, using the online method. In the study, data were collected using the Sociodemographic Form, Nutrition and Exercise Stage Determination Form according to TTM, Nutrition Change Processes Scale (NCPS) and Exercise Change Processes Scale (ECPS). Chi-square test and t test for dependent and independent groups were used in the analysis of the data obtained. Statistical significance level was accepted as p<0.05.
- Conditions
- Public Health Nursing
- Being tested
- Health education on healthy nutrition and regular physical activity based on the transtheoretic model
- Keywords
- transtheoretical model, Public Health Nursing, University Student
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education on healthy nutrition and regular physical activity based on the transtheoretic modelBehavioural
An announcement was made by visiting all the faculties at Nuh Naci Yazgan University, stating the content of the research and the duration of the research. Among the volunteer students, students who met the inclusion criteria were included in the study. Afterwards, the students were assigned to the groups by the statistician using a simple randomization method. As a result of the pre-test, it was determined which change stage each student was in according to the Transtheoretic model (TTM). The students were not given information about which group they were in and what stage they were in according to TTM. Health education was given to university students once a week by online education method and it took 4 weeks-30 days to complete the research. The average duration of the health education given to each student is 30-45 minutes. When the training process was over, the post-test questions were sent to the students by the online survey method.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Health education on healthy nutrition and regular physical activity based on the transtheoretic model was given to overweight university students in the experimental group once a week (every 4 weeks) using the online education method. Receives: Behavioral: Health education on healthy nutrition and regular physical activity based on the transtheoretic model |
| control group | No intervention | No attempt was made to the students in the control group during the intervention process. When the intervention process of the experimental group was finished, the materials used in health education were shared with the students. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stages of change according to the transtheoretic model - pre-intervention and post-intervention
The stages of change of the transtheoretic model were measured before and after the intervention to determine that university students changed their unhealthy diet and insufficient physical activity behaviors.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start25 Jun 2021
- Primary completion30 Nov 2021
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Public Health NursingStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CANSU YAŞAR, Saglik Bilimleri Universitesi
- Investigators
- Cansu Yaşar, 1, Principal investigator, cyasar@nny.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482659
- Sponsor's protocol ID
- SaglikBilimleriUniversity
- Status last verified
- Jul 2022
- First submitted
- 28 Jul 2022
- Last updated
- 1 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 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Online Transtheoretic Model Based Health Education on Overweight University Students on Nutrition and Physical Activity Change Processes.
- ClinicalTrials.gov ID
- NCT05482659
- Acronym / sponsor ID
- SaglikBilimleriUniversity
- Conditions
- Public Health Nursing
- Keywords
- transtheoretical model, Public Health Nursing, University Student
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 1 Aug 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.
Aim: In this study, it was aimed to determine the effect of health education given to overweight university students based on the Transtheoretic Model (TTM) on nutrition and physical activity behaviors.
Materials and Methods: The research was conducted in a randomized controlled experimental design. The sample of the study consisted of 54 students, 27 of which were in the experimental group and 27 in the control group, who met the inclusion criteria between October 2021 and November 2021. Students were divided into nutrition and exercise change stages groups according to TTM. The students in the experimental group were given one-on-one health education in accordance with the TTM change stages, using the online method. In the study, data were collected using the Sociodemographic Form, Nutrition and Exercise Stage Determination Form according to TTM, Nutrition Change Processes Scale (NCPS) and Exercise Change Processes Scale (ECPS). Chi-square test and t test for dependent and independent groups were used in the analysis of the data obtained. Statistical significance level was accepted as p<0.05.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Health education on healthy nutrition and regular physical activity based on the transtheoretic modelHealth education on healthy nutrition and regular physical activity based on the transtheoretic model was given to overweight university students in the experimental group once a week (every 4 weeks) using the online education method. |
| control group | No intervention | –No attempt was made to the students in the control group during the intervention process. When the intervention process of the experimental group was finished, the materials used in health education were shared with the students. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Agreeing to participate in the research,
- University students without chronic diseases
- BMI level between 24.9 and 30,
- Open to communication and cooperation,
- Internet and smartphone/tablet/computer etc. owner.
Key exclusion criteria (4 listed)
- BMI level of 24.9 and below,
- Using any drug,
- Who left the research voluntarily.
- Under the age of 18
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 |
|---|---|---|
| Health education on healthy nutrition and regular physical activity based on the transtheoretic modelAn announcement was made by visiting all the faculties at Nuh Naci Yazgan University, stating the content of the research and the duration of the research. Among the volunteer students, students who met the inclusion criteria were included in the study. Afterwards, the students were assigned to the groups by the statistician using a simple randomization method. As a result of the pre-test, it was determined which change stage each student was in according to the Transtheoretic model (TTM). The students were not given information about which group they were in and what stage they were in according to TTM. Health education was given to university students once a week by online education method and it took 4 weeks-30 days to complete the research. The average duration of the health education given to each student is 30-45 minutes. When the training process was over, the post-test questions were sent to the students by the online survey method. | Behavioural | Experimental |
Primary outcome
Stages of change according to the transtheoretic model - pre-intervention and post-intervention
Time frame: 4 weeks
The stages of change of the transtheoretic model were measured before and after the intervention to determine that university students changed their unhealthy diet and insufficient physical activity behaviors.
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 1 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.
Cansu Yaşar, 1 principal investigator
cyasar@nny.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education on healthy nutrition and regular physical activity based on the transtheoretic model in people with Public Health Nursing, run by Saglik Bilimleri Universitesi 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 5 inclusion and 4 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 1 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?
Stages of change according to the transtheoretic model - pre-intervention and post-intervention (time frame: 4 weeks). 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 1 Aug 2022.