ObesityNCT04195516
Improving Healthy Nutrition and Physical Activity Behaviors of University Students
A study testing web based training,individual counseling, using reminders in people with Obesity and Students, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
There are many descriptive studies in the literature on health behaviors of university youth.However, there are a limited number of model-based interventional studies explaining the development of positive health behaviors of students in the university period.In this context, this study "Applied to University Students… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- What is being tested?
- web based training,individual counseling, using reminders
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to Dec 2020
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Students with body mass indexes between 25-35 kg / m² Nutritional behavior of students with a mean score of 2 and below Students who do not do regular physical activity
Who cannot join
- Students who have problems with musculoskeletal system, cardiopulmonary system, metabolic system and other systems that will prevent exercise will not be accepted.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İstanbul Medipol Üniversitesi
Istanbul
Ayşe Dost, Lecturer, 5076506238, adost@medipol.edu.tr
About this study
Official title: The Effect of Health Promotion Program Applied to University Students on Improving Healthy Nutrition and Physical Activity Behaviors
There are many descriptive studies in the literature on health behaviors of university youth.However, there are a limited number of model-based interventional studies explaining the development of positive health behaviors of students in the university period.In this context, this study "Applied to University Students The aim of this study will be to determine the Impact of Health Promotion Program on Developing Healthy Nutrition and Physical Activity Behaviors.This study was planned as a randomized controlled experimental study to determine the effect of the health promotion program applied to university students on the development of healthy eating and physical activity behaviors. The general population of the study will be composed of students enrolled in a formal education program at Istanbul Medipol University between January and September 2019.
The study population will consist of students with a body mass index between 25-35 kg / m², a mean nutritional behavior score of 2 or less, no regular physical activity, and no musculoskeletal, cardiopulmonary, metabolic or other systemic problems that prevent exercise.The sample size was calculated by power analysis. In the calculation, 0,80 power value, 0,05 error level, 0,60 'relationship is predicted, sampling 45 students to the experiment, 45 students to the control group was found to be appropriate. Experimental and control groups will be appointed by making probable selection from the study universe. In the study process, 10 substitutes were selected considering that there could be subjects who could leave the research. After all; 55 people in the experimental group and 55 people in the control group were selected by sampling. The sample consisted of 110 students.
Read the detailed description
- In order to identify the risky students in the study universe, a stand will be opened in the most crowded area and the most frequently used area of the campus.
- As a result of the screening, body mass indexes are between 25-35 kg / m², nutritional behavior score is 2 or less, do not perform regular physical activity and do not have problems related to musculoskeletal system, cardiopulmonary system, metabolic system and other systems. Students will be admitted to the study universe.
- Assignment will be made to the experimental and control groups by making probable selection from the study population.
- Measurements of physical and cognitive variables of experimental and control groups will be made.
- Health Promotion Modeled Health Promotion Program (Annex-1) will be applied to the experimental group. Health promotion program; The Web-based Health Promotion Program includes individual counseling and reminder practices. The content of the Web Based Health Promotion Program is given in Annex-2. The control group will be given educational brochures to develop healthy eating and physical activity behaviors.
- Measurements of physical and cognitive variables of experimental and control groups at 1st, 3rd and 6th months will be made.
- The data will be analyzed and evaluated statistically.
- Report will be written.
- Being tested
- web based training,individual counseling, using reminders
- Keywords
- health promotion, university students, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web based training,individual counseling, using remindersOther
Health Promotion Model based Health Promotion Program will be applied to the experimental group. Health promotion program; The Web-based Health Promotion Program includes individual counseling and reminder practices.
Within the context of the Web Based Health Promotion Program, 8 weeks of training to improve healthy eating and physical activity behaviors, individual counseling will be given.
Colorful picture reminders will be sent to the experimental group through Whatsapp groups.
At the end of the intervention, cognitive and physical measurements of the students will be done at 1st, 3rd and 6th months.
| Study group | Role | What they receive |
|---|---|---|
| Health Promotion Group | Experimental | Experimental group will be applied Health Promotion Model Basic Health Promotion Program. Health promotion program; The Web-based Health Promotion Program includes individual counseling and reminder practices. Receives: Other: web based training,individual counseling, using reminders |
| Control Group | No intervention | The control group will be given educational brochures to develop healthy eating and physical activity behaviors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activity variables
Post-intervention BMI and weight average of students participating in health promotion model based health promotion program will be lower than pre-program and non-program group.
Measured: start, 1st, 3rd, 6th month
Secondary outcomes (8)
nutrition behaviors variables
The average number of meals consumed by the students who participated in the health promotion model based health promotion program after the initiative will be higher than the pre-program and non-program group.
Measured: start, 1st, 3rd, 6th month
nutrition behaviors variables-2
The daily drinking water amount of students participating in the health promotion model based health promotion program will be higher than the pre-program and non-program group.
Measured: start, 1st, 3rd, 6th month
physical activity variables-2
The average number of weekly steps of students participating in the health promotion model based health promotion program will be higher than the pre-program and non-program group.
Measured: start, 1st, 3rd, 6th month
nutrition behaviors variables-3
The average carbohydrate consumption consumed by the students participating in the health promotion model based health promotion program will be lower than the pre-program and non-program group consumed.
Measured: start, 1st, 3rd, 6th month
physical activity variables-3
International Physical Activity Questionnaire (IPAQ) score of students participating in health promotion model based health promotion program will be higher than pre-program and non-program group.
Measured: start, 1st, 3rd, 6th month
physical activity variables-4
Healthy Lifestyle Behaviors Scale Nutrition subscale score of students participating in health promotion model based health promotion program will be higher than pre-program and non-program group.
Measured: start, 1st, 3rd, 6th month
cognitive variables
Self-efficacy Scale for Regulation of Nutritional Habits of students participating in health promotion model-based health promotion program will be higher than pre-program and non-program group.
Measured: start, 1st, 3rd, 6th month
cognitive variables-2
Self-efficacy Scale for Regular Exercise Scale of students participating in health promotion model-based health promotion program will be higher than pre-program and non-program group.
Measured: start, 1st, 3rd, 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start1 Jan 2019
- Primary completion1 Sep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayşe Dost, Lecturer, Principal investigator, Medipol UniversityMelek Nihal Esin, Professor, Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195516
- Sponsor's protocol ID
- aysedost
- Status last verified
- Aug 2019
- First submitted
- 20 Aug 2019
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: publish in international journals write a chapter in this field
Publications
Napolitano MA, Whiteley JA, Mavredes MN, Faro J, DiPietro L, Hayman LL, Neighbors CJ, Simmens S. Using social media to deliver weight loss programming to young adults: Design and rationale for the Healthy Body Healthy U (HBHU) trial. Contemp Clin Trials. 2017 Sep;60:1-13. doi: 10.1016/j.cct.2017.06.007. Epub 2017 Jun 10.
PubMed 28611007Patrick K, Marshall SJ, Davila EP, Kolodziejczyk JK, Fowler JH, Calfas KJ, Huang JS, Rock CL, Griswold WG, Gupta A, Merchant G, Norman GJ, Raab F, Donohue MC, Fogg BJ, Robinson TN. Design and implementation of a randomized controlled social and mobile weight loss trial for young adults (project SMART). Contemp Clin Trials. 2014 Jan;37(1):10-8. doi: 10.1016/j.cct.2013.11.001. Epub 2013 Nov 9.
PubMed 24215774
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Promotion Program Applied to University Students on Improving Healthy Nutrition and Physical Activity Behaviors
- ClinicalTrials.gov ID
- NCT04195516
- Acronym / sponsor ID
- aysedost
- Keywords
- health promotion, university students, obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 12 Dec 2019 (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.
There are many descriptive studies in the literature on health behaviors of university youth.However, there are a limited number of model-based interventional studies explaining the development of positive health behaviors of students in the university period.In this context, this study "Applied to University Students The aim of this study will be to determine the Impact of Health Promotion Program on Developing Healthy Nutrition and Physical Activity Behaviors.This study was planned as a randomized controlled experimental study to determine the effect of the health promotion program applied to university students on the development of healthy eating and physical activity behaviors. The general population of the study will be composed of students enrolled in a formal education program at Istanbul Medipol University between January and September 2019.
The study population will consist of students with a body mass index between 25-35 kg / m², a mean nutritional behavior score of 2 or less, no regular physical activity, and no musculoskeletal, cardiopulmonary, metabolic or other systemic problems that prevent exercise.The sample size was calculated by power analysis. In the calculation, 0,80 power value, 0,05 error level, 0,60 'relationship is predicted, sampling 45 students to the experiment, 45 students to the control group was found to be appropriate. Experimental and control groups will be appointed by making probable selection from the study universe. In the study process, 10 substitutes were selected considering that there could be subjects who could leave the research. After all; 55 people in the experimental group and 55 people in the control group were selected by sampling. The sample consisted of 110 students.
Detailed description
- In order to identify the risky students in the study universe, a stand will be opened in the most crowded area and the most frequently used area of the campus.
- As a result of the screening, body mass indexes are between 25-35 kg / m², nutritional behavior score is 2 or less, do not perform regular physical activity and do not have problems related to musculoskeletal system, cardiopulmonary system, metabolic system and other systems. Students will be admitted to the study universe.
- Assignment will be made to the experimental and control groups by making probable selection from the study population.
- Measurements of physical and cognitive variables of experimental and control groups will be made.
- Health Promotion Modeled Health Promotion Program (Annex-1) will be applied to the experimental group. Health promotion program; The Web-based Health Promotion Program includes individual counseling and reminder practices. The content of the Web Based Health Promotion Program is given in Annex-2. The control group will be given educational brochures to develop healthy eating and physical activity behaviors.
- Measurements of physical and cognitive variables of experimental and control groups at 1st, 3rd and 6th months will be made.
- The data will be analyzed and evaluated statistically.
- Report will be written.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Promotion Group | Experimental | Other: web based training,individual counseling, using remindersExperimental group will be applied Health Promotion Model Basic Health Promotion Program. Health promotion program; The Web-based Health Promotion Program includes individual counseling and reminder practices. |
| Control Group | No intervention | –The control group will be given educational brochures to develop healthy eating and physical activity behaviors. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Students with body mass indexes between 25-35 kg / m² Nutritional behavior of students with a mean score of 2 and below Students who do not do regular physical activity
Key exclusion criteria (1 listed)
- Students who have problems with musculoskeletal system, cardiopulmonary system, metabolic system and other systems that will prevent exercise will not be accepted.
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 |
|---|---|---|
| web based training,individual counseling, using remindersHealth Promotion Model based Health Promotion Program will be applied to the experimental group. Health promotion program; The Web-based Health Promotion Program includes individual counseling and reminder practices. Within the context of the Web Based Health Promotion Program, 8 weeks of training to improve healthy eating and physical activity behaviors, individual counseling will be given. Colorful picture reminders will be sent to the experimental group through Whatsapp groups. At the end of the intervention, cognitive and physical measurements of the students will be done at 1st, 3rd and 6th months. | Other | Health Promotion Group |
Primary outcome
physical activity variables
Time frame: start, 1st, 3rd, 6th month
Post-intervention BMI and weight average of students participating in health promotion model based health promotion program will be lower than pre-program and non-program group.
8 secondary outcomes
nutrition behaviors variables
Time frame: start, 1st, 3rd, 6th month
nutrition behaviors variables-2
Time frame: start, 1st, 3rd, 6th month
physical activity variables-2
Time frame: start, 1st, 3rd, 6th month
nutrition behaviors variables-3
Time frame: start, 1st, 3rd, 6th month
physical activity variables-3
Time frame: start, 1st, 3rd, 6th month
physical activity variables-4
Time frame: start, 1st, 3rd, 6th month
cognitive variables
Time frame: start, 1st, 3rd, 6th month
cognitive variables-2
Time frame: start, 1st, 3rd, 6th month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Background: PubMed 28611007Napolitano MA, Whiteley JA, Mavredes MN, Faro J, DiPietro L, Hayman LL, Neighbors CJ, Simmens S. Using social media to deliver weight loss programming to young adults: Design and rationale for the Healthy Body Healthy U (HBHU) trial. Contemp Clin Trials. 2017 Sep;60:1-13. doi: 10.1016/j.cct.2017.06.007. Epub 2017 Jun 10.
- Background: PubMed 24215774Patrick K, Marshall SJ, Davila EP, Kolodziejczyk JK, Fowler JH, Calfas KJ, Huang JS, Rock CL, Griswold WG, Gupta A, Merchant G, Norman GJ, Raab F, Donohue MC, Fogg BJ, Robinson TN. Design and implementation of a randomized controlled social and mobile weight loss trial for young adults (project SMART). Contemp Clin Trials. 2014 Jan;37(1):10-8. doi: 10.1016/j.cct.2013.11.001. Epub 2013 Nov 9.
- Individual participant dataSharing planned: Yes. publish in international journals write a chapter in this field
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Ayşe Dost, Lecturer principal investigator
Medipol University
Melek Nihal Esin, Professor study director
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing web based training,individual counseling, using reminders in people with Obesity and Students, run by Istanbul Medipol University Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Dec 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Dost, Lecturer (+90507 650 62 38, adost@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical activity variables (time frame: start, 1st, 3rd, 6th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04195516, which also lists 2 linked publications.
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 12 Dec 2019.