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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04195516
Other study ID # aysedost
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date December 2020

Study information

Verified date August 2019
Source Istanbul Medipol University Hospital
Contact Ayse Dost, Lecturer
Phone +90507 650 62 38
Email adost@medipol.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Description:

1. 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.

2. 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.

3. Assignment will be made to the experimental and control groups by making probable selection from the study population.

4. Measurements of physical and cognitive variables of experimental and control groups will be made.

5. 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.

6. Measurements of physical and cognitive variables of experimental and control groups at 1st, 3rd and 6th months will be made.

7. The data will be analyzed and evaluated statistically.

8. Report will be written.


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date December 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Students who have problems with musculoskeletal system, cardiopulmonary system, metabolic system and other systems that will prevent exercise will not be accepted.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
web based training,individual counseling, using reminders
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.

Locations

Country Name City State
Turkey Istanbul Medipol Üniversitesi Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

Patrick 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. start, 1st, 3rd, 6th month
Secondary 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. start, 1st, 3rd, 6th month
Secondary 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. start, 1st, 3rd, 6th month
Secondary 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. start, 1st, 3rd, 6th month
Secondary 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. start, 1st, 3rd, 6th month
Secondary 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. start, 1st, 3rd, 6th month
Secondary 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. start, 1st, 3rd, 6th month
Secondary 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. start, 1st, 3rd, 6th month
Secondary 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. start, 1st, 3rd, 6th month
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