Clinical trial NCT04195516: Improving Healthy Nutrition and Physical Activity Behaviors of University Students
Official title: The Effect of Health Promotion Program Applied to University Students on Improving Healthy Nutrition and Physical Activity Behaviors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Students
Keywords: health promotion
university students
obesity
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: physical activity variables
timeFrame: start, 1st, 3rd, 6th month
Secondary outcomes:
measure: nutrition behaviors variables
timeFrame: start, 1st, 3rd, 6th month
measure: nutrition behaviors variables-2
timeFrame: start, 1st, 3rd, 6th month
measure: physical activity variables-2
timeFrame: start, 1st, 3rd, 6th month
measure: nutrition behaviors variables-3
timeFrame: start, 1st, 3rd, 6th month
measure: physical activity variables-3
timeFrame: start, 1st, 3rd, 6th month
measure: physical activity variables-4
timeFrame: start, 1st, 3rd, 6th month
measure: cognitive variables
timeFrame: start, 1st, 3rd, 6th month
measure: cognitive variables-2
timeFrame: start, 1st, 3rd, 6th month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Medipol Üniversitesi
Study officials:
affiliation: Medipol University
name: Ayşe Dost, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University
name: Melek Nihal Esin, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
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.