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Improving Healthy Nutrition and Physical Activity Behaviors of University Students

Primary Purpose

Obesity, Students

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
web based training,individual counseling, using reminders
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring health promotion, university students, obesity

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • İstanbul Medipol ÜniversitesiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Health Promotion Group

Control Group

Arm Description

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.

The control group will be given educational brochures to develop healthy eating and physical activity behaviors.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 20, 2019
Last Updated
December 9, 2019
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04195516
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Students
Keywords
health promotion, university students, obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Health Promotion Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will be given educational brochures to develop healthy eating and physical activity behaviors.
Intervention Type
Other
Intervention Name(s)
web based training,individual counseling, using reminders
Intervention Description
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.
Primary Outcome Measure Information:
Title
physical activity variables
Description
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.
Time Frame
start, 1st, 3rd, 6th month
Secondary Outcome Measure Information:
Title
nutrition behaviors variables
Description
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.
Time Frame
start, 1st, 3rd, 6th month
Title
nutrition behaviors variables-2
Description
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.
Time Frame
start, 1st, 3rd, 6th month
Title
physical activity variables-2
Description
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.
Time Frame
start, 1st, 3rd, 6th month
Title
nutrition behaviors variables-3
Description
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.
Time Frame
start, 1st, 3rd, 6th month
Title
physical activity variables-3
Description
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.
Time Frame
start, 1st, 3rd, 6th month
Title
physical activity variables-4
Description
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.
Time Frame
start, 1st, 3rd, 6th month
Title
cognitive variables
Description
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.
Time Frame
start, 1st, 3rd, 6th month
Title
cognitive variables-2
Description
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.
Time Frame
start, 1st, 3rd, 6th month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayşe Dost, Lecturer
Phone
+90507 650 62 38
Email
adost@medipol.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayşe Dost, Lecturer
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Melek Nihal Esin, Professor
Organizational Affiliation
Istanbul University
Official's Role
Study Director
Facility Information:
Facility Name
İstanbul Medipol Üniversitesi
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayşe Dost, Lecturer
Phone
5076506238
Email
adost@medipol.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
publish in international journals write a chapter in this field
IPD Sharing Time Frame
after June 2020
IPD Sharing Access Criteria
all person
Citations:
PubMed Identifier
28611007
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.
Results Reference
background
PubMed Identifier
24215774
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.
Results Reference
background

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Improving Healthy Nutrition and Physical Activity Behaviors of University Students

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