Back to resultsObesity Intervention Program for University Students
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Protective Nursing Interventions for Reduction Obesity Risk
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Obesity, Overweight, Physical Activity, Nutrition, Nursing
Eligibility Criteria
Inclusion Criteria:
- Preobezes between 25.0-29.9 BMI
- The BMI is 18.5-24.9 and who get above the average score (24-36 points high risk) from the "Risky Behavior Scale University Form: the subscale of nutritional habits
- The BMI is 18.5-24.9 and who get below the mean score (8-20 points high risk) from the Healthy Lifestyle Behavior Scale's subscale of Exercise
Exclusion Criteria:
- BMI below 18.5 and above 29.9
- Constantly regular drug users
- Those who have any health problems (who have had a heart attack, angioplasty or any surgical operation within 3 months, those with heart failure, those with metabolic disease, those with eating disorder, those with cancer, those with any psychological disease, Physically disabled)
- Those who are pregnant
- Those who have participated in any weight management program at least 2 months in advance and are still involved in the nutrition or physical activity program
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Intervention Group
Arm Description
The control group of the RCT was composed of 35 students randomly assigned to the control group who are BMI was between 25.0-29.9 or BMI was between 18.5-24.9 and they were in the risk group in terms of obesity according to the risk rating scales.
The selected students were associated with obesity risk factors about obesity (owerveight or normal weight and they were in the risk group in terms of obesity according to the risk rating scales, and between 19-24 years old) and randomly assigned to the experimental group to Protective Nursing Interventions for Reduction Obesity Risk
Outcomes
Primary Outcome Measures
Nutrition-Exercise Attitude Score, Nutrition-Exercise Behavior Score, Exercise Benefit / Obstacle Score
The Scale of Nutrition-Exercise Attitude-Behavior, The Scale of Exercise Benefit / Obstacle
Secondary Outcome Measures
Bady Mass Index
Weight/Height Ratio
Waist / Hip
Waist / Hip Ratio
Body fat percentage
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03115229
Brief Title
Obesity Intervention Program for University Students
Official Title
The Effects of Protectıve Nursing Interventions on Reduction of Obesity Risk In University Students: Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 10, 2015 (Actual)
Primary Completion Date
March 7, 2016 (Actual)
Study Completion Date
May 27, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University
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
The aim of this study is to determine the effect of preventive nursing interventions, which consist of education / practices including of healthy eating and physical activity and motivational messages which sent through social media to reduce obesity risk in university students who in the risk group for obesity.
Detailed Description
This study has been conducted with University students in Turkey. The selected 70 students were associated with obesity risk factors about obesity (owerveight or normal weight and they were in the risk group in terms of obesity according to the risk rating scales, and between 19-24 years old) and randomly assigned to the experimental (35 students) and control group (35 students). Applications for the experimental group for 11 weeks about nutritional habits, practices for physical activity, and motivational messages sent via social media.
Primary Outcome Measure: Nutrition-Exercise Attitude Score, Nutrition-Exercise Behavior Score, Exercise Benefit / Obstacle Score. We used some scales for evaluate the primary outcomes (The Scale of Nutrition-Exercise Attitude-Behavior, The Scale of Exercise Benefit / Obstacle).
Bady Mass Index, Waist / Hip Ratio and Body fat percentage are secondary outcomes.
The data was calculated with SPSS package program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Overweight, Physical Activity, Nutrition, Nursing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
In the RCT, blindness was done in terms of data collectors and statistician. The data were collected by another investigator (assistant investigator) who did not know who was in the experiment and control group, and the data were recorded by the assistant investigator on the computer, without specifying the experiment and control group.
Experimental and control groups were coded by an assistant investigator. Analysis of the data encoded by groups was done by a statistician.
After the statistical analyzes were made and the research report was written, the assistant investigator explained the coding for the experiment and control group.
In this way, data gathering, statistical analysis and reporting have been blinded.
Note: Two assistant researchers received support from the research process. One of the assistant researcher is a coach who is a graduate of the Faculty of Sport Sciences other than Ph.D. Student of the Department of Public Health Nursing
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group of the RCT was composed of 35 students randomly assigned to the control group who are BMI was between 25.0-29.9 or BMI was between 18.5-24.9 and they were in the risk group in terms of obesity according to the risk rating scales.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The selected students were associated with obesity risk factors about obesity (owerveight or normal weight and they were in the risk group in terms of obesity according to the risk rating scales, and between 19-24 years old) and randomly assigned to the experimental group to Protective Nursing Interventions for Reduction Obesity Risk
Intervention Type
Behavioral
Intervention Name(s)
Protective Nursing Interventions for Reduction Obesity Risk
Intervention Description
Applications for the experimental group for 11 weeks are grouped under three headings.
These; Nutritional habits, practices for physical activity, and motivational messages sent via social media.
Nutritional practices: Nutritional practices consist of group trainings, individual practices and collective events.
Practices for physical activity: Group trainings, group exercises, individual exercises and collective activities. Physical activity was done for 3 days per week and 45-60 minutes every seans for 8 weeks. In addition, activities such as collective nature walks and cycling have been carried out Practices through social media: For physical activity and healthy eating; Motivational messages were sent twice a week for 11 weeks.
Primary Outcome Measure Information:
Title
Nutrition-Exercise Attitude Score, Nutrition-Exercise Behavior Score, Exercise Benefit / Obstacle Score
Description
The Scale of Nutrition-Exercise Attitude-Behavior, The Scale of Exercise Benefit / Obstacle
Time Frame
Totaly: 11 weeks
Secondary Outcome Measure Information:
Title
Bady Mass Index
Description
Weight/Height Ratio
Time Frame
Totaly: 11 weeks
Title
Waist / Hip
Description
Waist / Hip Ratio
Time Frame
Totaly: 11 weeks
Title
Body fat percentage
Time Frame
Totaly: 11 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Preobezes between 25.0-29.9 BMI
The BMI is 18.5-24.9 and who get above the average score (24-36 points high risk) from the "Risky Behavior Scale University Form: the subscale of nutritional habits
The BMI is 18.5-24.9 and who get below the mean score (8-20 points high risk) from the Healthy Lifestyle Behavior Scale's subscale of Exercise
Exclusion Criteria:
BMI below 18.5 and above 29.9
Constantly regular drug users
Those who have any health problems (who have had a heart attack, angioplasty or any surgical operation within 3 months, those with heart failure, those with metabolic disease, those with eating disorder, those with cancer, those with any psychological disease, Physically disabled)
Those who are pregnant
Those who have participated in any weight management program at least 2 months in advance and are still involved in the nutrition or physical activity program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Belgin Akın, Professor
Organizational Affiliation
Selcuk University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
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Obesity Intervention Program for University Students
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