- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03115229
Obesity Intervention Program for University Students
The Effects of Protectıve Nursing Interventions on Reduction of Obesity Risk In University Students: Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
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.
|
|
Experimental: Intervention Group
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
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nutrition-Exercise Attitude Score, Nutrition-Exercise Behavior Score, Exercise Benefit / Obstacle Score
Time Frame: Totaly: 11 weeks
|
The Scale of Nutrition-Exercise Attitude-Behavior, The Scale of Exercise Benefit / Obstacle
|
Totaly: 11 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bady Mass Index
Time Frame: Totaly: 11 weeks
|
Weight/Height Ratio
|
Totaly: 11 weeks
|
Waist / Hip
Time Frame: Totaly: 11 weeks
|
Waist / Hip Ratio
|
Totaly: 11 weeks
|
Body fat percentage
Time Frame: Totaly: 11 weeks
|
Totaly: 11 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Belgin Akın, Professor, Selcuk University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15102038
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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