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Obesity Intervention Program for University Students

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03115229
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Tuba Demirel, Selcuk University

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Protective Nursing Interventions for Reduction Obesity Risk Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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

Primary Purpose: Prevention
Official Title: The Effects of Protectıve Nursing Interventions on Reduction of Obesity Risk In University Students: Randomized Controlled Study
Actual Study Start Date : June 10, 2015
Actual Primary Completion Date : March 7, 2016
Actual Study Completion Date : May 27, 2016

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
Behavioral: 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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Bady Mass Index [ Time Frame: Totaly: 11 weeks ]
    Weight/Height Ratio

  2. Waist / Hip [ Time Frame: Totaly: 11 weeks ]
    Waist / Hip Ratio

  3. Body fat percentage [ Time Frame: Totaly: 11 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 24 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115229


Sponsors and Collaborators
Selcuk University
Investigators
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Study Director: Belgin Akın, Professor Selcuk University
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Responsible Party: Tuba Demirel, Selçuk University Coordinator of Scientific Research Projects, Selcuk University
ClinicalTrials.gov Identifier: NCT03115229    
Other Study ID Numbers: 15102038
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tuba Demirel, Selcuk University:
Obesity
Overweight
Physical Activity
Nutrition
Nursing
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms