Obesity Intervention Program for University Students

August 23, 2019 updated by: Tuba Demirel, Selcuk University

The Effects of Protectıve Nursing Interventions on Reduction of Obesity Risk In University Students: Randomized Controlled Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 24 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Selcuk University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Belgin Akın, Professor, Selcuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 7, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 27, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15102038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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