ObesityNCT03115229
Obesity Intervention Program for University Students
A study testing Protective Nursing Interventions for Reduction Obesity Risk in people with Obesity, run by Selcuk University.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 24 years
- Conditions the study is for
- Obesity
- What is being tested?
- Protective Nursing Interventions for Reduction Obesity Risk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2015to 27 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Protective Nursing Interventions for Reduction Obesity Risk
- Keywords
- Obesity, Overweight, Physical Activity, Nutrition, Nursing
- Medical subject headings
- Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protective Nursing Interventions for Reduction Obesity RiskBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | 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. |
| Intervention Group | Experimental | 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 Receives: Behavioral: Protective Nursing Interventions for Reduction Obesity Risk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Totaly: 11 weeks
Secondary outcomes (3)
Bady Mass Index
Weight/Height Ratio
Measured: Totaly: 11 weeks
Waist / Hip
Waist / Hip Ratio
Measured: Totaly: 11 weeks
Body fat percentage
Measured: Totaly: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start10 Jun 2015
- Primary completion7 Mar 2016
- Study completion27 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Demirel, Selcuk University
- Investigators
- Belgin Akın, Professor, Study director, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115229
- Sponsor's protocol ID
- 15102038
- Status last verified
- Mar 2017
- First submitted
- 22 Mar 2017
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Protectıve Nursing Interventions on Reduction of Obesity Risk In University Students: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03115229
- Acronym / sponsor ID
- 15102038
- Conditions
- Obesity
- Keywords
- Obesity, Overweight, Physical Activity, Nutrition, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 10 Jun 2015 (actual)
- Primary completion
- 7 Mar 2016 (actual)
- Study completion
- 27 May 2016 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –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. |
| Intervention Group | Experimental | Behavioral: Protective Nursing Interventions for Reduction Obesity RiskThe 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 |
Who may qualify
- Ages
- 19 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protective Nursing Interventions for Reduction Obesity RiskApplications 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. | Behavioural | Intervention Group |
Primary outcome
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
3 secondary outcomes
Bady Mass Index
Time frame: Totaly: 11 weeks
Waist / Hip
Time frame: Totaly: 11 weeks
Body fat percentage
Time frame: Totaly: 11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Recruiting
Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change
Overweight, Obesity
RecruitingPhase 1
Evaluate the Safety and Tolerability of Multiple Doses of JMT206 Injection in Obese Participants
Valid MeSH Conditiongs
Not yet recruiting
Prospective Evaluation of Recombinant Pbserum Plus® and Pbserum HA 2.0® in Aesthetic and Regenerative Bioremodeling
Skin Laxity, Localized Adiposity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Belgin Akın, Professor study director
Selcuk University
Questions about this trial
What is this clinical trial studying?
A study testing Protective Nursing Interventions for Reduction Obesity Risk in people with Obesity, run by Selcuk University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutrition-Exercise Attitude Score, Nutrition-Exercise Behavior Score, Exercise Benefit / Obstacle Score (time frame: Totaly: 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.