NCT03115229

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
Last Updated

August 28, 2019

Status Verified

March 1, 2017

Enrollment Period

9 months

First QC Date

March 22, 2017

Last Update Submit

August 23, 2019

Conditions

Keywords

ObesityOverweightPhysical ActivityNutritionNursing

Outcome Measures

Primary Outcomes (1)

  • 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

    Totaly: 11 weeks

Secondary Outcomes (3)

  • Bady Mass Index

    Totaly: 11 weeks

  • Waist / Hip

    Totaly: 11 weeks

  • Body fat percentage

    Totaly: 11 weeks

Study Arms (2)

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

Behavioral: Protective Nursing Interventions for Reduction Obesity Risk

Interventions

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.

Intervention Group

Eligibility Criteria

Age19 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityOverweightMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Belgin Akın, Professor

    Selcuk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Selçuk University Coordinator of Scientific Research Projects

Study Record Dates

First Submitted

March 22, 2017

First Posted

April 14, 2017

Study Start

June 10, 2015

Primary Completion

March 7, 2016

Study Completion

May 27, 2016

Last Updated

August 28, 2019

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share