NCT05482659

Brief Summary

Aim: In this study, it was aimed to determine the effect of health education given to overweight university students based on the Transtheoretic Model (TTM) on nutrition and physical activity behaviors. Materials and Methods: The research was conducted in a randomized controlled experimental design. The sample of the study consisted of 54 students, 27 of which were in the experimental group and 27 in the control group, who met the inclusion criteria between October 2021 and November 2021. Students were divided into nutrition and exercise change stages groups according to TTM. The students in the experimental group were given one-on-one health education in accordance with the TTM change stages, using the online method. In the study, data were collected using the Sociodemographic Form, Nutrition and Exercise Stage Determination Form according to TTM, Nutrition Change Processes Scale (NCPS) and Exercise Change Processes Scale (ECPS). Chi-square test and t test for dependent and independent groups were used in the analysis of the data obtained. Statistical significance level was accepted as p\<0.05.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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 25, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

5 months

First QC Date

July 28, 2022

Last Update Submit

July 29, 2022

Conditions

Keywords

transtheoretical modelPublic Health NursingUniversity Student

Outcome Measures

Primary Outcomes (1)

  • Stages of change according to the transtheoretic model - pre-intervention and post-intervention

    The stages of change of the transtheoretic model were measured before and after the intervention to determine that university students changed their unhealthy diet and insufficient physical activity behaviors.

    4 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Health education on healthy nutrition and regular physical activity based on the transtheoretic model was given to overweight university students in the experimental group once a week (every 4 weeks) using the online education method.

Behavioral: Health education on healthy nutrition and regular physical activity based on the transtheoretic model

control group

NO INTERVENTION

No attempt was made to the students in the control group during the intervention process. When the intervention process of the experimental group was finished, the materials used in health education were shared with the students.

Interventions

An announcement was made by visiting all the faculties at Nuh Naci Yazgan University, stating the content of the research and the duration of the research. Among the volunteer students, students who met the inclusion criteria were included in the study. Afterwards, the students were assigned to the groups by the statistician using a simple randomization method. As a result of the pre-test, it was determined which change stage each student was in according to the Transtheoretic model (TTM). The students were not given information about which group they were in and what stage they were in according to TTM. Health education was given to university students once a week by online education method and it took 4 weeks-30 days to complete the research. The average duration of the health education given to each student is 30-45 minutes. When the training process was over, the post-test questions were sent to the students by the online survey method.

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Agreeing to participate in the research,
  • University students without chronic diseases
  • BMI level between 24.9 and 30,
  • Open to communication and cooperation,
  • Internet and smartphone/tablet/computer etc. owner.

You may not qualify if:

  • BMI level of 24.9 and below,
  • Using any drug,
  • Who left the research voluntarily.
  • Under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuh Naci Yazgan University

Kayseri, Küme Evler Mahallesi, 38170, Turkey (Türkiye)

Location

Study Officials

  • Cansu Yaşar, 1

    cyasar@nny.edu.tr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

July 28, 2022

First Posted

August 1, 2022

Study Start

June 25, 2021

Primary Completion

November 30, 2021

Study Completion

February 25, 2022

Last Updated

August 1, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations