NCT05301166

Brief Summary

The aim of this study is to determine the effects of technology-based motivation education prepared according to the health belief model on obesity-related beliefs and attitudes, nutrition-exercise behaviors, self-efficacy and weight management in obese university students.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

March 19, 2022

Last Update Submit

March 19, 2022

Conditions

Keywords

ObesityMotivational InterviewingHealth Belief ModelNursing

Outcome Measures

Primary Outcomes (3)

  • Obesity Health Belief Model Scale

    The scale assesses individuals' beliefs and attitudes towards weight loss. It consists of 32 items in total. The scale has five sub-dimensions that can be used independently of each other: importance of health, sensitivity, seriousness, perception of benefit and disability. The cronbach alpha coefficient of the scale is 0.80.

    4 Months

  • Nutrition-Exercise Behavior Scale

    The scale was developed to identify feeding-related behaviors. It consists of 45 items. The scale has four sub-dimensions: psychological (addicted) eating behavior, healthy diet-exercise behavior, unhealthy diet-exercise behavior, and meal order. The Cronbach Alpha reliability coefficient of the scale is 0.85.

    4 Months

  • Self-Effectiveness-Efficacy Scale

    The scale measures the perception of general self-efficacy-effectiveness that is not specific to any field. The scale consists of 23 items. The scale has four sub-dimensions: initiating the behavior, maintaining the behavior, completing the behavior and struggling with obstacles. The cronbach alpha coefficient of the Turkish version of the scale is 0.81.

    4 Months

Study Arms (2)

Interventional Group

EXPERIMENTAL

The intervention group of the RCT consisted of 42 randomly selected students with a Body Mass Index (BMI) score of 25 and above, who were evaluated by inclusion and exclusion criteria. Students in the intervention group will participate in the Technology-Based Motivation Education Program. This program will last 4 months. * Students in the intervention group will conduct semi-structured individual motivational interviews, consisting of 6 sessions in total, prepared according to the components of the Health Belief Model. * Students in the intervention group will access the web-based education and motivation program that supports motivational interviews by logging into the website prepared for the study.

Behavioral: Technology Based Motivation Education Program

Control Group

OTHER

The intervention group of the RCT consisted of 42 randomly selected students with a Body Mass Index (BMI) score of 25 and above, who were evaluated by inclusion and exclusion criteria. * Students in the control group will only participate in the web-based education of the Technology-Based Motivation Education Program prepared according to the Health Belief Model for obesity. * Students in the control group will be given face-to-face or online interviews once a month for 4 months, lasting 10-15 minutes, in accordance with the web-based education content.

Other: Web Based Education

Interventions

Technology-Based Motivation Education Program consists of web-based education, motivation program and individual motivation interviews. This program will be prepared according to the Health Belief Model (HBM). It will be applied for 4 months. Participants will take a pre-test before starting the program and a post-test at the end of the program. Individual motivation interviews will be 6 sessions in total. A website will be prepared for the Technology Based Motivation Education Program. This website consists of two parts, a web-based education and motivation program for obesity. The motivation program will enable the participant to follow the program and receive motivational messages.

Interventional Group

Students in the control group will participate in web-based educations on obesity prepared only according to the Health Belief Model in the Technology-Based Motivation Education Program. Individual interviews supporting web-based education will be held with the control group once a month.

Control Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age range
  • Body Mass Index (BMI) ≥ 25.0,
  • Having internet access with a computer, tablet or mobile device.

You may not qualify if:

  • Under 18 years old or over 25 years old,
  • BMI \< 25.0,
  • Continuously using regular medication,
  • Presence of a pre-existing health problem (having a surgical operation in the last three months, having diseases with metabolic syndrome, being diagnosed with cancer, being diagnosed with an eating disorder, being diagnosed with a psychological illness, and being physically disabled),
  • Participating in any weight management program in the last three months,
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas Cumhuriyet University

Sivas, 58000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Nuran GÜLER, Prof. Dr.

    Cumhuriyet University

    STUDY DIRECTOR

Central Study Contacts

Muhammed Akif Sami TOKER, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
In the randomized controlled study, blinding will be done in terms of statistician and reporting. The data regarding the pre-test and post-tests will be collected by another researcher who does not know who is in the experimental and control group, and the research data will be coded and transferred to the computer environment by another researcher without specifying the experimental and control groups. The analysis of the data coded in terms of groups will be done by a statistics expert. After the statistical analyzes are made and the research report is written, the assistant researcher will explain the coding for the experimental and control groups. In this way, a single blinding application was planned for the researcher.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Quasi-experimental pretest-posttest randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 19, 2022

First Posted

March 29, 2022

Study Start

February 1, 2022

Primary Completion

July 15, 2022

Study Completion

June 30, 2023

Last Updated

March 29, 2022

Record last verified: 2022-03

Locations