Effectiveness of Targeted Educational Intervention on Healthy Lifestyle Behaviors in Serbian Population

Effectiveness of Targeted Educational Intervention on Healthy Lifestyle Behaviors in Serbian Population: Make Right Choices Fro Lifelong Health

The overall idea to be evaluated in this project is that educational activities providing top-notch knowledge on diet and physical activity may represent an additional benefit to the strategies aimed at decreasing lifestyle diseases in Serbian population of both young and mature age. The specific objectives of this project are:

  1. to develop user-friendly guidelines for physical activity and nutrition for two age group cohorts (K-12 and adults) of Serbia residents;
  2. to provide a brief educational intervention about nutrition and healthy lifestyles at school or work settings in each age group;
  3. to determine if an educational intervention would yield an additional benefit in the acquisition of knowledge on nutrition and physical activity;
  4. to promote and disseminate project results using popular media, non-professional and professional bodies and relevant events.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the first stage of the project, investigators will recruit national experts from academia and governmental bodies to develop distinctive user-friendly guidelines on nutrition and physical activity based on gold-standard recommendations currently available, from the US Centers for Disease Control and Prevention, World Health Organization, American College of Sports Medicine and American Heart Association. Intended for general public, two laymen guidelines will be produced, each for a specific age group (K-12 and adults), with both documents outline how people can improve their overall eating patterns and how children and adults can improve their health through physical activity. For the second stage, ~ 2.000 participants (a nationally representative sample of K-12 and adult age group) will participate in a tailored educational intervention delivered by CHESS experts (health professional and physical education teachers), with a summary of above layman reports delivered to recruited participants via 50 oral sessions. Both groups will complete pre- and post-intervention questionnaires of the Health-Promoting Lifestyle Profile (HPLS) and Short-Form Health Survey, standard easy-to-administer questionnaires that measure health-promoting lifestyle knowledge in different scales. In the third phase, investigators will compare the effectiveness of targeted health-promoting education, comparing pre-intervention vs. post-intervention (at 3 months) HPLS total scores. Collected data will be organized in nationally recognized Open Access database, with descriptive information on all relevant outcomes presented in user-friendly electronic format for whole sample and each age-specific sub-population. Finally, both guidelines on nutrition and physical activity, and the outcomes on educational intervention to promote healthy lifestyles among K-12 and adult population will be further disseminated:

  1. to general public through media, conferences and Layman's report;
  2. to interested and relevant stakeholders in the field of health, education and sport through overview in brief memorandum; and
  3. to professional bodies and groups through interactive meetings and workshops.

Finally, the results will be further disseminated at relevant conferences, e-media and journal papers.

Study Type

Interventional

Enrollment (Actual)

3822

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Belgrade, Serbia, 11000
        • Center for Health, Exercise and Sport Sciences

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

Ages Eligible for Study

10 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • General population older than 10 years

Exclusion Criteria:

  • Clinical patients

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Education
Educational intervention to study participants
Educational intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knowledge assessed on the Health-Promoting Lifestyle Profile
Time Frame: Change from Baseline Knowledge at 3 months
Change from Baseline Knowledge at 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Health-Related Quality of Life assessed on the Short-Form Health Survey
Time Frame: Change from Baseline Health-Related Quality of Life at 3 months
Change from Baseline Health-Related Quality of Life at 3 months

Collaborators and Investigators

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

Investigators

  • Study Chair: Sergej M Ostojic, MD, PhD, Center for Health, Exercise and Sport Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

October 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

December 15, 2016

First Submitted That Met QC Criteria

December 20, 2016

First Posted (Estimate)

December 21, 2016

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • ASA-1617

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Assessed outcomes will be shared via open database when study finished, via direct contact with PI

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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