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

NCT ID: NCT02999425

Last Updated: 2019-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3822 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Education

Educational intervention to study participants

Group Type EXPERIMENTAL

Education

Intervention Type OTHER

Educational intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Education

Educational intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* General population older than 10 years

Exclusion Criteria

* Clinical patients
Minimum Eligible Age

10 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Center for Health Sciences, Serbia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sergej M Ostojic, MD, PhD

Role: STUDY_CHAIR

Center for Health, Exercise and Sport Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center for Health, Exercise and Sport Sciences

Belgrade, , Serbia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Serbia

References

Explore related publications, articles, or registry entries linked to this study.

Holt AM, Jancey J, Lee AH, Kerr DA, Hills AP, Anderson AS, Howat PA. A cluster-randomised controlled trial of a physical activity and nutrition programme in retirement villages: a study protocol. BMJ Open. 2014 Sep 25;4(9):e005107. doi: 10.1136/bmjopen-2014-005107.

Reference Type BACKGROUND
PMID: 25256185 (View on PubMed)

Gillison F, Standage M, Verplanken B. A cluster randomised controlled trial of an intervention to promote healthy lifestyle habits to school leavers: study rationale, design, and methods. BMC Public Health. 2014 Mar 4;14:221. doi: 10.1186/1471-2458-14-221.

Reference Type BACKGROUND
PMID: 24592967 (View on PubMed)

Morgan PJ, Collins CE, Plotnikoff RC, Callister R, Burrows T, Fletcher R, Okely AD, Young MD, Miller A, Lloyd AB, Cook AT, Cruickshank J, Saunders KL, Lubans DR. The 'Healthy Dads, Healthy Kids' community randomized controlled trial: a community-based healthy lifestyle program for fathers and their children. Prev Med. 2014 Apr;61:90-9. doi: 10.1016/j.ypmed.2013.12.019. Epub 2013 Dec 29.

Reference Type BACKGROUND
PMID: 24380796 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ASA-1617

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Make Better Choices Study
NCT00113672 COMPLETED NA
PE Audit and Feedback Pilot Study
NCT05509803 COMPLETED NA