Clinical trial NCT02999425: Effectiveness of Targeted Educational Intervention on Healthy Lifestyle Behaviors in Serbian Population
Official title: Effectiveness of Targeted Educational Intervention on Healthy Lifestyle Behaviors in Serbian Population: Make Right Choices Fro Lifelong Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior
Lead sponsor: Center for Health Sciences, Serbia
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 3822
Sex: ALL
Minimum age (years): 10
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* General population older than 10 years

Exclusion Criteria:

* Clinical patients

Primary outcomes:
measure: Knowledge assessed on the Health-Promoting Lifestyle Profile
timeFrame: Change from Baseline Knowledge at 3 months
Secondary outcomes:
measure: Health-Related Quality of Life assessed on the Short-Form Health Survey
timeFrame: Change from Baseline Health-Related Quality of Life at 3 months
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Center for Health, Exercise and Sport Sciences
Study officials:
affiliation: Center for Health, Exercise and Sport Sciences
name: Sergej M Ostojic, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.