NCT02999425

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,822

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

2.2 years

First QC Date

December 15, 2016

Last Update Submit

January 29, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Knowledge assessed on the Health-Promoting Lifestyle Profile

    Change from Baseline Knowledge at 3 months

Secondary Outcomes (1)

  • Health-Related Quality of Life assessed on the Short-Form Health Survey

    Change from Baseline Health-Related Quality of Life at 3 months

Study Arms (1)

Education

EXPERIMENTAL

Educational intervention to study participants

Other: Education

Interventions

Educational intervention

Education

Eligibility Criteria

Age10 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • General population older than 10 years

You may not qualify if:

  • Clinical patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Health, Exercise and Sport Sciences

Belgrade, 11000, Serbia

Location

Related Publications (3)

  • 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.

    PMID: 25256185BACKGROUND
  • 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.

    PMID: 24592967BACKGROUND
  • 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.

    PMID: 24380796BACKGROUND

MeSH Terms

Conditions

Behavior

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Sergej M Ostojic, MD, PhD

    Center for Health, Exercise and Sport Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2016

First Posted

December 21, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 30, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

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

Locations