BehaviorNCT02999425
Effectiveness of Targeted Educational Intervention on Healthy Lifestyle Behaviors in Serbian Population
A study testing Education in people with Behavior, run by Center for Health Sciences, Serbia at 1 site in Serbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,822 participants
- Where
- 1 siteSerbia
- Study dates
- Oct 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- General population older than 10 years
Who cannot join
- Clinical patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- to develop user-friendly guidelines for physical activity and nutrition for two age group cohorts (K-12 and adults) of Serbia residents;
- to provide a brief educational intervention about nutrition and healthy lifestyles at school or work settings in each age group;
- to determine if an educational intervention would yield an additional benefit in the acquisition of knowledge on nutrition and physical activity;
- to promote and disseminate project results using popular media, non-professional and professional bodies and relevant events.
Read the 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:
- to general public through media, conferences and Layman's report;
- to interested and relevant stakeholders in the field of health, education and sport through overview in brief memorandum; and
- 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
- Behavior
- Being tested
- Education
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Educational intervention
| Study group | Role | What they receive |
|---|---|---|
| Education | Experimental | Educational intervention to study participants Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge assessed on the Health-Promoting Lifestyle Profile
Measured: Change from Baseline Knowledge at 3 months
Secondary outcomes (1)
Health-Related Quality of Life assessed on the Short-Form Health Survey
Measured: Change from Baseline Health-Related Quality of Life at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,822 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Health Sciences, Serbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergej M Ostojic, MD, PhD, Study chair, Center for Health, Exercise and Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999425
- Sponsor's protocol ID
- ASA-1617
- Status last verified
- Jan 2019
- First submitted
- 15 Dec 2016
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Assessed outcomes will be shared via open database when study finished, via direct contact with PI
Publications
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.
PubMed 25256185Gillison 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.
PubMed 24592967Morgan 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.
PubMed 24380796
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Targeted Educational Intervention on Healthy Lifestyle Behaviors in Serbian Population: Make Right Choices Fro Lifelong Health
- ClinicalTrials.gov ID
- NCT02999425
- Acronym / sponsor ID
- ASA-1617
- Conditions
- Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,822 participants (actual)
- Lead sponsor
- Center for Health Sciences, SerbiaUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to develop user-friendly guidelines for physical activity and nutrition for two age group cohorts (K-12 and adults) of Serbia residents;
- to provide a brief educational intervention about nutrition and healthy lifestyles at school or work settings in each age group;
- to determine if an educational intervention would yield an additional benefit in the acquisition of knowledge on nutrition and physical activity;
- 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:
- to general public through media, conferences and Layman's report;
- to interested and relevant stakeholders in the field of health, education and sport through overview in brief memorandum; and
- 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Other: EducationEducational intervention to study participants |
Who may qualify
- Ages
- 10 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- General population older than 10 years
Key exclusion criteria (1 listed)
- Clinical patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationEducational intervention | Other | Education |
Primary outcome
Knowledge assessed on the Health-Promoting Lifestyle Profile
Time frame: Change from Baseline Knowledge at 3 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Background: PubMed 25256185Holt 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.
- Background: PubMed 24592967Gillison 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.
- Background: PubMed 24380796Morgan 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.
- Individual participant dataSharing planned: Yes. Assessed outcomes will be shared via open database when study finished, via direct contact with PI
Related trials for Behavior
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergej M Ostojic, MD, PhD study chair
Center for Health, Exercise and Sport Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Behavior, run by Center for Health Sciences, Serbia at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge assessed on the Health-Promoting Lifestyle Profile (time frame: Change from Baseline Knowledge at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02999425, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.