ObesityMOPONCT01376986
Activation of Young Men - Population-Based Randomised Controlled Trial
A study testing physical, psychological and social activation in people with Obesity and Well-being, run by University of Oulu at 1 site in Finland.
Trial summary
The aim of the study is to investigate different novel IC technologies for promoting physical activity and health and preventing obesity in young men. The purpose is to provide new evidence-based knowledge on the effectiveness of an ICT-based physical activation and to identify factors predicting a positive response. Read more about this study
- Who is it for?
- Ages 17 to 18 years, men only
- Conditions the study is for
- Obesity, Well-being, Quality of Life
- What is being tested?
- physical, psychological and social activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 507 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2013to Apr 2014
- 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 17 to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- All men born 1995 liable for military service and attending call-ups in Oulu area at 2013
Who cannot join
- Severe physical or mental illness
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to investigate different novel IC technologies for promoting physical activity and health and preventing obesity in young men. The purpose is to provide new evidence-based knowledge on the effectiveness of an ICT-based physical activation and to identify factors predicting a positive response.
Specific objectives
Read more
- to identify the factors associated with physical activity and physical activity relationship in young men
- to develop an interactive method, based on peer networks, aimed at activating young men with use of their own skills, participation and modern ICT
- to assess the effectiveness of the chosen activation on the physical activity, weight, fitness, health, and relationship towards physical activity among young men
The study population consists of all conscription aged men in the Oulu area in 2011-2013 (n=4000). Conscription-aged men provide a large, population based representative sample of young men. In Finland military service is mandatory and annually all 18-year old men are called for military service. In the call-ups fitness for service is determined based on medical examination.
All those who are determined fit for service or who are granted postponement due to obesity will be invited for the activation intervention study. Those with severe obesity are exempted from service, but will also participate in the trial. After the call-up, the men will be randomised to an intervention group and a control group. The primary outcome variable is change in physical activity.
The study will be conducted during 2011-2015. The study includes technology development (ICT platform), collection of cross-sectional data at the call-ups, and a 6-month physical activity intervention (a randomized controlled trial) implemented between the call-up and start of military service. Game mechanics are integrated into the ICT platform to increase user engagement and participation.
Physical activity, fitness (aerobic and muscular), body composition,lifestyle and psychological and physical health will be followed. In addition, the subjects' entry into military service and its course will be followed.
- Conditions
- Obesity, Well-being, Quality of Life, Depression
- Being tested
- physical, psychological and social activation
- Medical subject headings
- Obesity, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical, psychological and social activationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Activation | Experimental | All those determined fit for service or who are granted postponement will be included in the activation intervention. The physical activation intervention will be implemented between the call-up and start of military service. The activation group utilises an ICT platform that will be developed. Receives: Behavioral: physical, psychological and social activation |
| control | No intervention | no access to the activation platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activity
physical activity measured continuously over the 6-month trial
Measured: 6 months
Secondary outcomes (1)
weight
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startSep 2013
- Primary completionMar 2014
- Study completionApr 2014
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 ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 507 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu Deaconess Institute, City of Oulu, Finnish Defense Forces, Virpiniemi Sports Institute
- Responsible party
- Principal investigator, Raija Korpelainen, University of Oulu
- Investigators
- Timo Jämsä, PhD, Study director, University of OuluMatti Mäntysaari, MD, Study director, Finnish Defense ForcesRaija Korpelainen, PhD, Study director, raija.korpelainen@odl.fi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376986
- Sponsor's protocol ID
- OKM/98/627/2010
- Acronym
- MOPO
- Status last verified
- Jun 2014
- First submitted
- 16 Jun 2011
- Last updated
- 27 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ahola R, Pyky R, Jamsa T, Mantysaari M, Koskimaki H, Ikaheimo TM, Huotari ML, Roning J, Heikkinen HI, Korpelainen R. Gamified physical activation of young men--a Multidisciplinary Population-Based Randomized Controlled Trial (MOPO study). BMC Public Health. 2013 Jan 14;13:32. doi: 10.1186/1471-2458-13-32.
PubMed 23311678Leinonen AM, Pyky R, Ahola R, Kangas M, Siirtola P, Luoto T, Enwald H, Ikaheimo TM, Roning J, Keinanen-Kiukaanniemi S, Mantysaari M, Korpelainen R, Jamsa T. Feasibility of Gamified Mobile Service Aimed at Physical Activation in Young Men: Population-Based Randomized Controlled Study (MOPO). JMIR Mhealth Uhealth. 2017 Oct 10;5(10):e146. doi: 10.2196/mhealth.6675.
PubMed 29017991Jauho AM, Pyky R, Ahola R, Kangas M, Virtanen P, Korpelainen R, Jamsa T. Effect of wrist-worn activity monitor feedback on physical activity behavior: A randomized controlled trial in Finnish young men. Prev Med Rep. 2015 Jul 22;2:628-34. doi: 10.1016/j.pmedr.2015.07.005. eCollection 2015.
PubMed 26844128
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activation of Young Men - Population-Based Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01376986
- Acronym / sponsor ID
- MOPO / OKM/98/627/2010
- Conditions
- Obesity, Well-being, Quality of Life, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 507 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Oulu Deaconess Institute, City of Oulu, Finnish Defense Forces, Virpiniemi Sports Institute
- Study start
- Sep 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 20 Jun 2011 (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 aim of the study is to investigate different novel IC technologies for promoting physical activity and health and preventing obesity in young men. The purpose is to provide new evidence-based knowledge on the effectiveness of an ICT-based physical activation and to identify factors predicting a positive response.
Specific objectives
- to identify the factors associated with physical activity and physical activity relationship in young men
- to develop an interactive method, based on peer networks, aimed at activating young men with use of their own skills, participation and modern ICT
- to assess the effectiveness of the chosen activation on the physical activity, weight, fitness, health, and relationship towards physical activity among young men
The study population consists of all conscription aged men in the Oulu area in 2011-2013 (n=4000). Conscription-aged men provide a large, population based representative sample of young men. In Finland military service is mandatory and annually all 18-year old men are called for military service. In the call-ups fitness for service is determined based on medical examination.
All those who are determined fit for service or who are granted postponement due to obesity will be invited for the activation intervention study. Those with severe obesity are exempted from service, but will also participate in the trial. After the call-up, the men will be randomised to an intervention group and a control group. The primary outcome variable is change in physical activity.
The study will be conducted during 2011-2015. The study includes technology development (ICT platform), collection of cross-sectional data at the call-ups, and a 6-month physical activity intervention (a randomized controlled trial) implemented between the call-up and start of military service. Game mechanics are integrated into the ICT platform to increase user engagement and participation.
Physical activity, fitness (aerobic and muscular), body composition,lifestyle and psychological and physical health will be followed. In addition, the subjects' entry into military service and its course will be followed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activation | Experimental | Behavioral: physical, psychological and social activationAll those determined fit for service or who are granted postponement will be included in the activation intervention. The physical activation intervention will be implemented between the call-up and start of military service. The activation group utilises an ICT platform that will be developed. |
| control | No intervention | –no access to the activation platform |
Who may qualify
- Ages
- 17 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All men born 1995 liable for military service and attending call-ups in Oulu area at 2013
Key exclusion criteria (1 listed)
- Severe physical or mental illness
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 |
|---|---|---|
| physical, psychological and social activation | Behavioural | Activation |
Primary outcome
physical activity
Time frame: 6 months
physical activity measured continuously over the 6-month trial
1 secondary outcome
weight
Time frame: 6 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 27 Jun 2014.
- Background: PubMed 23311678Ahola R, Pyky R, Jamsa T, Mantysaari M, Koskimaki H, Ikaheimo TM, Huotari ML, Roning J, Heikkinen HI, Korpelainen R. Gamified physical activation of young men--a Multidisciplinary Population-Based Randomized Controlled Trial (MOPO study). BMC Public Health. 2013 Jan 14;13:32. doi: 10.1186/1471-2458-13-32.
- Derived from this study: PubMed 29017991Leinonen AM, Pyky R, Ahola R, Kangas M, Siirtola P, Luoto T, Enwald H, Ikaheimo TM, Roning J, Keinanen-Kiukaanniemi S, Mantysaari M, Korpelainen R, Jamsa T. Feasibility of Gamified Mobile Service Aimed at Physical Activation in Young Men: Population-Based Randomized Controlled Study (MOPO). JMIR Mhealth Uhealth. 2017 Oct 10;5(10):e146. doi: 10.2196/mhealth.6675.
- Derived from this study: PubMed 26844128Jauho AM, Pyky R, Ahola R, Kangas M, Virtanen P, Korpelainen R, Jamsa T. Effect of wrist-worn activity monitor feedback on physical activity behavior: A randomized controlled trial in Finnish young men. Prev Med Rep. 2015 Jul 22;2:628-34. doi: 10.1016/j.pmedr.2015.07.005. eCollection 2015.
Related trials for Obesity
Recruiting
Preserving Muscle Mass During Incretin-Induced Weight Loss
Obesity (BMI > 35)
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Synchronous vs Asynchronous Remotely Delivered Lifestyle Interventions
Obesity
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.
Timo Jämsä, PhD study director
University of Oulu
Matti Mäntysaari, MD study director
Finnish Defense Forces
Raija Korpelainen, PhD study director
raija.korpelainen@odl.fi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical, psychological and social activation in people with Obesity and Well-being, run by University of Oulu at 1 site in Finland.
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 27 Jun 2014. 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 Finland. 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?
physical activity (time frame: 6 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 NCT01376986, 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 27 Jun 2014.