Clinical trial NCT01376986: Activation of Young Men - Population-Based Randomised Controlled Trial
Official title: Activation of Young Men - Population-Based Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Well-being
Quality of Life
Depression
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Oulu Deaconess Institute
name: City of Oulu
name: Finnish Defense Forces
name: Virpiniemi Sports Institute
First posted: 2011-06-20
Enrollment: 507
Sex: MALE
Minimum age (years): 17
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* All men born 1995 liable for military service and attending call-ups in Oulu area at 2013

Exclusion Criteria:

* Severe physical or mental illness

Primary outcomes:
measure: physical activity
timeFrame: 6 months
Secondary outcomes:
measure: weight
timeFrame: 6 months
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: University of Oulu
Study officials:
affiliation: University of Oulu
name: Timo Jämsä, PhD
role: STUDY_DIRECTOR
affiliation: Finnish Defense Forces
name: Matti Mäntysaari, MD
role: STUDY_DIRECTOR
affiliation: raija.korpelainen@odl.fi
name: Raija Korpelainen, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Leinonen 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.
citation: Jauho 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.