Activation of Young Men - Population-Based Randomised Controlled Trial

Obesity Clinical Trial

— MOPO  

Official title:

Activation of Young Men - Population-Based Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01376986
• Other study ID #: OKM/98/627/2010
• Status: Completed
• Phase: N/A
• First received: June 16, 2011
• Last updated: June 26, 2014
• Start date: September 2013
• Est. completion date: April 2014

Study information

• Verified date: June 2014
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 507
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 17 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Obesity
• Quality of Life
• Well-being

Intervention

Behavioral:
• physical, psychological and social activation

Locations

Country	Name	City	State
Finland	University of Oulu	Oulu

Sponsors (5)

Lead Sponsor	Collaborator
University of Oulu	City of Oulu, Finnish Defence Forces, Oulu Deaconess Institute, Virpiniemi Sports Institute

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Ahola R, Pyky R, Jämsä T, Mäntysaari M, Koskimäki H, Ikäheimo TM, Huotari ML, Röning 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	physical activity	physical activity measured continuously over the 6-month trial	6 months	No
Secondary	weight		6 months	No

External Links

•   study web page