Activation of Young Men - Population-Based Randomised Controlled Trial (MOPO)

This study has been completed.
Sponsor:
Collaborators:
Oulu Deaconess Institute
City of Oulu
Finnish Defence Forces
Virpiniemi Sports Institute
Information provided by (Responsible Party):
Raija Korpelainen, University of Oulu
ClinicalTrials.gov Identifier:
NCT01376986
First received: June 16, 2011
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Obesity
Well-being
Quality of Life
Depression
Behavioral: physical, psychological and social activation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Activation of Young Men - Population-Based Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • physical activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    physical activity measured continuously over the 6-month trial


Secondary Outcome Measures:
  • weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 507
Study Start Date: September 2013
Study Completion Date: April 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Activation
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.
Behavioral: physical, psychological and social activation
No Intervention: control
no access to the activation platform

  Eligibility

Ages Eligible for Study:   17 Years to 18 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01376986

Locations
Finland
University of Oulu
Oulu, Finland, 90014
Sponsors and Collaborators
University of Oulu
Oulu Deaconess Institute
City of Oulu
Finnish Defence Forces
Virpiniemi Sports Institute
Investigators
Study Director: Timo Jämsä, PhD University of Oulu
Study Director: Matti Mäntysaari, MD Finnish Defence Forces
Study Director: Raija Korpelainen, PhD raija.korpelainen@odl.fi
  More Information

Additional Information:
Publications:
Responsible Party: Raija Korpelainen, professor, University of Oulu
ClinicalTrials.gov Identifier: NCT01376986     History of Changes
Other Study ID Numbers: OKM/98/627/2010
Study First Received: June 16, 2011
Last Updated: June 26, 2014
Health Authority: Finland: Ethics Committee

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 22, 2014