Activation of Young Men - Population-Based Randomised Controlled Trial

NCT01376986 | Completed DMC

• 1 other identifier: OKM/98/627/2010
• Study Type: interventional
• Target: 507
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Well-being; Quality of Life; Depression

Outcome Measures

Primary Outcomes (1)

• physical activity

  physical activity measured continuously over the 6-month trial

  6 months

Secondary Outcomes (1)

• weight

  6 months

Study Arms (2)

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.

Behavioral: physical, psychological and social activation

control

NO INTERVENTION

no access to the activation platform

Interventions

physical, psychological and social activation BEHAVIORAL

Activation

Eligibility Criteria

• Age: 17 Years - 18 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Severe physical or mental illness

Sponsors & Collaborators

• University of Oulu: lead
• Oulu Deaconess Institute: collaborator
• City of Oulu: collaborator
• Finnish Defense Forces: collaborator
• Virpiniemi Sports Institute: collaborator

Study Sites (1)

University of Oulu

Oulu, 90014, Finland

Location

Related Publications (3)

• 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.

  PMID: 23311678 BACKGROUND

• 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.

  PMID: 29017991 DERIVED

• 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.

  PMID: 26844128 DERIVED

MeSH Terms

Conditions

Obesity; Depression

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Timo Jämsä, PhD

  University of Oulu

  STUDY DIRECTOR

• Matti Mäntysaari, MD

  Finnish Defense Forces

  STUDY DIRECTOR

• Raija Korpelainen, PhD

  raija.korpelainen@odl.fi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 20, 2011
• Study Start: September 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 27, 2014

Record last verified: 2014-06

Locations

FI (1)