The MILE Study: A Motivational, Individual and Locally Anchored Exercise Intervention in 30-49 Year Olds.
NCT01801956 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2015-02-06
Summary
Background: Low levels of cardiorespiratory fitness are associated with high risk of non-communicable diseases and all-cause mortality. Physical activity level is the primary determinant of cardiorespiratory fitness in adults. However, knowledge on how to motivate people to engage in physical activity and maintain an active lifestyle is lacking. This study aims to investigate whether a motivational, individual, and locally anchored exercise intervention, in primary care, can improve cardiorespiratory fitness in 30 to 49 year olds with a low or very low cardiorespiratory fitness.
Design: Randomised controlled trial with 6 and 12 months follow-up. The primary outcome is cardiorespiratory fitness. Secondary outcomes include biochemical parameters (HbA1C, HDL- and LDL-cholesterol, and triglyceride), physical activity level (measured by accelerometer), self-reported physical activity, anthropometric parameters and health-related quality of life.
Methods: Cardiorespiratory fitness will be estimated via a maximal incremental exercise test and expressed as the index of maximum oxygen uptake per minute divided by body weight (ml O2/kg/min). A total of 236 participants, classified with a very low or low cardiorespiratory fitness at a local health check programme, (corresponding to ≤ 39 and ≤35 ml O2/kg/min. for 30-39 and 40-49 year-old men respectively and ≤33 and ≤31 ml O2/kg/min. for 30-39 and 40-49 year-old women respectively), will be randomised into two groups. The intervention group will receive 4 motivational interviews, six months membership to a sport club, and a global positioning watch to upload training activity to a social media. The comparison group will receive standard care: a one hour motivational interview. In addition to an Intention-to-treat analysis a per-protocol analysis will be performed. Effect of the intervention will be estimated by evaluating the differences in mean changes in cardiorespiratory fitness between the two groups.
Discussion:In new and innovative ways the focus of this study will be to improve cardiorespiratory fitness among a 30-49 year-old at-risk group using social media, GPS-technology, on-going personal support and individually tailored physical activity.
Conditions
- Physical Activity
Interventions
- BEHAVIORAL
-
physical activity
free membership of a sport club
- OTHER
-
Motivational interview
Four motivational interviews by instructors of the local sport club
- OTHER
-
Virtual arena
Uploading of training data from a GPS-watch to a virtual arena
Sponsors & Collaborators
-
University of Aarhus
lead OTHER
Principal Investigators
-
Kirstine H Obling, St PhD · University of Aarhus
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 49 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-02-28
- Primary Completion
- 2016-02-29
- Completion
- 2016-02-29
Countries
- Denmark
Study Locations
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