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

No results posted yet for this study

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01801956 on ClinicalTrials.gov