Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 278 for:    the mile study
Previous Study | Return to List | Next Study

The MILE Study: A Motivational, Individual and Locally Anchored Exercise Intervention in 30-49 Year Olds. (MILE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01801956
Recruitment Status : Unknown
Verified October 2013 by University of Aarhus.
Recruitment status was:  Recruiting
First Posted : March 1, 2013
Last Update Posted : February 6, 2015
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief 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.


Condition or disease Intervention/treatment Phase
Physical Activity Behavioral: physical activity Other: Motivational interview Other: Virtual arena Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: The MILE Study: A Motivational, Individual and Locally Anchored Exercise Intervention Among 30-49 Year-olds With Low Levels of Cardiorespiratory Fitness. A Randomised Controlled Study in Primary Care.
Study Start Date : February 2013
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Motivational interviewing
A one hour motivational interview
Other: Motivational interview
Four motivational interviews by instructors of the local sport club

Experimental: Physical activity
Four motivational interviews, free membership of a sport club, virtual arena to upload training data from a GPS-watch
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




Primary Outcome Measures :
  1. Maximum oxygen uptake [ Time Frame: Change from baseline maximum oxygen uptake at 6 and 12 months. ]
    The outcome is measured by an indirectly standardized and validated max imalergometer bicycle test. The bicycle is cycled at 100 watt (women 70 watt). Every second minute the load is increased by 35 watt until the load causes fatigue. The highest load achieved, the time spent cycling at the highest load and the weight of the participant are put into a formula and the CRF is estimated


Secondary Outcome Measures :
  1. Physical activity [ Time Frame: Change from baseline physical activity at 6 and 12 months. ]
    Physical activity is measured by an accelerometer. The accelerometer is affixed with a plaster on the right anterior axillary line of the participant and worn day and night for 7 days.


Other Outcome Measures:
  1. Biochemical variables [ Time Frame: Change from baseline biochemical varibles at 12 months. ]
    This study will measure relevant plasma markers by means of a capillary test (HbA1c, HDL- and LDL-cholesterol, triglyceride).

  2. Sedentary behavior [ Time Frame: Change from baseline sedentary behavior at 6 and 12 months. ]
    Sedentary behavior is measured by an accelerometer. The accelerometer is affixed with a plaster on the right anterior axillary line of the participant and worn day and night for 7 days.

  3. Anthropometric variables [ Time Frame: Change from baseline antropometric variables at 12 months. ]
    BMI, waist and hip circumference

  4. self-reported health [ Time Frame: Change from baseline self-reported health at 12 months. ]
    SF-12 questionnaire



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 30-49 years old
  • access to e-mail and internet
  • a low or very low VO2max

Exclusion Criteria:

  • health problems preventing participation
  • on medication with a beta-blocker
  • pregnancy
  • alcoholism
  • unable to communicate with the staff.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801956


Contacts
Layout table for location contacts
Contact: Kirstine H Obling, St PhD +4587167914 kirstine.obling@ph.au.dk
Contact: Helle T Maindal, PhD htm@alm.au.dk

Locations
Layout table for location information
Denmark
Aarhus University, Department of Public Health Recruiting
Aarhus, Denmark, 8000
Contact: Kirstine H Obling, St PhD         
Sub-Investigator: Helle T Maindal, PhD         
Principal Investigator: Kirstine H Obling, St PhD         
Sub-Investigator: Kristian Overgaard, PhD         
Aarhus University Recruiting
Aarhus, Denmark, 8000
Contact: Kirstine H Obling, St. Ph.D       kirstine.obling@alm.au.dk   
Sub-Investigator: Helle Maindal Terkildsen, PhD         
Principal Investigator: Kirstine Obling, St. Ph.D         
Aarhus University Recruiting
Aarhus, Denmark, 8000
Contact: Kirstine H Obling, St. Ph.D    +4525211009    kirstine.obling@ph.au.dk   
Principal Investigator: Kirstine H Obling, St. Ph.D         
Sponsors and Collaborators
University of Aarhus
Investigators
Layout table for investigator information
Principal Investigator: Kirstine H Obling, St PhD University of Aarhus

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01801956    
Other Study ID Numbers: 1-10-72-428-12
First Posted: March 1, 2013    Key Record Dates
Last Update Posted: February 6, 2015
Last Verified: October 2013
Keywords provided by University of Aarhus:
Maximum oxygen uptake
Physical activity
Physical inactivity
Motivational interview
Cardiorespiratory fitness
Primary care
Community care