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

NCT01801956 | Unknown DMC

• 1 other identifier: 1-10-72-428-12
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

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.

Conditions

Physical Activity

Keywords

Maximum oxygen uptake; Physical activity; Physical inactivity; Motivational interview; Cardiorespiratory fitness; Primary care; Community care

Outcome Measures

Primary Outcomes (1)

• Maximum oxygen uptake

  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

  Change from baseline maximum oxygen uptake at 6 and 12 months.

Secondary Outcomes (1)

• Physical activity

  Change from baseline physical activity at 6 and 12 months.

Other Outcomes (4)

• Biochemical variables

  Change from baseline biochemical varibles at 12 months.

• Sedentary behavior

  Change from baseline sedentary behavior at 6 and 12 months.

• Anthropometric variables

  Change from baseline antropometric variables at 12 months.

Study Arms (2)

Motivational interviewing

ACTIVE COMPARATOR

A one hour motivational interview

Other: Motivational interview

Physical activity

EXPERIMENTAL

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

Behavioral: physical activity; Other: Motivational interview; Other: Virtual arena

Interventions

physical activity BEHAVIORAL

free membership of a sport club

Physical activity

Motivational interview OTHER

Four motivational interviews by instructors of the local sport club

Motivational interviewing; Physical activity

Virtual arena OTHER

Uploading of training data from a GPS-watch to a virtual arena

Physical activity

Eligibility Criteria

• Age: 30 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (3)

Aarhus University, Department of Public Health

Aarhus, 8000, Denmark

RECRUITING

Aarhus University

Aarhus, 8000, Denmark

RECRUITING

Aarhus University

Aarhus, 8000, Denmark

RECRUITING

Related Publications (2)

• Obling KH, Overgaard K, Juul L, Maindal HT. Effects of a motivational, individual and locally anchored exercise intervention (MILE) on cardiorespiratory fitness: a community-based randomised controlled trial. BMC Public Health. 2019 Feb 28;19(1):239. doi: 10.1186/s12889-019-6556-0.

  PMID: 30819145 DERIVED

• Obling KH, Overgaard K, Juul L, Maindal HT. 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. BMC Public Health. 2013 Dec 23;13:1224. doi: 10.1186/1471-2458-13-1224.

  PMID: 24365174 DERIVED

MeSH Terms

Conditions

Motor Activity; Sedentary Behavior

Interventions

Exercise; Motivational Interviewing

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kirstine H Obling, St PhD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirstine H Obling, St PhD

CONTACT

+4587167914; kirstine.obling@ph.au.dk

Helle T Maindal, PhD

CONTACT

htm@alm.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: March 1, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 6, 2015

Record last verified: 2013-10

Locations

DK (3)