A 12-week Intervention With Motivational Interviewing and Physical Activity Monitoring, to Enhance the Daily Amount of Physical Activity in Community Dwelling Older Adults - a Randomized Controlled Trial
NCT ID: NCT03906162
Last Updated: 2020-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
65 participants
INTERVENTIONAL
2019-04-04
2020-03-15
Brief Summary
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Both groups in the trial will receive a physical activity monitor for everyday use in the 12-week intervention period and a folder with information about the benefits of physical activity in older age. Participants in the intervention group will in addition to the use of the physical activity monitors receive a motivational feedback session by phone of about 20 minutes constructed from the theoretical framework of Motivational interviewing by Rollnick, Miller \& Butler and Social Cognitive Theory by Bandura. The content of the session focuses on investigating the most relevant possibilities and barriers for the participant to increase his or her levels of PA.
The primary outcome will be between group difference in average steps per day throughout the intervention period, measured objectively by the physical activity monitor (Garmin Vivofit 3). Secondary outcomes include participant reported outcome measures such as 'International Physical Activity Questionnaire', 'Nordic Physical Activity Questionnaire', 'EQ5D Quality of life questionnaire', 'UCLA Loneliness Scale', 'Self Efficacy for Exercise', and 'Outcome expectancy for Exercise'. To ensure 80% power with an alpha-level on 0.05, we will include 128 participants. The study will enroll in March 2019.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Motivational interviewing
Experimental content + base intervention
Motivational interviews
During the 12-week intervention, the participants will receive seven telephone calls from a physical therapist. The interviews will be held in week 1, 2,3,5,7,9, and 12.
The telephone call will consist of a motivational interview focused on enhancing the daily level of physical activity in the participants.
MI is a form of counselling aiming at prompting increases in self-efficacy, which may leave people more open to and invested in changing their behaviours and shows potential for significant effects for exercise behaviour change.
In addition to the telephone based motivational interviews, the experimental group will also receive the "base intervention" which is described in detail under the "control intervention paragraph".
Base intervention
The "base intervention" consists of a physical activity monitor (PAM) for everyday use in the intervention period and a pamphlet with information about Danish recommendations on physical activity in aging populations. The PAM will be the Garmin Vivofit 3 monitor linked to a pre-specified Garmin Connect account. The participants will be asked to install the Garmin Connect application on their smartphone and use the given ID/password in the app. The participants will be asked to wear the monitor 24-hours a day for the 12-week intervention period. The participants can use the PAM as they like but they will be asked to try to use the PAM and the application to enhance their daily level of physical activity.
Control intervention
Base intervention
Base intervention
The "base intervention" consists of a physical activity monitor (PAM) for everyday use in the intervention period and a pamphlet with information about Danish recommendations on physical activity in aging populations. The PAM will be the Garmin Vivofit 3 monitor linked to a pre-specified Garmin Connect account. The participants will be asked to install the Garmin Connect application on their smartphone and use the given ID/password in the app. The participants will be asked to wear the monitor 24-hours a day for the 12-week intervention period. The participants can use the PAM as they like but they will be asked to try to use the PAM and the application to enhance their daily level of physical activity.
Interventions
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Motivational interviews
During the 12-week intervention, the participants will receive seven telephone calls from a physical therapist. The interviews will be held in week 1, 2,3,5,7,9, and 12.
The telephone call will consist of a motivational interview focused on enhancing the daily level of physical activity in the participants.
MI is a form of counselling aiming at prompting increases in self-efficacy, which may leave people more open to and invested in changing their behaviours and shows potential for significant effects for exercise behaviour change.
In addition to the telephone based motivational interviews, the experimental group will also receive the "base intervention" which is described in detail under the "control intervention paragraph".
Base intervention
The "base intervention" consists of a physical activity monitor (PAM) for everyday use in the intervention period and a pamphlet with information about Danish recommendations on physical activity in aging populations. The PAM will be the Garmin Vivofit 3 monitor linked to a pre-specified Garmin Connect account. The participants will be asked to install the Garmin Connect application on their smartphone and use the given ID/password in the app. The participants will be asked to wear the monitor 24-hours a day for the 12-week intervention period. The participants can use the PAM as they like but they will be asked to try to use the PAM and the application to enhance their daily level of physical activity.
Eligibility Criteria
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Inclusion Criteria
* Be minimum 70 years of age at the time of inclusion
* Own and use an Apple/Google/Microsoft smartphone device compatible with the Garmin Connectâ„¢ Mobile application.
* Own use an e-mail account
* Live in Denmark and have a Danish postal address and be able to receive the intervention content.
* Be able to walk independently with or without assistive devices.
Exclusion Criteria
* Receive active cancer treatment
* Have major cognitive impairment (e.g. dementia or alzheimers).
* Parkinson's or Multiple Sclerosis (or similar disease) affecting their mobility in such a way that the participants cannot walk on a daily basis.
70 Years
ALL
Yes
Sponsors
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University of Copenhagen
OTHER
Responsible Party
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Rasmus Tolstrup Larsen
Principal investigator
Locations
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Rasmus Tolstrup
Copenhagen, , Denmark
Countries
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References
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Larsen RT, Korfitsen CB, Keller C, Christensen J, Andersen HB, Juhl C, Langberg H. The MIPAM trial - motivational interviewing and physical activity monitoring to enhance the daily level of physical activity among older adults - a randomized controlled trial. Eur Rev Aging Phys Act. 2021 Jul 2;18(1):12. doi: 10.1186/s11556-021-00269-7.
Larsen RT, Korfitsen CB, Juhl CB, Andersen HB, Christensen J, Langberg H. The MIPAM trial: a 12-week intervention with motivational interviewing and physical activity monitoring to enhance the daily amount of physical activity in community-dwelling older adults - a study protocol for a randomized controlled trial. BMC Geriatr. 2020 Oct 20;20(1):412. doi: 10.1186/s12877-020-01815-1.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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18004960
Identifier Type: -
Identifier Source: org_study_id
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