Clinical trial NCT03906162: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Physical Activity
Older Adults
Keywords: physical activity monitors
motivational interviewing
walking
fitness-tracker
social cognitive theory
older age
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 65
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 12 week intervention with two groups in a parallel design
Primary purpose: PREVENTION

Brief summary: To investigate if motivational-interviewing will enhance the expected effect from physical activity monitors, on physical activity in older adults, we will conduct a two-arm randomized controlled trial in 2019.

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.


Eligibility criteria: Inclusion Criteria:

Participants must:

* Be minimum 70 years of age at the time of inclusion
* Own and use an Apple/Google/Microsoft smartphone device compatible with the Garmin Connect™ 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:

Participants cannot

* 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.

Primary outcomes:
measure: Individual intervention period average of PAM measured steps per day
timeFrame: A daily average of the 12 weeks of intervention
Secondary outcomes:
measure: International Physical Activity Questionnaire
timeFrame: Baseline + end point at 12 weeks + follow up at 6 months and 12 months
measure: Nordic Physical Activity Questionnaire
timeFrame: Baseline + end point at 12 weeks + follow up at 6 months and 12 months
measure: EQ5D Quality of life questionnaire
timeFrame: Baseline + end point at 12 weeks + follow up at 6 months and 12 months
measure: University of California, Los Angeles, Loneliness Scale
timeFrame: Baseline + end point at 12 weeks + follow up at 6 months and 12 months
measure: Self Efficacy for Exercise
timeFrame: Baseline + end point at 12 weeks + follow up at 6 months and 12 months
measure: Outcome expectancy for Exercise
timeFrame: Baseline + end point at 12 weeks + follow up at 6 months and 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rasmus Tolstrup
Study officials:
References:
citation: 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.
citation: 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.