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

NCT03906162 | Completed DMC

• 1 other identifier: 18004960
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Physical Activity; Older Adults

Keywords

physical activity monitors; motivational interviewing; walking; fitness-tracker; social cognitive theory; older age

Outcome Measures

Primary Outcomes (1)

• Individual intervention period average of PAM measured steps per day

  Daily step counts will be objectively measured by the PAM.

  A daily average of the 12 weeks of intervention

Secondary Outcomes (6)

• International Physical Activity Questionnaire

  Baseline + end point at 12 weeks + follow up at 6 months and 12 months

• Nordic Physical Activity Questionnaire

  Baseline + end point at 12 weeks + follow up at 6 months and 12 months

• EQ5D Quality of life questionnaire

  Baseline + end point at 12 weeks + follow up at 6 months and 12 months

• University of California, Los Angeles, Loneliness Scale

  Baseline + end point at 12 weeks + follow up at 6 months and 12 months

• Self Efficacy for Exercise

  Baseline + end point at 12 weeks + follow up at 6 months and 12 months

Study Arms (2)

Motivational interviewing

EXPERIMENTAL

Experimental content + base intervention

Behavioral: Motivational interviews; Behavioral: Base intervention

Control intervention

ACTIVE COMPARATOR

Base intervention

Behavioral: Base intervention

Interventions

Motivational interviews BEHAVIORAL

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".

Motivational interviewing

Base intervention BEHAVIORAL

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; Motivational interviewing

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Participants must:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Rasmus Tolstrup

Copenhagen, 1663, Denmark

Location

Related Publications (2)

• 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.

  PMID: 34215176 DERIVED

• 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.

  PMID: 33081715 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Primary investigator will be blinded for allocation before making the final analyses. No outcome assessments will be made by an assessor. Only objectively measured steps per day and participant reported outcome measures will be used for this study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 12 week intervention with two groups in a parallel design

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 8, 2019
• Study Start: April 4, 2019
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Five years from published paper

Locations

DK (1)