AgingMIPAMNCT03906162
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
A study testing Motivational interviews and Base intervention in people with Aging and Physical Activity, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Physical Activity, Older Adults
- What is being tested?
- Motivational interviews and Base intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Apr 2019to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Motivational interviews, Base intervention
- Keywords
- physical activity monitors, motivational interviewing, walking, fitness-tracker, social cognitive theory, older age
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewsBehavioural
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 interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Motivational interviewing | Experimental | Experimental content + base intervention Receives: Behavioral: Motivational interviews; Behavioral: Base intervention |
| Control intervention | Active comparator | Base intervention Receives: Behavioral: Base intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual intervention period average of PAM measured steps per day
Daily step counts will be objectively measured by the PAM.
Measured: A daily average of the 12 weeks of intervention
Secondary outcomes (6)
International Physical Activity Questionnaire
Questionnaire: The seven-item IPAQ-SF measure assesses the types of intensity of physical activity and sitting time that people has done the past seven days as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting.
Measured: Baseline + end point at 12 weeks + follow up at 6 months and 12 months
Nordic Physical Activity Questionnaire
Questionnaire: It is developed to monitor compliance with the WHO recommendations on PA.
Measured: Baseline + end point at 12 weeks + follow up at 6 months and 12 months
EQ5D Quality of life questionnaire
Questionnaire: The EQ-5D-5L is a generic health-related quality of life (HRQoL) measure developed as a non-disease-specific instrument for describing and valuing health states and comprises five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each of which has three levels (no problems, moderate problems and extreme problems) and a visual analogue scale (EQ VAS). The score for the five dimensions can be combined into a five-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Measured: Baseline + end point at 12 weeks + follow up at 6 months and 12 months
University of California, Los Angeles, Loneliness Scale
Questionnaire: The 20-item UCLA loneliness scale (third version) is a self-report measure of loneliness and social isolation. The scale consists of 11 positive and nine negative items and the total score is calculated by finding the sum of 20 items (0-60), with a higher score indicating more loneliness.
Measured: Baseline + end point at 12 weeks + follow up at 6 months and 12 months
Self Efficacy for Exercise
Questionnaire: The nine-item SEE-DK addresses confidence to engage in regular exercise [44], when challenged by known barriers to exercise. The scale was developed initially for sedentary adults in the community who participated in an outpatient exercise program and was revised to older adults. It is designed to be administered using face-to-face interview. Response categories range from 0 (no confidence) to 10 (very confident). Item scores are used to calculate a total score (0-90), with higher scores indicating higher confidence, or self-efficacy, related to exercise. The SEE-DK is adapted to Danish older adults with acceptable face and content validity, construct validity by acceptable model fit as a unidimensional scale, and test-retest reliability.
Measured: Baseline + end point at 12 weeks + follow up at 6 months and 12 months
Outcome expectancy for Exercise
Questionnaire: The 13-item OEE-2 scale was developed from the original 9-item Outcome Expectations for Exercise scale (OEE) that specifically focused on measuring the positive outcome expectations for exercise (POEE). To complete the OEE2-DK scale the participants are asked, using a Likert scale, to strongly agree, agree, neither agree nor disagree, disagree, or strongly disagree with the stated outcomes to each statement of exercising.
Measured: Baseline + end point at 12 weeks + follow up at 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start4 Apr 2019
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 12 week intervention with two groups in a parallel design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasmus Tolstrup Larsen, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906162
- Sponsor's protocol ID
- 18004960
- Acronym
- MIPAM
- Status last verified
- Oct 2020
- First submitted
- 1 Apr 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Fully anonymised data set will be published with the published paper
Publications
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.
PubMed 34215176Larsen 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.
PubMed 33081715
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03906162
- Acronym / sponsor ID
- MIPAM / 18004960
- Conditions
- Aging, Physical Activity, Older Adults
- Keywords
- physical activity monitors, motivational interviewing, walking, fitness-tracker, social cognitive theory, older age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 12 week intervention with two groups in a parallel design
| Arm | Type | Receives |
|---|---|---|
| Motivational interviewing | Experimental | Behavioral: Motivational interviews, Behavioral: Base interventionExperimental content + base intervention |
| Control intervention | Active comparator | Behavioral: Base interventionBase intervention |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewsDuring 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". | Behavioural | Motivational interviewing |
| Base interventionThe "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. | Behavioural | Control intervention, Motivational interviewing |
Primary outcome
Individual intervention period average of PAM measured steps per day
Time frame: A daily average of the 12 weeks of intervention
Daily step counts will be objectively measured by the PAM.
6 secondary outcomes
International Physical Activity Questionnaire
Time frame: Baseline + end point at 12 weeks + follow up at 6 months and 12 months
Nordic Physical Activity Questionnaire
Time frame: Baseline + end point at 12 weeks + follow up at 6 months and 12 months
EQ5D Quality of life questionnaire
Time frame: Baseline + end point at 12 weeks + follow up at 6 months and 12 months
University of California, Los Angeles, Loneliness Scale
Time frame: Baseline + end point at 12 weeks + follow up at 6 months and 12 months
Self Efficacy for Exercise
Time frame: Baseline + end point at 12 weeks + follow up at 6 months and 12 months
Outcome expectancy for Exercise
Time frame: Baseline + end point at 12 weeks + follow up at 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 34215176Larsen 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.
- Derived from this study: PubMed 33081715Larsen 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.
- Individual participant dataSharing planned: Yes. Fully anonymised data set will be published with the published paper
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviews and Base intervention in people with Aging and Physical Activity, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individual intervention period average of PAM measured steps per day (time frame: A daily average of the 12 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03906162, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.