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Motivational InterviewingNCT05179148

MI for Physical Activity Among Older Adults

A study testing Motivational Interviewing in people with Motivational Interviewing, run by University of Manitoba at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine the feasibility of VIrtual Motivational INTerviewing (VIMINT) to promote physical activity levels among older adults; post-intervention and at two-month follow-up. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Motivational Interviewing
What is being tested?
Motivational Interviewing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteCanada
Study dates
23 Mar 2022to 30 Mar 2023
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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • aged 65 years or older
  • living in the community
  • able to walk with or without mobility aid for at least 10 metres
  • physically inactive i.e., less than 150 minutes of moderate-vigorous intensity
  • ready to participate in physical activity and no medical concerns using the Physical Activity Readiness Questionnaire (PAR-Q+)*
  • score of ≥ 18 on the telephone version of the Mini-mental State Exam
Show all 9Show fewer
  • able to speak English
  • able to have access to a computer, tablet or mobile phone capable of running the videoconferencing platform (Zoom)
  • able to access internet and email

Who cannot join

  • • receiving on-going treatment for any medical condition that would prevent safe participation in physical activity
  • living in long-term care
  • participating in other behavioural interventions that focus on improving physical activity

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Manitoba

    Winnipeg, Manitoba

Other trials in Canada

About this study

Official title: Motivational Interviewing for Physical Activity Among Older Adults

The purpose of this study is to determine the feasibility of VIrtual Motivational INTerviewing (VIMINT) to promote physical activity levels among older adults; post-intervention and at two-month follow-up.

Read the detailed description

Evidence shows that moderate and regular physical activity is associated with the prevention of non-communicable diseases, increased bone density, reduced risk of dementia, and prevention of falls among older adults. Despite the numerous benefits of physical activity, many older adults do not meet the recommended physical activity guidelines of 150 min/week of moderate-to-vigorous intensity physical activity in Canada. MI is a client-centered counselling style for strengthening a person's own motivation and commitment to change. MI helps evoke the person's own motivation for changes through reflective listening, engaging, evoking, and planning. MI has shown to be promising in the general adult population for improving physical activity levels, however, there were mixed results for the effectiveness of MI among older adults. In addition, based on the available evidence, there are no studies evaluating the potential long-term effects of MI on physical activity levels among older adults. This feasibility study is necessary to explore possible challenges that may be encountered in the future larger trial with a two-month follow-up. Due to the recent pandemic (COVID-19), the intervention will be conducted virtually through the videoconferencing platform (Zoom). Therefore, the purpose of this study is to determine the feasibility of VIrtual Motivational INTerviewing (VIMINT) to promote physical activity levels among older adults; post-intervention and at two-month follow-up.

The participants will receive five sessions of the virtual MI over a five-week period through the Zoom platform and each session will last between 45 to 60 minutes. The intervention will be delivered by trained personnel in MI. The MI strategies will include evoking change and guiding participants in establishing goals for improving physical activity. After the 2-month evaluation, counsellors and participants will be invited for a one-on-one Zoom interview. The aim is to explore the perception of the counsellors and participants about the VIMINT study including, views about virtual MI, benefits, and challenges.

Being tested
Motivational Interviewing
Keywords
motivational interviewing, physical activity, older adults, virtual
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 InterviewingBehavioural

    MI is a client-centered counselling style for strengthening a person's own motivation and commitment to change. MI helps evoke the person's own motivation for changes through reflective listening, engaging, evoking, and planning

Study groups in NCT05179148
Study groupRoleWhat they receive
interventionExperimentalThe arm will receive motivational interviewing
Receives: Behavioral: Motivational Interviewing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total number of participants recruited per month

    The recruitment rate is the number of participants screened, the number of those who provide written informed consent and the percentage of those who attend the baseline assessment

    Measured: throughout the study, average of 1 year

  2. the percentage of participants that remained after the last data is completed at 1 year

    Total number of participants that completed the follow-up assessment at 3 months post-baseline divided by the total number of participants that completed the post-intervention assessment at 1 month post-baseline

    Measured: after completion of data collection at 1 year

  3. the counsellor's competence will be assessed using Motivational Interviewing Treatment Integrity Code 4.2.1 after completing the motivational interviewing counselling at 1 month post-baseline assessment

    The counsellor's competence will be assessed by listening to the audio recorded MI sessions using the global score on the Motivational Interviewing Treatment Integrity Code (MITI 4.2.1.) MITI 4.2.1 consists of four global ratings for the counsellor: cultivating Change talk, Softening Sustain Talk, Partnership, and Empathy. Each of the four global ratings are scored on a five-point Likert scale with "1" and "5" as the lowest and highest proficiency respectively.

    Measured: at 1 month post baseline

  4. participant level of satisfaction will be assessed using the Client Satisfaction Questionnaire version 8 at follow-up assessment which is 3 months post baseline

    The Client Satisfaction Questionnaire version 8 is an 8-item scale that is scored using a Likert from 1 (quite dissatisfied) to 4 (very satisfied). The score ranges from 8 to 32, with a higher score representing higher satisfaction

    Measured: 3 months post baseline

Secondary outcomes (6)

  1. change from baseline of self-reported light, moderate and vigorous using Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire at 1 month and 3 months

    CHAMPS is a 41-item questionnaire. We will administer the CHAMPS questionnaire through the Zoom platform at baseline, 1 month, and 3 months post baseline. The participants will be asked to indicate if they engage in an activity, and if the participants indicate "NO" they will be scored zero. Any activities the participants indicate "YES," we will ask how many times they engage in the activity in a week. Afterward, the participants will be asked to select the total hours/week they engage in the activity from the following six categories: less than 1 hr, 1-2½ hrs, 3-4½ hrs, 5-6½ hrs, 7-8½ hrs, and 9 hrs or more. Each activity on the CHAMPS is assigned a Metabolic equivalent (MET) value as recommended by Stewart et al. (2001). We will compute the total hours/week; a MET value of ≥ 3.0 and ≥ 5.0 will be defined as moderate-vigorous and vigorous intensity physical activity respectively.

    Measured: baseline, 1 month and 3 months post baseline

  2. Change from baseline in the total sporadic minutes per day of the light and moderate-vigorous intensity physical activity and total number of steps per day using activity monitor(GT3X+ model) at 1 months and 3 months

    Participants will be asked to wear the activity monitor on an elastic waistband over the right hip for at least 10 waking hours for seven consecutive days. low frequency extension (LFE) option to capture the various physical activity intensities. The light and moderate-vigorous intensity physical activity will be analyzed using the cut point of 100-759 and ≥760 counts per minute respectively.

    Measured: baseline, 1 month and 3 months post baseline

  3. Change from baseline in the quality of life using The Research ANd Development-36 (RAND-36) at 1 month and 3 months

    RAND-36 is a 36-item generic measure of the HRQoL that assesses eight health concepts: physical functioning (10 items), role limitations due to physical health problem (4 items), role limitations due to emotional problems (3 items), social functioning (2 items), emotional well-being (5 items), energy/fatigue (4 items), pain (2 items), and general health perceptions (5 items). RAND-36 also assesses change in perceived health during the last 12 months using a single item. Each item has different response categories (1-6), which are then transformed to various values as recommended by Hays and Morales (2001). The score ranges between 0 and 100 (SD =10) with a higher score indicating better physical or mental health.

    Measured: baseline, 1month and 3 months post baseline

  4. change from baseline in the mean self-efficacy for exercise using 9-item Self-efficacy for exercise questionnaire at 1 month and 3 months

    It is a 9-item instrument with responses ranging from 0 (not confident) to 10 (very confident), and a higher score indicating higher self-efficacy for physical activity or exercise. The scoring is calculated by summing up the total score and dividing by the number of items (nine).

    Measured: baseline, 1month and 3 months post baseline

  5. change from baseline in the mean of task self-efficacy physical activity using 10 items from task self-efficacy physical activity questionnaire at 1 month and 3 months post baseline.

    the self-efficacy physical activity questionnaire is a 10-item, participants will be asked to rate their level of confidence on a scale 0 (not at all confidence) and 100 (completely confident). The ratings will be summed and averaged to give a score of task self-efficacy physical activity score.

    Measured: baseline, 1month and 3 months post baseline

  6. change from baseline in the readiness of the participant to change behaviour using readiness-to-change ruler at baseline and 1 month post baseline

    the readiness-to-change ruler is an arbitrary line on a scale of 0 to 10 where 0 means "Not ready to change," and 10 means "Ready to change''. The readiness-to-change ruler helps to gauge the motivational and ambivalence state of an individual. Typically, the scores are interpreted with 0-3 as "not ready", 4-7 as "ambivalence or not sure" and 8-10 as "ready for change".

    Measured: baseline and 1 month post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2022
  2. Study start23 Mar 2022
  3. Primary completion30 Aug 2022
  4. Study completion30 Mar 2023 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05179148
Sponsor's protocol ID
HS25249 (H2021:396)
Status last verified
Dec 2022
First submitted
6 Dec 2021
Last updated
12 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sun F, Norman IJ, While AE. Physical activity in older people: a systematic review. BMC Public Health. 2013 May 6;13:449. doi: 10.1186/1471-2458-13-449.

    PubMed 23648225

  • Vogel T, Brechat PH, Lepretre PM, Kaltenbach G, Berthel M, Lonsdorfer J. Health benefits of physical activity in older patients: a review. Int J Clin Pract. 2009 Feb;63(2):303-20. doi: 10.1111/j.1742-1241.2008.01957.x.

    PubMed 19196369

  • Miller WR, Rollnick S. The methods of motivational interviewing Motivational interviewing: Helping people change. 3rd ed. New York, NY: Guilford press; 2013. p. 29

  • O'Halloran PD, Blackstock F, Shields N, Holland A, Iles R, Kingsley M, Bernhardt J, Lannin N, Morris ME, Taylor NF. Motivational interviewing to increase physical activity in people with chronic health conditions: a systematic review and meta-analysis. Clin Rehabil. 2014 Dec;28(12):1159-71. doi: 10.1177/0269215514536210. Epub 2014 Jun 18.

    PubMed 24942478

  • Brodie DA, Inoue A. Motivational interviewing to promote physical activity for people with chronic heart failure. J Adv Nurs. 2005 Jun;50(5):518-27. doi: 10.1111/j.1365-2648.2005.03422.x.

    PubMed 15882368

  • O'Halloran PD, Shields N, Blackstock F, Wintle E, Taylor NF. Motivational interviewing increases physical activity and self-efficacy in people living in the community after hip fracture: a randomized controlled trial. Clin Rehabil. 2016 Nov;30(11):1108-1119. doi: 10.1177/0269215515617814. Epub 2016 Jul 11.

    PubMed 26603892

  • Quirk F, Dickinson C, Baune B, Leicht A, Golledge J. Pilot trial of motivational interviewing in patients with peripheral artery disease. Int Angiol. 2012 Oct;31(5):468-73.

    PubMed 22990510

  • Akinrolie O, Barclay R, Strachan S, Gupta A, Jasper US, Jumbo SU, et al. The effect of motivational interviewing on physical activity level among older adults: a systematic review and meta-analysis. Physical & occupational therapy In Geriatrics. 2020;38(3):250-63

Questions about this trial

What is this clinical trial studying?

A study testing Motivational Interviewing in people with Motivational Interviewing, run by University of Manitoba at 1 site in Canada.

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 9 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Dec 2022. 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 Canada. 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?

Results are not available in the source record.

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?

Total number of participants recruited per month (time frame: throughout the study, average of 1 year). The study lists 4 primary outcomes in all. 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 NCT05179148, which also lists 8 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 12 Dec 2022.

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