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AgingCTM-NSNCT04592614

Choose to Move - Next Steps: Can 'Booster Sessions' Sustain Health Benefits of an Effective, Scaled-up, Health Promotion Program?

A study testing Choose to Move - Next Steps in people with Aging and Mobility Limitation, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

One-third of Canadians will be older adults (>65y) by 2050. Thus, healthy aging is a public health priority. Many older adult health promoting interventions have been implemented, yet few were scaled-up and sustained. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Aging, Mobility Limitation, Sedentary Behavior
What is being tested?
Choose to Move - Next Steps
Could I receive a placebo?
No, everyone receives an active treatment
How many people
424 participants
Where
1 siteCanada
Study dates
7 Jan 2020to 29 Jan 2025
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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Provincial partners inclusion criteria: These are individuals who make strategic and policy decisions for their organization
  • Provincial coordinators inclusion criteria: These individuals coordinate and oversee delivery of programs within our delivery partner organizations.
  • Activity Coach inclusion criteria: Completed CTM training and able to connect to the Zoom or GoToMeeting platform via internet (video and audio required in order to see and hear participants) for online programs
  • Older adult inclusion criteria: English speaking, age ≥60 yrs, self-described as engaging in <150 min of moderate-to-vigorous physical activity per week and demonstrated readiness for physical activity (by the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+), Get Active Questionnaire or a letter of recommendation from their physician) before joining CTM, able to connect to the Zoom or GoToMeeting platform via phone or internet in order to participate in virtual group meetings (for online programs only), currently (or recently completed) participating in CTM evaluation

Who cannot join

  • Provincial partners, provincial coordinators and Activity Coach exclusion criteria: None
  • Older adult exclusion criteria: Non-English speaking, Unable to connect to the Zoom or GoToMeeting platform via phone or internet in order to participate in virtual group meetings

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre for Hip Health and Mobility, Robert H.N. Ho Research Centre, University of British Columbia

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

Official title: Choose to Move: How Can Health Benefits of an Effective, Scaled-up, Health Promotion Model for Older Adults be Sustained?

One-third of Canadians will be older adults (>65y) by 2050. Thus, healthy aging is a public health priority. Many older adult health promoting interventions have been implemented, yet few were scaled-up and sustained. Choose to Move (CTM) is an effective, adaptable, community-based health promotion program for older adults. CTM, co-created with government and community stakeholders, has been scaled-up across British Columbia (BC) using a phased approach (2015-2021). The investigators evaluated the impact of CTM on the health of seniors who participated and the results were extremely positive: CTM increased mobility, physical activity, social connectedness and improved mental health indicators like loneliness. When these outcomes were assessed again, one year after the end of CTM, these improvements had diminished.

In this trial the investigators aim to determine if health benefits of CTM can be maintained by providing ongoing support to CTM participants. Booster interventions have been defined as "brief contacts beyond the main part of the intervention to reinforce previous intervention content" (Fjeldsoe et al., 2011, p. 601). Choose to Move - Next Steps (CTM-NS) is a two-year intervention where participants who recently completed CTM will receive different doses of a 'booster' program. Specifically, participants will be randomly allocated to virtual group meetings on a monthly (study arm 1; high dose) or quarterly (study arm 2; low dose) basis. Group meetings will be facilitated by an Activity Coach.

Read more

Objectives:

The investigators will conduct 1) impact, 2) implementation, and 3) economic evaluations of CTM-NS across 24 months.

Hypotheses:

For objective 1, the investigators hypothesize that improvements in older adult participant outcomes (primary outcome: mobility; secondary outcomes: physical activity, loneliness, social isolation, social connectedness, sitting time, screen time, social network, health status) obtained during CTM will be maintained over the 2 year CTM-NS study. Participants in the monthly group meetings (study arm 1) will maintain benefits to a greater degree than participants in the quarterly group meetings (study arm 2). Objectives 2 and 3 are descriptive and therefore have no hypotheses.

Read the detailed description

Study Design

The investigators will use a type 2 hybrid effectiveness-implementation study design. CTM participants who choose to enrol in CTM-NS will be randomly assigned to one of two CTM-NS booster intervention arms: high dose (monthly meetings) or low dose (quarterly meetings).

Participants and Recruitment

There are 4 participant groups in this study:

  1. Provincial partners. These are individuals who make strategic and policy decisions for their organization. Provincial partners will be invited to participate in the study through written invitation and consent form delivered via email from a member of the research team. These individuals will be asked to respond to the invite and confirm or decline participation.
  2. Provincial coordinators. These individuals coordinate and oversee delivery of programs within delivery partner organizations. Provincial coordinators will be invited to participate in the study through written invitation and consent form delivered via email from a member of the research team. They will be asked to respond to the invite and confirm or decline participation.
  3. Activity Coaches. Activity Coaches are hired and contracted by delivery partners to deliver CTM-NS. They will be informed of the evaluation and invited to participate during hiring and training.
  4. Older adults. CTM evaluation participants who have recently completed CTM will be invited to participate in CTM-NS.

Intervention and Randomization

Participants will be randomized (along with any other participants from the same CTM group) by a member of the research team to one of two CTM-NS study arms. The sustainability portion of the intervention will be 24 months and consist of monthly (study arm 1; high dose) or quarterly (study arm 2; low dose) group meetings delivered remotely via the Zoom or GoToMeeting platform (password protected; access through phone or internet). Group meetings (1-hr each) of 6-11 older adults will be facilitated by a trained Activity Coach. Older adults will have the option to sign up for a bi-weekly CTM electronic newsletter containing health information and ideas and resources for older adults to be physically active and socially connected at home (and elsewhere as local restrictions permit). Within each group, Activity Coaches will also facilitate social connections between participants to encourage contact (by phone or online) outside of group sessions (for interested participants only). Groups will be combined as needed to achieve and maintain targeted group sizes. The CTM-NS intervention is only open to older adults who participated in the CTM evaluation.

Timeline

CTM will be delivered in 2 cycles:

  1. CTM Fall 2020 cycle with program start dates approximately Sept-Oct 2020;
  2. CTM Winter 2021 cycle with program start dates approximately Jan-Feb 2021.

Corresponding CTM-NS program start dates are approximately Jan-Feb 2021 (for Fall 2020 CTM programs) and April-May 2021 (for Winter 2021 CTM programs).

CTM-NS Evaluation

The investigators will use a type 2 hybrid effectiveness-implementation study design and mixed (qualitative and quantitative) methods to address the research objectives.

Participant groups will be evaluated as follows:

  1. Provincial partners will be interviewed at 12 and 24 months after the start of the first CTM-NS program. In this group the investigators assess: adaptation; innovation characteristics; community context (facilitators and barriers to implementation; sustainability of delivery).
  2. Provincial coordinators will be interviewed at 12 and 24 months after the start of the first CTM-NS program. In this group the investigators assess: reach; adaptation; community context (facilitators and barriers to implementation, sustainability of delivery); innovation characteristics; prevention support system; economic evaluation (costs associated with delivering CTM-NS).
  3. Activity Coaches will provide survey data at 3, 12, and 24 months of each CTM-NS program they deliver. A subset of Activity Coaches (n=20) will be interviewed at 3, 12, and 24 months. In this group the investigators assess: dose delivered; quality; participant responsiveness; adaptation; provider characteristics; innovation characteristics; community context (facilitators and barriers to implementation); prevention support system.
  4. Older adults will provide survey data at 0, 3, 12, and 24 months of their CTM-NS program. A subset of older adults (n=20) will be interviewed at 3, 12, and 24 months. In this group the investigators assess: reach (participant characteristics); dose received; participant responsiveness (satisfaction, engagement, enjoyment); quality; impact of CTM-NS on participant-level outcomes; how contextual factors influence program engagement and participant-level outcomes. Thus, participants will provide data at 4 time points in total: 0 (baseline for CTM-NS), 3, 12 and 24 months. Participants' baseline data from the main CTM study will be used in combination with these data to assess sustainability of outcomes (post-CTM is equivalent to baseline CTM-NS).
Being tested
Choose to Move - Next Steps
Keywords
Physical Inactivity, Sustainability, Maintenance, Behaviour Change, Physical Activity, Implementation Science, Scale-up
Medical subject headings
Mobility Limitation, Sedentary Behavior, Social Isolation, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Choose to Move - Next StepsBehavioural

    Choose to Move - Next Steps consists of a series of group meetings delivered virtually for 2 years. Group meetings (1-hr each) of 6-11 older adults will be facilitated by a trained Activity Coach and delivered remotely via the Zoom or GoToMeeting platform (password protected; access through phone or internet). Each group meeting will provide information on a health-related topic of interest and will include time for goal setting, discussion and sharing among participants. Older adults will have the option to sign up for a bi-weekly CTM electronic newsletter containing health information and ideas and resources for older adults to be physically active and socially connected at home (and elsewhere as local restrictions permit). Activity Coaches will also facilitate social connections between participants to encourage contact (by phone or online) outside of group sessions (for interested participants only).

Study groups in NCT04592614
Study groupRoleWhat they receive
High doseExperimentalCTM-NS participants receiving monthly virtual group meetings for 2 years (24 meetings total)
Receives: Behavioral: Choose to Move - Next Steps
Low doseExperimentalCTM-NS participants receiving quarterly virtual group meetings for 2 years (8 meetings total)
Receives: Behavioral: Choose to Move - Next Steps

What is being measured

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

  1. Change in mobility limitations

    Two items will assess change in a participants' ability to walk a quarter of a mile and up 10 steps (Simonsick et al., 2008). The output variable is self-reported presence of mobility-disability (no/any difficulty walking 400m or climbing one flight of stairs).

    Change will be assessed using longitudinal modelling across 0, 3, 12 and 24 months.

    Measured: 0, 3, 12, 24 months

  2. Change in physical functioning

    Change in mobility will be assessed with the Physical Functioning Subscale of the 36-Item Short Form Survey (SF-36; Ware et al., 1989). The measure asks participants to rate if their health limits them in performing 10 different activities. The output variable is an average score from 0-100 of physical functioning, where a higher score indicates a more favourable health state.

    Change will be assessed using longitudinal modelling across 0, 3, 12 and 24 months.

    Measured: 0, 3, 12, 24 months

  3. Change in self-perception of mobility

    The Mobility Assessment Tool-Short Form (MAT-sf; Rejeski et al., 2015) will be used to assess change in mobility. The MAT-sf is a validated, short form video-animated tool to assess participant self-perception of mobility. Only participants with an internet connection are able to complete this measure. The output variable is a self-rated mobility score (30-80), with higher scores indicating greater self-perception of mobility.

    Change will be assessed using longitudinal modelling across 0, 3, 12 and 24 months.

    Measured: 0, 3, 12, 24 months

Secondary outcomes (10)

  1. Change in physical activity

    The single item physical activity questionnaire will be used to measure change in physical activity (Milton, Bull \& Bauman, 2011). Output variable is self-reported number of days/week ≥30 min PA in the past week.

    Change will be assessed using longitudinal modelling across 0, 3, 12 and 24 months.

    Measured: 0, 3, 12, 24 months

  2. Change in loneliness

    The three-item loneliness scale (Hughes et al., 2004) will be used to assess change in loneliness. Participants rate three aspects of loneliness. The output variable is loneliness score (3-9); lower scores indicate lower levels of loneliness.

    Change will be assessed using longitudinal modelling across 0, 3, 12 and 24 months.

    Measured: 0, 3, 12, 24 months

  3. Change in social isolation

    Change in social isolation will be assessed using a 4-item questionnaire adapted from Vernoff, Kulka \& Douvan (1981). The output variable is social isolation score (0-15). Lower scores indicate greater levels of social isolation and higher scores indicate lower levels of social isolation.

    Change will be assessed using longitudinal modelling across 0, 3, 12 and 24 months.

    Measured: 0, 3, 12, 24 months

  4. Change in social connectedness

    A single item measure from the My Health My Community survey (2014) will be used to assess change in sense of belonging as an indicator of social connectedness. The output variable is sense of belonging score (1-4) with lower scores indicating a stronger sense of belonging.

    Change will be assessed using longitudinal modelling across 0, 3, 12 and 24 months.

    Measured: 0, 3, 12, 24 months

  5. Change in sitting time

    A five-item questionnaire (Marshall et al., 2010) will be used to assess change in sitting time (hours and minutes) each day in the following domains: (a) while travelling to and from places (e.g., work, shops); (b) while at work; (c) while watching television; (d) while using a computer at home; and (e) at leisure not including watching television (e.g., visiting friends, movies, eating out) on a weekday and a weekend day. The output variables are sitting hours per day across 5 domains.

    Change will be assessed using longitudinal modelling across 0, 3, 12 and 24 months.

    Measured: 0, 3, 12, 24 months

  6. Change in screen time

    A single item from the My Health My Community survey (My Health My Community, 2013) will be used to assess change in screen time. The output variable is the range of hours of screen time per day.

    Change will be assessed using longitudinal modelling across 0, 3, 12 and 24 months.

    Measured: 0, 3, 12, 24 months

  7. Change in social network

    Change in participant social network will be assessed using the 6-item Lubben Social Network Questionnaire (Lubben et al., 2006). The output variable is a social network score (range 0 to 30) where higher scores indicate larger social networks.

    Change will be assessed using longitudinal modelling across 0, 3, 12 and 24 months.

    Measured: 0, 3, 12, 24 months

  8. Change in health status (EQ-5D-5L Profile)

    Change in health status (EQ-5D-5L Profile) will be assessed with the EQ-5D-5L (The EuroQol Group, 1990). Participants report on mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a scale from 1-5 (level of perceived problems) for each item. Responses are used to create a 5-digit number which will be used descriptively.

    Change will be assessed descriptively across 0, 3, 12 and 24 months.

    Measured: 0, 3, 12, 24 months

  9. Change in health status (EQ-5D-5L Level Sum Score)

    Change in health status (EQ-5D-5L Level Sum Score) will be assessed with the EQ-5D-5L (The EuroQol Group, 1990). Participants report on mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a scale from 1-5 (level of perceived problems) for each item. The Level Sum Score uses the 5-digit profile to create a numeric score, with scores ranging from 5-25 (lower levels indicate lower levels of perceived problems).

    Change will be assessed using longitudinal modelling across 0, 3, 12 and 24 months.

    Measured: 0, 3, 12, 24 months

  10. Change in health status (EQ-5D-5L Visual Analogue Scale)

    Change in health status (EQ-5D-5L Visual Analogue Scale) will be assessed with the EQ-5D-5L (The EuroQol Group, 1990). Participants report on their health on a visual analogue scale from 0 (worst health) to 100 (best health).

    Change will be assessed using longitudinal modelling across 0, 3, 12 and 24 months.

    Measured: 0, 3, 12, 24 months

Timeline

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

  1. First posted19 Oct 2020
  2. Study start7 Jan 2020
  3. Primary completion29 Jan 2025
  4. Study completion29 Jan 2025

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study uses a parallel assignment intervention model. Consenting participants (older adults and activity coaches) will be randomly assigned (at the level of their CTM group) to one of two CTM-NS study arms: 1) monthly virtual group meetings (high dose), or 2) quarterly virtual group meetings (low dose). Randomization is not relevant for provincial partners and coordinators.
Masking
None (open label)
Enrolment
424 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04592614
Sponsor's protocol ID
GR012151
Other IDs
PJT-169159, H20-00780
Acronym
CTM-NS
Status last verified
Mar 2025
First submitted
22 Sep 2020
Last updated
27 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221.

    PubMed 10811152

  • Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.

    PubMed 18504506

  • Marshall AL, Miller YD, Burton NW, Brown WJ. Measuring total and domain-specific sitting: a study of reliability and validity. Med Sci Sports Exerc. 2010 Jun;42(6):1094-102. doi: 10.1249/MSS.0b013e3181c5ec18.

    PubMed 19997030

  • Milton K, Bull FC, Bauman A. Reliability and validity testing of a single-item physical activity measure. Br J Sports Med. 2011 Mar;45(3):203-8. doi: 10.1136/bjsm.2009.068395. Epub 2010 May 19.

    PubMed 20484314

  • Simonsick EM, Newman AB, Visser M, Goodpaster B, Kritchevsky SB, Rubin S, Nevitt MC, Harris TB; Health, Aging and Body Composition Study. Mobility limitation in self-described well-functioning older adults: importance of endurance walk testing. J Gerontol A Biol Sci Med Sci. 2008 Aug;63(8):841-7. doi: 10.1093/gerona/63.8.841.

    PubMed 18772472

  • EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

    PubMed 10109801

  • Lubben J, Blozik E, Gillmann G, Iliffe S, von Renteln Kruse W, Beck JC, Stuck AE. Performance of an abbreviated version of the Lubben Social Network Scale among three European community-dwelling older adult populations. Gerontologist. 2006 Aug;46(4):503-13. doi: 10.1093/geront/46.4.503.

    PubMed 16921004

  • Saunders RP, Evans MH, Joshi P. Developing a process-evaluation plan for assessing health promotion program implementation: a how-to guide. Health Promot Pract. 2005 Apr;6(2):134-47. doi: 10.1177/1524839904273387.

    PubMed 15855283

  • Durlak JA, DuPre EP. Implementation matters: a review of research on the influence of implementation on program outcomes and the factors affecting implementation. Am J Community Psychol. 2008 Jun;41(3-4):327-50. doi: 10.1007/s10464-008-9165-0.

    PubMed 18322790

  • Wiltsey Stirman S, Baumann AA, Miller CJ. The FRAME: an expanded framework for reporting adaptations and modifications to evidence-based interventions. Implement Sci. 2019 Jun 6;14(1):58. doi: 10.1186/s13012-019-0898-y.

    PubMed 31171014

  • Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

    PubMed 28851459

  • Fjeldsoe B, Neuhaus M, Winkler E, Eakin E. Systematic review of maintenance of behavior change following physical activity and dietary interventions. Health Psychol. 2011 Jan;30(1):99-109. doi: 10.1037/a0021974.

    PubMed 21299298

  • Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.

    PubMed 20957426

Questions about this trial

What is this clinical trial studying?

A study testing Choose to Move - Next Steps in people with Aging and Mobility Limitation, run by University of British Columbia 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 4 inclusion and 2 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 27 Mar 2025. 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?

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?

Change in mobility limitations (time frame: 0, 3, 12, 24 months). The study lists 3 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 NCT04592614, which also lists 13 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 27 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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