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AgingNCT06434298

Provincial Scale-up of Choose to Move (CTM) Phase 4

A study testing Choose to Move in people with Aging and Physical Inactivity, run by University of British Columbia at 1 site in Canada.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Choose to Move (CTM) is a 3-month, choice-based health-promoting program for low active older adults being scaled-up across British Columbia (BC), Canada. In this project, the investigators will expand delivery of the optimized Phase 4 program with large and small partner organizations and will describe and assess… Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Aging, Physical Inactivity, Mobility Limitation
What is being tested?
Choose to Move
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,720 participants
Where
1 siteCanada
Study dates
1 Sep 2023to 30 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Central support unit staff member
  • Activity coach hired by delivery partner organization (activity coaches must speak English to participate in the evaluation);
  • English-speaking older adults (aged >=50 years) who participate in CTM (recruited by delivery partner organizations) will be invited to participate in the evaluation;
  • Non-English speaking older adults will also be invited to participate in the evaluation as long as an intermediary who has the necessary language skills to ensure effective communication/translation of the consent and surveys is present.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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: Continued Evaluation of Provincial Scale-up of Choose to Move (CTM) Phase 4

Choose to Move (CTM) is a 3-month, choice-based health-promoting program for low active older adults being scaled-up across British Columbia (BC), Canada. In this project, the investigators will expand delivery of the optimized Phase 4 program with large and small partner organizations and will describe and assess scale-up, implementation, and impact of CTM Phase 4.

Read the detailed description

Choose to Move (CTM) a 3-month, choice-based health-promoting program for low active older adults being scaled-up in phases across British Columbia (BC), Canada. To date (Phases 1-4), CTM participants have included mostly white older women living in large urban centres. In this project, the investigators aim to expand the reach of CTM to include even more older adults living in communities across BC.

Within CTM (Phase 4), trained activity coaches support older adults in two ways. First, in a one-on-one consultation, activity coaches help participants to set goals and create action plans for physical activity tailored to each person's interests and abilities. Older adults can choose to participate in individual or group-based activities. Second, activity coaches facilitate 8 group meetings with small groups of participants either in person or online.

In this study, the central support unit (CSU) will work with community-based seniors' services (CBSS) organizations in large and small communities across BC to deliver CTM to more older adults. The investigators will then evaluate implementation of CTM programs, and the impact of the CTM program on older adults' physical and social health.

Objectives:

To assess whether CTM (Phase 4) was implemented as planned (fidelity) and investigate factors that support or inhibit its implementation at scale across BC (Part I - Implementation Evaluation).

To assess the impact (effectiveness) of CTM (Phase 4) on the physical activity, mobility, and social connectedness of older adult participants (Part II - Impact Evaluation).

Study Design:

The investigators use a hybrid type 2 effectiveness-implementation (Curran et al. 2012) pre-post study design to evaluate scale-up of CTM Phase 4. The investigators use mixed methods (quantitative and qualitative) and collect data at 0 (baseline) and 3 (post-intervention) months to assess implementation and impact of CTM.

Being tested
Choose to Move
Keywords
Older adults, Physical activity, Mobility, Social isolation, Loneliness, Social connectedness, Behavior change, Implementation, Scale-up, Health equity
Medical subject headings
Sedentary Behavior, Mobility Limitation, 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 MoveBehavioural

    As described under study arm description

Study groups in NCT06434298
Study groupRoleWhat they receive
Choose to MoveExperimentalCTM (Phase 4) is a 3-month, flexible, choice-based health-promoting program for low active older adults. CTM includes: 1-on-1 Consultation: Participants meet 1-on-1 with their activity coach at the start of the program to set goals and develop a physical activity action plan tailored to their abilities, interests and resources. Older adults can choose to participate in individual or group-based activities. Group Meetings: Participants will attend eight, 1-hour group-based meetings (max of 15 participants) led by an activity coach. Meetings cover a health-related discussion topic and provide time for social connection among participants. Meetings can be held online or in-person. Community-based seniors' services organizations that deliver CTM may adapt the program (e.g., deliver in a different language, adapt for cultural or geographical factors) to fit the needs of the older adults they serve but the two components listed above will be retained.
Receives: Behavioral: Choose to Move

What is being measured

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

  1. Change in physical activity

    The single item physical activity questionnaire will be used to measure physical activity. Output variable is self-reported number of days/week ≥30 min physical activity in the past week (range 0-7).

    Measured: 0, 3 months

Secondary outcomes (8)

  1. Change in capacity for mobility

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

    Measured: 0, 3 months

  2. Change in physical functioning

    The Physical Functioning Subscale of the SF-36 will be used to assess the physical function aspect of mobility. The measure asks participants to rate if their health limits them in performing 10 different activities. The output variable is an average score (range 0-100) of physical functioning, where a higher score indicates a more favourable health state.

    Measured: 0, 3 months

  3. Change in loneliness

    The three-item loneliness scale will be used to assess loneliness. Participants rate three aspects of loneliness. The output variable is loneliness score (range 3-9); lower scores indicate lower levels of loneliness.

    Measured: 0, 3 months

  4. Change in social isolation

    A four-item questionnaire adapted from two questions on social contact frequency will be used to assess social isolation. The output variable is social isolation score (range 0-20); higher scores indicate lower levels of social isolation.

    Measured: 0, 3 months

  5. Change in social network

    A six-item questionnaire will be used to assess social network. The output variable is an equally weighted sum (range 0-30) where higher scores indicate more social engagement.

    Measured: 0, 3 months

  6. Change in social connectedness

    A single item will be used to assess sense of belonging as an indicator of social connectedness. The output variable is sense of belonging score (range 1-4) where lower scores indicate a stronger sense of belonging.

    Measured: 0, 3 months

  7. Change in bone/muscle-strengthening physical activity

    A single item will be used to assess frequency (days/week) of activities that increase bone and/or muscle strength.

    Measured: 0, 3 months

  8. Change in balance-enhancing physical activity

    A single item will be used to assess frequency (days/week) of activities that improve balance.

    Measured: 0, 3 months

Timeline

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

  1. First posted30 May 2024
  2. Study start1 Sep 2023
  3. Primary completion30 Aug 2026 (estimated)
  4. Study completion30 Aug 2027 (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
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5,720 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06434298
Sponsor's protocol ID
H23-02336
Status last verified
Jun 2024
First submitted
23 May 2024
Last updated
6 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.

    PubMed 22310560

  • 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

  • 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

  • Macdonald HM, Nettlefold L, Bauman A, Sims-Gould J, McKay HA. Pragmatic Evaluation of Older Adults' Physical Activity in Scale-Up Studies: Is the Single-Item Measure a Reasonable Option? J Aging Phys Act. 2022 Feb 1;30(1):25-32. doi: 10.1123/japa.2020-0412. Epub 2021 Aug 4.

    PubMed 34348228

  • 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

  • Veroff JB. The dynamics of help-seeking in men and women: a national survey study. Psychiatry. 1981 Aug;44(3):189-200.

    PubMed 7267859

  • Bauer GR, Braimoh J, Scheim AI, Dharma C. Transgender-inclusive measures of sex/gender for population surveys: Mixed-methods evaluation and recommendations. PLoS One. 2017 May 25;12(5):e0178043. doi: 10.1371/journal.pone.0178043. eCollection 2017.

    PubMed 28542498

  • Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

    PubMed 1593914

  • 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

  • McKay H, Naylor PJ, Lau E, Gray SM, Wolfenden L, Milat A, Bauman A, Race D, Nettlefold L, Sims-Gould J. Implementation and scale-up of physical activity and behavioural nutrition interventions: an evaluation roadmap. Int J Behav Nutr Phys Act. 2019 Nov 7;16(1):102. doi: 10.1186/s12966-019-0868-4.

    PubMed 31699095

  • 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

  • Subedi R, Aitken N, Greenberg L. Canadian Social Environment Typology User Guide. Ottawa, ON: Statistics Canada; 2022. Available at: https://www150.statcan.gc.ca/n1/pub/17-20-0002/172000022022002-eng.htm

Questions about this trial

What is this clinical trial studying?

A study testing Choose to Move in people with Aging and Physical Inactivity, 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 1 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: enrolling by invitation, as of the sponsor's last update on 6 Jun 2024. 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?

This study is still under way. Results are not available in the source record yet.

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 physical activity (time frame: 0, 3 months). 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 NCT06434298, which also lists 12 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 6 Jun 2024.

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