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AgingCTMNCT05497648

Evaluating Impact and Implementation of Choose to Move (Phase 3)

A study testing Choose to Move in people with Aging and Physical Inactivity, 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

The objectives of this study are to 1) evaluate whether Choose to Move (CTM) improves health outcomes in older adults who participate and 2) assess whether CTM is delivered as planned and what factors support or inhibit delivery at scale. Read more about this study

Who is it for?
Ages 60 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
1,216 participants
Where
1 siteCanada
Study dates
16 Jan 2018to 25 May 2021
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

  • ≥60 years of age,
  • demonstrate readiness for physical activity via the PAR-Q+ questionnaire (Warburton et al 2011), Get Active Questionnaire (Canadian Society for Exercise Physiology 2017) or a letter of recommendation from their physician
  • <150 min/week physical activity
  • English speaking
  • Activity coaches will be English speaking BCRPA Registered Older Adult Fitness Leaders or Kinesiologists who are delivering CTM at participating centres
  • Recreation Managers and Coordinators affiliated with participating centres delivering CTM
  • Provincial Partners (e.g., individuals/partners who make strategic and/or policy decisions) at partner organizations delivering Choose to Move

Who cannot join

  • previous participation in CTM

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre for Hip Health and Mobility

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

Official title: Choose to Move: Impact and Implementation Evaluation of a Program to Enhance Older Adult Physical Activity, Mobility and Health

The objectives of this study are to 1) evaluate whether Choose to Move (CTM) improves health outcomes in older adults who participate and 2) assess whether CTM is delivered as planned and what factors support or inhibit delivery at scale.

CTM is a 6 month, choice-based program for low active older adults being scaled-up across British Columbia, Canada. The goals of CTM are to enhance physical activity, mobility and social connectedness in older adults living in British Columbia, Canada.

Read the detailed description

CTM is a 6 month, choice-based program for low active older adults being scaled-up in phases across British Columbia, Canada. Within CTM (phase 3), trained activity coaches support older adults in three 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 a series of group meetings with small groups of participants. Finally, activity coaches regularly check in with participants to provide ongoing support. Activity coaches and recreation departments across BC are trained and provided with resources to deliver CTM.

Objectives:

  1. To assess the impact (effectiveness) of CTM (phase 3) delivered at scale on the physical activity, mobility and social connectedness of older adults (Part I - Impact Evaluation)
  2. To assess whether the program was implemented as planned (fidelity) and investigate factors that support or inhibit implementation at scale (Part II - Implementation Evaluation).

Study Design:

We use a hybrid type 2 effectiveness-implementation (Curran et al 2012) pre-post study design to evaluate CTM. We use mixed-methods (quantitative and qualitative) and collect data at 0 (baseline), 3 (mid-intervention), 6 (post-intervention) and 18 (12-months post-intervention) months to assess effectiveness and implementation of CTM.

Being tested
Choose to Move
Keywords
implementation science, scale-up, behaviour change, physical activity, mobility, loneliness, social connectedness, social isolation, older adults, fidelity, adaptation
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

    Also called CTM

    CTM (phase 3) is a 6-month, flexible, evidence- and choice-based program for low active older adults.

    CTM includes

    • One-on-One Consultation Participants meet 1-on-1 with their activity coach at the start of the program to set goals and develop an action plan tailored to their abilities, interests and resources. Older adults can choose to participate in individual or group-based activities.
    • Group Meetings Over the first three months, participants will attend five, 1-hour group-based meetings (up to 12 participants total) led by their activity coach. Meetings cover a discussion topic and provide time and space for social connection between participants.
    • Check-ins Over the six month program, activity coaches will provide six brief telephone check-ins (approximately 15 minutes each and once/month) to discuss their Action Plan and ask questions.
Study groups in NCT05497648
Study groupRoleWhat they receive
Choose to MoveExperimentalIndividuals responsible for delivering Choose to Move and older adults enrolled in Choose to Move
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 (Milton, Bull \& Bauman, 2011). Output variable is self-reported number of days/week ≥30 min PA in the past week.

    Measured: 0, 3, 6, 18-months

Secondary outcomes (13)

  1. 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 (range 3-9); lower scores indicate lower levels of loneliness.

    Measured: 0, 3, 6, 18-months

  2. Change in social isolation

    We assessed social isolation using a three-item questionnaire adapted from two questions on social contact frequency (Veroff et al 1981). The output variable is social isolation score (range 0-15); higher scores indicate less social isolation.

    Measured: 0, 3, 6, 18-months

  3. Change in physical functioning

    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.

    Measured: 0, 3, 6, 18-months

  4. Change in physical activity (PAAQ)

    The Physical Activity Adult Questionnaire will be used to assess physical activity over the previous 7 days (Garriguet et al 2015). Output variable is minutes of PA/week.

    Measured: 0, 3, 6, 18-months

  5. Change in health-related quality of life (EQ-5D-5L Profile)

    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.

    Measured: 0, 3, 6, 18-months

  6. Change in health-related quality of life (EQ-5D-5L Level Sum Score)

    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).

    Measured: 0, 3, 6, 18-months

  7. Change in health-related quality of life (EQ-5D-5L Visual Analogue Scale)

    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).

    Measured: 0, 3, 6, 18-months

  8. 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).

    Measured: 0, 3, 6, 18-months

  9. 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

    Measured: 0, 3, 6, 18-months

  10. Change in social network

    We use a six-item questionnaire (Lubben et al., 2006) to assess social isolation. The output variable is an equally weighted sum (range 0-30).

    Measured: 0, 3, 6, 18-months

  11. Change in grip strength (subset)

    We assess grip strength using a hand grip dynamometer and standard protocols. We combine the best trial from each side and report the sum as total grip strength.

    Measured: 0, 3, 6, 18-months

  12. Change in lower extremity function (subset)

    We use the short performance physical battery (SPPB) to assess lower extremity functioning (Guralnik et al 1994). The output variable is an equally weighted sum of 3 subscores (range 0-12); higher scores represent better performance.

    Measured: 0, 3, 6, 18-months

  13. Change in physical activity (CHAMPS)

    We use the CHAMPS questionnaire (Stewart et al 2001) to assess weekly frequency and duration of a variety of physical activities and use the CHAMPS scoring algorithms to calculate energy expenditure (kcal/week) and frequency (times/week).

    Measured: 0, 3, 6, 18-months

Timeline

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

  1. First posted11 Aug 2022
  2. Study start16 Jan 2018
  3. Primary completion25 May 2021
  4. Study completion25 May 2021

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
1,216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05497648
Sponsor's protocol ID
H15-02522
Other IDs
PJT-153248
Acronym
CTM
Status last verified
Aug 2022
First submitted
5 Aug 2022
Last updated
22 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Canadian Society for Exercise Physiology. Get Active Questionnaire. 2017. Available: https://csep.ca/wp-content/uploads/2021/05/GETACTIVEQUESTIONNAIRE_ENG.pdf

  • 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

  • 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

  • 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

  • Garriguet D, Tremblay S, Colley RC. Comparison of Physical Activity Adult Questionnaire results with accelerometer data. Health Rep. 2015 Jul;26(7):11-7.

    PubMed 26177042

  • Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.

    PubMed 8126356

  • 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

  • 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

  • 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

  • Milton K, Clemes S, Bull F. Can a single question provide an accurate measure of physical activity? Br J Sports Med. 2013 Jan;47(1):44-8. doi: 10.1136/bjsports-2011-090899. Epub 2012 Apr 20.

    PubMed 22522584

  • 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

  • Stewart AL, Mills KM, King AC, Haskell WL, Gillis D, Ritter PL. CHAMPS physical activity questionnaire for older adults: outcomes for interventions. Med Sci Sports Exerc. 2001 Jul;33(7):1126-41. doi: 10.1097/00005768-200107000-00010.

    PubMed 11445760

  • Veroff, J.; Kulka, R. A.; Douvan, E. Mental health in America: Patterns of help-seeking from 1957-1976. Basic Books: New York, 1981.

  • Warburton DE, Jamnik VK, Bredin SSD, Gledhill N, on behalf of the PAR-Q+ Collaboration. The Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) and Electronic Physical Activity Readiness Medical Examination (ePARmed-X+). Health & Fitness Journal of Canada. 2011;4(2):3-23.

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 7 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: finished, as of the sponsor's last update on 22 Aug 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?

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 physical activity (time frame: 0, 3, 6, 18-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 NCT05497648, which also lists 17 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 22 Aug 2022.

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