- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05497648
Evaluating Impact and Implementation of Choose to Move (Phase 3) (CTM)
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.
Study Overview
Status
Intervention / Treatment
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:
- 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)
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Centre for Hip Health and Mobility
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria (older adults):
- ≥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
Exclusion Criteria (older adults):
- previous participation in CTM
Inclusion Criteria (delivery partners):
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Choose to Move
Individuals responsible for delivering Choose to Move and older adults enrolled in Choose to Move
|
CTM (phase 3) is a 6-month, flexible, evidence- and choice-based program for low active older adults. CTM includes
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in physical activity
Time Frame: 0, 3, 6, 18-months
|
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.
|
0, 3, 6, 18-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in loneliness
Time Frame: 0, 3, 6, 18-months
|
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.
|
0, 3, 6, 18-months
|
|
Change in social isolation
Time Frame: 0, 3, 6, 18-months
|
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.
|
0, 3, 6, 18-months
|
|
Change in physical functioning
Time Frame: 0, 3, 6, 18-months
|
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.
|
0, 3, 6, 18-months
|
|
Change in physical activity (PAAQ)
Time Frame: 0, 3, 6, 18-months
|
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.
|
0, 3, 6, 18-months
|
|
Change in health-related quality of life (EQ-5D-5L Profile)
Time Frame: 0, 3, 6, 18-months
|
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.
|
0, 3, 6, 18-months
|
|
Change in health-related quality of life (EQ-5D-5L Level Sum Score)
Time Frame: 0, 3, 6, 18-months
|
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).
|
0, 3, 6, 18-months
|
|
Change in health-related quality of life (EQ-5D-5L Visual Analogue Scale)
Time Frame: 0, 3, 6, 18-months
|
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).
|
0, 3, 6, 18-months
|
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Change in mobility limitations
Time Frame: 0, 3, 6, 18-months
|
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).
|
0, 3, 6, 18-months
|
|
Change In sitting time
Time Frame: 0, 3, 6, 18-months
|
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
|
0, 3, 6, 18-months
|
|
Change in social network
Time Frame: 0, 3, 6, 18-months
|
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).
|
0, 3, 6, 18-months
|
|
Change in grip strength (subset)
Time Frame: 0, 3, 6, 18-months
|
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.
|
0, 3, 6, 18-months
|
|
Change in lower extremity function (subset)
Time Frame: 0, 3, 6, 18-months
|
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.
|
0, 3, 6, 18-months
|
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Change in physical activity (CHAMPS)
Time Frame: 0, 3, 6, 18-months
|
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).
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0, 3, 6, 18-months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reach-individual
Time Frame: 6 months
|
The number of participants engaged in the intervention is obtained from program records.
|
6 months
|
|
Reach-organizational
Time Frame: 6 months
|
The number of organizations and activity coaches delivering the intervention is obtained from program records.
|
6 months
|
|
Dose
Time Frame: 6 months
|
The amount of intervention delivered is assessed via survey (designed in house)
|
6 months
|
|
Fidelity
Time Frame: 6 months
|
Fidelity to planned delivery is assessed via survey (designed in house) and interview/focus group.
|
6 months
|
|
Participant responsiveness
Time Frame: 6 months
|
We assess program satisfaction via participant survey (designed in house) and interviews.
|
6 months
|
|
Adaptation
Time Frame: 6 months
|
We assess adaptation of the intervention and its delivery via survey (designed in house) and interview/focus groups
|
6 months
|
|
Contextual factors influencing implementation
Time Frame: 6 months
|
We use surveys (designed in house) and interviews/focus groups to describe how community level factors, provider characteristics, characteristics of the innovation, the prevention delivery system, organizational capacity and the prevention support system influenced program delivery.
|
6 months
|
|
Cost
Time Frame: 6 months
|
We use a cost capture template to record program delivery costs.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patti-Jean Naylor, PhD, University of Victoria
- Principal Investigator: Heather A McKay, University of British Columbia
- Principal Investigator: Joanie Sims Gould, University of British Columbia
- Principal Investigator: Matthew Herman, MSc, Ministry of Health, British Columbia
- Principal Investigator: Adrian Bauman, PhD, University of Sydney
- Principal Investigator: Dawn Mackey, PhD, Simon Fraser University
- Principal Investigator: Karim Miran-Khan, PhD, University of British Columbia
- Principal Investigator: Paul Stolee, PhD, University of Waterloo
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Canadian Society for Exercise Physiology. Get Active Questionnaire. 2017. Available: https://csep.ca/wp-content/uploads/2021/05/GETACTIVEQUESTIONNAIRE_ENG.pdf
- Garriguet D, Tremblay S, Colley RC. Comparison of Physical Activity Adult Questionnaire results with accelerometer data. Health Rep. 2015 Jul;26(7):11-7.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H15-02522
- PJT-153248 (Other Grant/Funding Number: Canadian Institutes of Health Research)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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