Clinical trial NCT05497648: Evaluating Impact and Implementation of Choose to Move (Phase 3)
Official title: Choose to Move: Impact and Implementation Evaluation of a Program to Enhance Older Adult Physical Activity, Mobility and Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Physical Inactivity
Mobility Limitation
Loneliness
Social Isolation
Keywords: implementation science
scale-up
behaviour change
physical activity
mobility
loneliness
social connectedness
social isolation
older adults
fidelity
adaptation
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Active Aging Society
First posted: 2022-08-11
Enrollment: 1216
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in physical activity
timeFrame: 0, 3, 6, 18-months
Secondary outcomes:
measure: Change in loneliness
timeFrame: 0, 3, 6, 18-months
measure: Change in social isolation
timeFrame: 0, 3, 6, 18-months
measure: Change in physical functioning
timeFrame: 0, 3, 6, 18-months
measure: Change in physical activity (PAAQ)
timeFrame: 0, 3, 6, 18-months
measure: Change in health-related quality of life (EQ-5D-5L Profile)
timeFrame: 0, 3, 6, 18-months
measure: Change in health-related quality of life (EQ-5D-5L Level Sum Score)
timeFrame: 0, 3, 6, 18-months
measure: Change in health-related quality of life (EQ-5D-5L Visual Analogue Scale)
timeFrame: 0, 3, 6, 18-months
measure: Change in mobility limitations
timeFrame: 0, 3, 6, 18-months
measure: Change In sitting time
timeFrame: 0, 3, 6, 18-months
measure: Change in social network
timeFrame: 0, 3, 6, 18-months
measure: Change in grip strength (subset)
timeFrame: 0, 3, 6, 18-months
measure: Change in lower extremity function (subset)
timeFrame: 0, 3, 6, 18-months
measure: Change in physical activity (CHAMPS)
timeFrame: 0, 3, 6, 18-months
Other outcomes:
measure: Reach-individual
timeFrame: 6 months
measure: Reach-organizational
timeFrame: 6 months
measure: Dose
timeFrame: 6 months
measure: Fidelity
timeFrame: 6 months
measure: Participant responsiveness
timeFrame: 6 months
measure: Adaptation
timeFrame: 6 months
measure: Contextual factors influencing implementation
timeFrame: 6 months
measure: Cost
timeFrame: 6 months
Locations:
city: Vancouver
country: Canada
facility: Centre for Hip Health and Mobility
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Heather A McKay
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Joanie Sims Gould
role: PRINCIPAL_INVESTIGATOR
affiliation: Ministry of Health, British Columbia
name: Matthew Herman, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sydney
name: Adrian Bauman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Simon Fraser University
name: Dawn Mackey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Karim Miran-Khan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Victoria
name: Patti-Jean Naylor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Waterloo
name: Paul Stolee, PhD
role: PRINCIPAL_INVESTIGATOR
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