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

Not Applicable

Active, not recruiting

• Conditions: Aging; Mobility Limitation; Loneliness; Social Isolation; Sedentary Behavior
• Interventions: Behavioral: Choose to Move - Next Steps

• Registration Number: NCT04592614
• Lead Sponsor: University of British Columbia

Brief 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. 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.

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.

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-10-16
• Study First Posted: 2020-10-19
• Study Start: 2020-12-07
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-15
• Last Update Posted: 2023-12-18
• Primary Completion: 2024-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 424

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose	Choose to Move - Next Steps	CTM-NS participants receiving quarterly virtual group meetings for 2 years (8 meetings total)
High dose	Choose to Move - Next Steps	CTM-NS participants receiving monthly virtual group meetings for 2 years (24 meetings total)

Primary Outcome Measures

Name	Time	Method
Change in self-perception of mobility	0, 3, 12, 24 months	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.
Change in mobility limitations	0, 3, 12, 24 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).; Change will be assessed using longitudinal modelling across 0, 3, 12 and 24 months.
Change in physical functioning	0, 3, 12, 24 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in loneliness	0, 3, 12, 24 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 (3-9); lower scores indicate lower levels of loneliness.; Change will be assessed using longitudinal modelling across 0, 3, 12 and 24 months.
Change in social isolation	0, 3, 12, 24 months	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.
Change in physical activity	0, 3, 12, 24 months	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.
Change in health status (EQ-5D-5L Level Sum Score)	0, 3, 12, 24 months	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.
Change in social connectedness	0, 3, 12, 24 months	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.
Change in health status (EQ-5D-5L Visual Analogue Scale)	0, 3, 12, 24 months	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.
Change in social network	0, 3, 12, 24 months	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.
Change in sitting time	0, 3, 12, 24 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.; Change will be assessed using longitudinal modelling across 0, 3, 12 and 24 months.
Change in screen time	0, 3, 12, 24 months	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.
Change in health status (EQ-5D-5L Profile)	0, 3, 12, 24 months	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.

Trial Locations

Locations (1)

Centre for Hip Health and Mobility, Robert H.N. Ho Research Centre, University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada