## Protocol Section
### Identification Module
**NCT ID:** NCT06434298

**Brief Title:** Continued Evaluation of Choose to Move (CTM) Phase 4

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

#### Organization Study ID Info
**ID:** H23-02336
#### Organization
**Class:** OTHER
**Full Name:** University of British Columbia
### Status Module
#### Completion Date
**Date:** 2027-08-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2026-08-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-09-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** British Columbia Ministry of Health

#### Lead Sponsor

**Class:** OTHER

**Name:** University of British Columbia

#### Responsible Party

**Investigator Affiliation:** University of British Columbia

**Investigator Full Name:** Heather McKay

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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 scale-up, implementation, and impact of CTM Phase 4.

**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.

### Conditions Module

**Conditions:**

- Aging

- Physical Inactivity

- Mobility Limitation

- Loneliness

- Social Isolation

**Keywords:**

- Older adults

- Physical activity

- Mobility

- Social isolation

- Loneliness

- Social connectedness

- Behavior change

- Implementation

- Scale-up

- Health equity

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 5720

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** CTM (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.

**Intervention Names:**

- Behavioral: Choose to Move

**Label:** Choose to Move

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Choose to Move

**Description:** As described under study arm description

**Name:** Choose to Move

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**Description:** Number of organizations and older adults participating in adapted CTM programs will be obtained from program records.

**Measure:** Reach-individual

**Time Frame:** 3 months

**Description:** The neighbourhood characteristics of the regions where CTM programs were delivered will be determined using the Canadian Social Environment Topology (CanSET) tool.

**Measure:** Reach-regional

**Time Frame:** 3 months

**Description:** Number of activity coaches trained to deliver the CTM program will be obtained from program records.

**Measure:** Adoption - CTM program

**Time Frame:** 3 months

**Description:** Number of group meetings (0-8) delivered by activity coaches will be assessed by survey (developed in house).

**Measure:** Dose delivered - CTM program (survey)

**Time Frame:** 3 months

**Description:** Fidelity to planned delivery will be assessed via survey (designed in house) for activity coaches and older adult participants. Higher scores (1-5 Likert scale) indicate better adherence to planned delivery.

**Measure:** Fidelity - CTM program (survey)

**Time Frame:** 3 months

**Description:** Program satisfaction will be assessed via participant (older adults) survey (designed in house). Higher scores (1-5 Likert scale) indicate higher participant satisfaction with the intervention.

**Measure:** Participant Responsiveness - CTM program (survey)

**Time Frame:** 3 months

**Description:** Program delivery costs will be recorded using a cost capture template developed in house.

**Measure:** Cost

**Time Frame:** 0, 3 months

**Description:** Adaptations or modifications to the Choose to Move program include any additions, deletions, substitutions, repetitions, etc will be assessed by survey (developed in house).

**Measure:** Adaptation - CTM program (survey)

**Time Frame:** 3 months

#### Primary Outcomes

**Description:** 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).

**Measure:** Change in physical activity

**Time Frame:** 0, 3 months

#### Secondary Outcomes

**Description:** 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).

**Measure:** Change in capacity for mobility

**Time Frame:** 0, 3 months

**Description:** 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.

**Measure:** Change in physical functioning

**Time Frame:** 0, 3 months

**Description:** 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.

**Measure:** Change in loneliness

**Time Frame:** 0, 3 months

**Description:** 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.

**Measure:** Change in social isolation

**Time Frame:** 0, 3 months

**Description:** 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.

**Measure:** Change in social network

**Time Frame:** 0, 3 months

**Description:** 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.

**Measure:** Change in social connectedness

**Time Frame:** 0, 3 months

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

**Measure:** Change in bone/muscle-strengthening physical activity

**Time Frame:** 0, 3 months

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

**Measure:** Change in balance-enhancing physical activity

**Time Frame:** 0, 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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.

Exclusion Criteria:

* None

**Healthy Volunteers:** True

**Minimum Age:** 50 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Vancouver

**Country:** Canada

**Facility:** Centre for Hip Health and Mobility, Robert H.N. Ho Research Centre, University of British Columbia

**State:** British Columbia

**Zip:** V5Z 1M9

#### Overall Officials

**Official 1:**

**Affiliation:** University of British Columbia

**Name:** Heather A McKay, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** University of British Columbia

**Name:** Joanie Sims Gould, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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.

**PMID:** 22310560

**Citation:** 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.

**PMID:** 20484314

**Citation:** 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.

**PMID:** 18504506

**Citation:** 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.

**PMID:** 34348228

**Citation:** 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.

**PMID:** 18772472

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

**PMID:** 7267859

**Citation:** 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.

**PMID:** 28542498

**Citation:** 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.

**PMID:** 1593914

**Citation:** 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.

**PMID:** 20957426

**Citation:** 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.

**PMID:** 31699095

**Citation:** 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.

**PMID:** 18322790

**Citation:** 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

#### See Also Links

**Label:** Choose to Move website

**URL:** http://choosetomove.ca

**Label:** Active Aging Research Team website

**URL:** http://activeagingrt.ca

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M26689

- Name: Mobility Limitation

- Relevance: HIGH

- As Found: Mobility Limitation

### Condition Browse Module - Meshes

- ID: D000051346

- Term: Mobility Limitation

### Misc Info Module

- Version Holder: 2024-05-31
