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A Community-based Program That Supports Physical Activity, Healthy Eating, Social Participation and System Navigation in Older Adults (EMBOLDEN)

Primary Purpose

Mobility Limitation, Health Related Quality of Life, Healthy Aging

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
3 month community-based mobility and health intervention
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mobility Limitation focused on measuring Physical Mobility, Aging, Community-based intervention, Public and community engagement, Physical activity, Healthy eating, Social participation, System navigation, Life-space, Community mobility, Community integration

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

• Community-dwelling older adults (55 years of age and older) living in a neighbourhood selected for the study.

Exclusion criteria:

  • Unable to speak or understand English
  • Unable to walk 10 meters without physical assistance from another person (assistive devices permitted)

As a pragmatic trial, we have chosen broad inclusion criteria to reflect the characteristics of individuals who may join a program such as this outside of a research study. Thus, we will not exclude individuals based on the presence of existing chronic disease, comorbidities, or other factors that may impact attendance.

Sites / Locations

  • CommunityRecruiting
  • Downtown East Community

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The EMBOLDEN program

Usual care

Arm Description

3 month community-based mobility and healthy aging intervention

Outcomes

Primary Outcome Measures

Physical mobility
Change in total weekly minutes spent in light, moderate-to-vigorous physical activity and sedentary activity as measured by an accelerometer worn over 7-day periods.

Secondary Outcome Measures

Community mobility
Change in community mobility as measured by GPS-derived quantity of out of home activities
Life Space mobility
Change in life space mobility as measured by Life Space Index (LSI)which is a self-reported measure of community mobility with strong psychometric properties . Scores range from 0-120, where a score of 120 characterizes the highest possible level of life-space (i.e. going out of town without assistance). A change of 5 to 10 points on the LSI is considered clinically meaningful.
Physical activity
Change in self-reported physical activity as measured by the Physical Activity Scale for the Elderly (PASE). PASE assesses the types of activities typically chosen by older adults (walking, recreational activities, exercise, housework, yard work, and caring for others. It uses frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity.
Healthy eating and nutritional risk
Change in healthy eating and nutritional risk as measured by Seniors in the community: risk evaluation for eating and nutrition, Version II (SCREEN-II). Scores range from 0 to 64. Lower scores on SCREEN II indicate increased risk for impaired nutritional states. Scores <50 indicate high nutrition risk.
Health-related quality of life
Change in health-related quality of life as measured by the 12-Item Short Form Survey (SF-12). Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Health-related quality of life
Change in health-related quality of life as measured by the EQ-5D-5L. Scores range from -0.281 to 1, where values lower than 0 represent states considered to be worse than death. The instrument also includes a visual analogue scale (EQ-VAS) which provides a single global rating of self-perceived health and is scored on a 0 to 100 mm scale representing "the worst…" and "the best health you can imagine", respectively.
Loneliness
Change in loneliness as measured by the 6-item De Jong Gierveld Loneliness scale. The total scale score is the sum of the item scores, ranging from 0 (not lonely) to 11 (extremely lonely). A score of 3 or higher is an indication of loneliness.
Depression
Change in depression as measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 score can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day). Major depression is diagnosed if 5 or more of the 9 depressive symptom criteria have been present at least "more than half the days" in the past 2 weeks, and 1 of the symptoms is depressed mood or anhedonia. Other depression is diagnosed if 2, 3, or 4 depressive symptoms have been present at least "more than half the days" in the past 2 weeks, and 1 of the symptoms is depressed mood or anhedonia. One of the 9 symptom criteria ("thoughts that you would be better off dead or of hurting yourself in some way") counts if present at all, regardless of duration. As with the original PRIME-MD, before making a final diagnosis, the clinician is expected to rule out physical causes of depression, normal bereavement, and history of a manic episode.
Collective efficacy
Change in the process of engaging and sustaining self-management support in everyday settings measured by the Collective Efficacy of Networks questionnaire (CENS). Scores can range from 12-60, with higher scores indicating higher self-management support.
Food security
2 questions validated from the US Department of Agriculture 18-item Household Food Security Survey (HFSS) that identifies risk for food insecurity if the participants answer that either or both of the following two statements is 'often true' or 'sometimes true' (vs. 'never true').
Satisfaction with Participation in Discretionary Social Activities
Change in satisfaction with participation in discretionary social activities measured by Patient-Reported Outcomes Measurement Information System (PROMIS). Scores ranges from 7 to 35. Higher scores represent higher satisfaction with participation in discretionary social activities.
Community Belonging
Change in sense of community belonging measured by social capital at the neighbourhood level. This is 1 question taken from the Canadian Community Health Survey: How would you describe your sense of belonging to your local community? Participants choose one of the following options: Very strong; Somewhat strong; Somewhat weak; Very weak.
Healthcare and social service utilization
Change in number of emergency room visits, number of hospitalizations, number of primary care and specialist visits.

Full Information

First Posted
July 29, 2021
Last Updated
November 22, 2022
Sponsor
McMaster University
Collaborators
The Labarge Centre for Mobility in Aging, Canadian Institutes of Health Research (CIHR), Public Health Agency of Canada (PHAC)
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1. Study Identification

Unique Protocol Identification Number
NCT05008159
Brief Title
A Community-based Program That Supports Physical Activity, Healthy Eating, Social Participation and System Navigation in Older Adults
Acronym
EMBOLDEN
Official Title
The Enhancing Physical and Community Mobility in Older Adults With Health Inequities Using Community Co-design of a Multifaceted Intervention Incorporating Physical Activity, Healthy Eating, Social Participation, and System Navigation (EMBOLDEN) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 27, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
The Labarge Centre for Mobility in Aging, Canadian Institutes of Health Research (CIHR), Public Health Agency of Canada (PHAC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Physical mobility and social participation are needed to maintain independence and quality of life for adults over 55 years of age. Despite the known benefits of physical activity and dietary change programs for older adults, the best ways to deliver these interventions are not well understood. The goal of the EMBOLDEN study is to promote physical and community mobility in older adults who experience difficulties taking up community programs and reside in areas of high health inequity. Building on existing best practices, the investigators will implement and evaluate an innovative co-designed community-based program to promote physical activity, healthy eating, social participation, and system navigation. The potential for spreading this program throughout Hamilton and adapted to other Canadian communities will also be explored
Detailed Description
This is a randomized controlled trial employing a type II hybrid implementation-effectiveness design. This will enable the investigators to evaluate both clinical outcomes and important processes that impact the implementation of the co-designed intervention. The intervention will consist of i) weekly interactive group-based health education sessions focused on: increasing knowledge, skills, and behaviours related to physical activity, healthy eating, and available community supports for older adults; this will include facilitated physical activity delivered by a certified exercise physiologist or certified personal trainer with experience and expertise working with older adults and interactive nutrition sessions; socialization to foster peer and community connections, co-learning, and decrease social isolation; and skill-building to support independence and quality of life; and ii) tailored system navigation support to increase access to and use of health and social services systems and address barriers or unmet needs The investigators will place equal weight on our primary effectiveness outcome (physical mobility) and implementation outcomes: Effectiveness: quantitative, two-arm randomized controlled trial (RCT) using accelerometers and questionnaires completed by study participants at baseline, immediately following the program, and 6 months after baseline to measure primary and secondary effectiveness outcomes. Qualitative interviews will be conducted with interventionists and a subset of participants to explore perceived effectiveness. Implementation: quantitative surveys, document analysis (e.g., meeting notes), and qualitative interviews will be conducted with participants, interventionists, and Community Advisory Board members to evaluate implementation outcomes, and understand implementation barriers and facilitators. This trial has a pragmatic design in the following ways: i) recruiting a population with broad inclusion criteria, reflective of the general population of older adults; ii) conducting the study in existing community settings (when in-person delivery is feasible) and virtually, in partnership with organizations already delivering virtual supports due to the pandemic; iii) leveraging existing resources, staff, and service delivery organizations in the intervention arm that are available in usual care; iv) supporting flexibility delivery of the intervention (e.g., tailoring to participant group needs), as would be done through other community programs in usual care; v) flexibility in adherence to the intervention, in ways that are consistent with usual care; vi) selecting primary and secondary outcomes that are participant-relevant; and vii) using intention to treat analyses based on all available data. Primary Effectiveness Question: Does the 3-month EMBOLDEN intervention increase physical mobility compared to usual care in community-dwelling older adults (55+ years) residing in areas of high health inequity? Primary Implementation Question: How is the EMBOLDEN intervention implemented and adapted across diverse neighbourhoods? The study will be delivered in community settings in nine urban neighbourhoods identified as areas of health inequities (using Statistics Canada census tract data, 2016) in the cities of Hamilton and Toronto, Ontario.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation, Health Related Quality of Life, Healthy Aging, Health Inequity
Keywords
Physical Mobility, Aging, Community-based intervention, Public and community engagement, Physical activity, Healthy eating, Social participation, System navigation, Life-space, Community mobility, Community integration

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Type II hybrid effectiveness-implementation RCT
Masking
InvestigatorOutcomes Assessor
Masking Description
Participants and interventionists are not blinded. All data collectors will be independent of the study and blinded to treatment allocation. Statisticians will be blinded to treatment allocation.
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The EMBOLDEN program
Arm Type
Experimental
Arm Description
3 month community-based mobility and healthy aging intervention
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
3 month community-based mobility and health intervention
Intervention Description
12 weekly GROUP (10-15 adults per cohort) sessions + 3 INDIVIDUAL tailored system navigation sessions at beginning, midpoint, and end of program. The 3-month GROUP program will include the following fixed components: i) weekly interactive group-based health education sessions focused on: increasing knowledge, skills, and behaviours related to physical activity, healthy eating, and available community supports for older adults; socialization to foster peer and community connections, co-learning, and decrease social isolation skill-building to support independence and quality of life; and ii) INDIVIDUAL tailored system navigation support
Primary Outcome Measure Information:
Title
Physical mobility
Description
Change in total weekly minutes spent in light, moderate-to-vigorous physical activity and sedentary activity as measured by an accelerometer worn over 7-day periods.
Time Frame
Between baseline and 3-months. An additional comparison will be made at 6-months to examine whether potential changes are maintained in the post-intervention phase.
Secondary Outcome Measure Information:
Title
Community mobility
Description
Change in community mobility as measured by GPS-derived quantity of out of home activities
Time Frame
Between baseline and 3-months. An additional comparison will be made at 6-months to examine whether potential changes are maintained in the post-intervention phase.
Title
Life Space mobility
Description
Change in life space mobility as measured by Life Space Index (LSI)which is a self-reported measure of community mobility with strong psychometric properties . Scores range from 0-120, where a score of 120 characterizes the highest possible level of life-space (i.e. going out of town without assistance). A change of 5 to 10 points on the LSI is considered clinically meaningful.
Time Frame
Between baseline and 3-months. An additional comparison will be made at 6-months to examine whether potential changes are maintained in the post-intervention phase.
Title
Physical activity
Description
Change in self-reported physical activity as measured by the Physical Activity Scale for the Elderly (PASE). PASE assesses the types of activities typically chosen by older adults (walking, recreational activities, exercise, housework, yard work, and caring for others. It uses frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity.
Time Frame
Between baseline and 3-months. An additional comparison will be made at 6-months to examine whether potential changes are maintained in the post-intervention phase.
Title
Healthy eating and nutritional risk
Description
Change in healthy eating and nutritional risk as measured by Seniors in the community: risk evaluation for eating and nutrition, Version II (SCREEN-II). Scores range from 0 to 64. Lower scores on SCREEN II indicate increased risk for impaired nutritional states. Scores <50 indicate high nutrition risk.
Time Frame
Between baseline and 3-months. An additional comparison will be made at 6-months to examine whether potential changes are maintained in the post-intervention phase.
Title
Health-related quality of life
Description
Change in health-related quality of life as measured by the 12-Item Short Form Survey (SF-12). Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Time Frame
Between baseline and 3-months. An additional comparison will be made at 6-months to examine whether potential changes are maintained in the post-intervention phase.
Title
Health-related quality of life
Description
Change in health-related quality of life as measured by the EQ-5D-5L. Scores range from -0.281 to 1, where values lower than 0 represent states considered to be worse than death. The instrument also includes a visual analogue scale (EQ-VAS) which provides a single global rating of self-perceived health and is scored on a 0 to 100 mm scale representing "the worst…" and "the best health you can imagine", respectively.
Time Frame
Between baseline and 3-months. An additional comparison will be made at 6-months to examine whether potential changes are maintained in the post-intervention phase.
Title
Loneliness
Description
Change in loneliness as measured by the 6-item De Jong Gierveld Loneliness scale. The total scale score is the sum of the item scores, ranging from 0 (not lonely) to 11 (extremely lonely). A score of 3 or higher is an indication of loneliness.
Time Frame
Between baseline and 3-months. An additional comparison will be made at 6-months to examine whether potential changes are maintained in the post-intervention phase.
Title
Depression
Description
Change in depression as measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 score can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day). Major depression is diagnosed if 5 or more of the 9 depressive symptom criteria have been present at least "more than half the days" in the past 2 weeks, and 1 of the symptoms is depressed mood or anhedonia. Other depression is diagnosed if 2, 3, or 4 depressive symptoms have been present at least "more than half the days" in the past 2 weeks, and 1 of the symptoms is depressed mood or anhedonia. One of the 9 symptom criteria ("thoughts that you would be better off dead or of hurting yourself in some way") counts if present at all, regardless of duration. As with the original PRIME-MD, before making a final diagnosis, the clinician is expected to rule out physical causes of depression, normal bereavement, and history of a manic episode.
Time Frame
Between baseline and 3-months. An additional comparison will be made at 6-months to examine whether potential changes are maintained in the post-intervention phase.
Title
Collective efficacy
Description
Change in the process of engaging and sustaining self-management support in everyday settings measured by the Collective Efficacy of Networks questionnaire (CENS). Scores can range from 12-60, with higher scores indicating higher self-management support.
Time Frame
Between baseline and 3-months. An additional comparison will be made at 6-months to examine whether potential changes are maintained in the post-intervention phase.
Title
Food security
Description
2 questions validated from the US Department of Agriculture 18-item Household Food Security Survey (HFSS) that identifies risk for food insecurity if the participants answer that either or both of the following two statements is 'often true' or 'sometimes true' (vs. 'never true').
Time Frame
Between baseline and 3-months. An additional comparison will be made at 6-months to examine whether potential changes are maintained in the post-intervention phase.
Title
Satisfaction with Participation in Discretionary Social Activities
Description
Change in satisfaction with participation in discretionary social activities measured by Patient-Reported Outcomes Measurement Information System (PROMIS). Scores ranges from 7 to 35. Higher scores represent higher satisfaction with participation in discretionary social activities.
Time Frame
Between baseline and 3-months. An additional comparison will be made at 6-months to examine whether potential changes are maintained in the post-intervention phase.
Title
Community Belonging
Description
Change in sense of community belonging measured by social capital at the neighbourhood level. This is 1 question taken from the Canadian Community Health Survey: How would you describe your sense of belonging to your local community? Participants choose one of the following options: Very strong; Somewhat strong; Somewhat weak; Very weak.
Time Frame
Between baseline and 3-months. An additional comparison will be made at 6-months to examine whether potential changes are maintained in the post-intervention phase.
Title
Healthcare and social service utilization
Description
Change in number of emergency room visits, number of hospitalizations, number of primary care and specialist visits.
Time Frame
Between baseline and 3-months. An additional comparison will be made at 6-months to examine whether potential changes are maintained in the post-intervention phase.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: • Community-dwelling older adults (55 years of age and older) living in a neighbourhood selected for the study. Exclusion criteria: Unable to speak or understand English Unable to walk 10 meters without physical assistance from another person (assistive devices permitted) As a pragmatic trial, we have chosen broad inclusion criteria to reflect the characteristics of individuals who may join a program such as this outside of a research study. Thus, we will not exclude individuals based on the presence of existing chronic disease, comorbidities, or other factors that may impact attendance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline J Moore, BSc(Hons)
Phone
905-525-9140
Ext
22305
Email
camoore@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Ganann, RN, PhD
Phone
905-525-9140
Ext
22456
Email
ganann@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Ganann, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community
City
Hamilton
State/Province
Ontario(ON)
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Moore
Phone
9055259140
Ext
22305
Email
camoore@mcmaster.ca
Facility Name
Downtown East Community
City
Toronto
State/Province
Ontario(ON)
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Moore
Phone
9055259140
Ext
22305
Email
camoore@mcmaster.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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A Community-based Program That Supports Physical Activity, Healthy Eating, Social Participation and System Navigation in Older Adults

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