Study protocol for the randomized controlled trial of EMBOLDEN: a multifaceted intervention aimed at Enhancing physical and community Mobility in older adults with health inequities using community co-design

Rebecca Ganann^1,2*Stuart Phillips³Sarah Neil-Sztramko^4,5Kathryn Fisher^1,2Elizabeth Alvarez⁵Ayse Kuspinar⁶K Bruce Newbold⁷Caroline Moore^1,2Maggie Macneil^1,2Heather Keller⁸Kylie Teggart^1,2Lehana Thabane⁵Gina Agarwal⁹Diana Sherifali¹Janet Adams¹⁰Aref Alshaikhahmed¹⁰

• ¹School of Nursing, Faculty of Health Sciences, McMaster University, Hamilton, Canada
• ²Aging, Community and Health Research Unit, School of Nursing, Faculty of Health Sciences, McMaster University, Hamilton, Canada
• ³Department of Kinesiology, Faculty of Science, McMaster University, Hamilton, Canada
• ⁴National Collaborating Centre for Methods and Tools, School of Nursing, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada
• ⁵Department of Health Research Methodology, Evidence and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Canada
• ⁶Department of Rehabilitation Sciences, Faculty of Health Sciences, McMaster University, Hamilton, Canada
• ⁷School of Earth, Environment and Society, Faculty of Science, McMaster University, Hamilton, Ontario, Canada
• ⁸Department of Kinesiology, Faculty of Applied Health Sciences, University of Waterloo, Waterloo, Ontario, Canada
• ⁹Department of Family Medicine, Faculty of Health Sciences, McMaster University, Hamilton, Canada
• ¹⁰Member of Strategic Guiding Council, Resident of Hamilton, McMaster University, Hamilton, Canada

Background: Reduced physical mobility is common in older adults and is associated with adverse outcomes, including functional decline, depression, social isolation, and poor nutritional status. Group-based programs focusing on physical activity and nutrition to support healthier lifestyles have demonstrated benefits, particularly when paired with social engagement activities. This paper presents the protocol for a randomized controlled trial (RCT) to test a lifestyle intervention called EMBOLDEN: Enhancing physical and community Mobility in older adults with health inequities using community co-design. EMBOLDEN is a co-designed 3-month intervention to improve quality of life by incorporating physical activity, healthy eating, social participation, and system navigation. Participants receiving the EMBOLDEN intervention plus usual care are expected to show improvement in physical activity and other health outcomes compared to receiving usual care alone.Methods: This is a 2-arm Type II hybrid effectiveness-implementation pragmatic RCT. Eligibility criteria include older adults (55+ years), community-dwelling in urban neighbourhoods facing health inequities, able to speak or understand English or Mandarin (or access to family/friend interpreters), and able to walk 10 meters unassisted by another person (assistive devices permitted). Participants will be randomized to the intervention or control arm (1:1 ratio). The intervention arm is usual care plus: 1) 12 weekly group-based sessions to increase knowledge/skills and behaviour activation related to physical activity, healthy eating, fostering social connections and community resources; and 2) up to three tailored individual system navigation sessions. The control arm is usual care, in which participants identify and access services without research support. The primary outcome is time spent doing moderate-to-vigorous physical activity. Secondary outcomes will also be explored, including quality of life, life space mobility, depressive symptoms, nutritional risk, and loneliness. Data will be collected at baseline, 3 months (post-intervention) and 6 months. Mixed effects models will be used to analyze outcomes, intention-to-treat analysis will be employed, and multiple imputation will address missing data. Descriptive and qualitative data from participants, interventionists, and research documentation will be used to examine adaptations and implementation barriers/facilitators. Discussion: A community-based, co-designed lifestyle intervention may improve physical activity and other health outcomes in older adults living in neighbourhoods with health inequities.