COMPASS 65+ - Community-based Physical Activity Snacks for Healthy Aging in Overweight and Obese Aged Adults

Study Rationale and Background The intersection of an aging population and the obesity epidemic poses a significant public health challenge, particularly for adults aged 65 and older. This combination often leads to sarcopenic obesity, a condition characterized by excess body fat and low muscle mass and strength, which substantially increases the risk of falls, frailty, functional decline, and loss of independence. While physical activity is a proven non-pharmacological intervention to counteract these declines, adherence to traditional, structured exercise programs remains low among older adults. Barriers such as a perceived lack of time, low motivation, and fatigue create a gap between the known benefits of exercise and its practical implementation in real-world community settings.

This study, COMPASS 65+, proposes to evaluate an innovative exercise modality known as "snack exercise." This approach involves short, frequent bouts of physical activity performed throughout the day, designed to be more accessible and less burdensome than conventional exercise routines. The primary aim of this project is to assess the feasibility, acceptability, and preliminary effects of a community-based "snack exercise" program, co-designed with input from the target population, for overweight and obese older adults. The findings are intended to provide the necessary evidence to design a future, definitive large-scale randomized controlled trial (RCT).

Study Design

The research plan is structured in two sequential phases:

1. Phase 1: Exploratory Mixed-Methods Study This initial phase is designed to inform the development of the intervention. It involves a mixed-methods approach to identify barriers, facilitators, and preferences related to physical activity among the target population.

* Quantitative Component: A cross-sectional survey will be administered to a convenience sample of 370 adults aged 65 or older with a Body Mass Index (BMI) of 25 kg/m² or greater. The survey will include validated instruments such as the Exercise Benefits/Barriers Scale (EBBS) and the Multimorbidity Treatment Burden Questionnaire (MTBQ). * Qualitative Component: Focus groups will be conducted with a randomly selected subset of the target population to explore user preferences for program design.The data will be integrated to co-design a "snack exercise" intervention that is evidence-based and tailored to user needs. 2. Phase 2: Feasibility Randomized Controlled Trial (RCT) A two-arm, parallel-group feasibility RCT will be conducted to test the co-designed intervention.

* Participants: A target of 60 participants will be recruited from primary care settings. Inclusion criteria include adults aged ≥ 65 years with a BMI ≥ 25 kg/m². Exclusion criteria include significant cognitive deficits, contraindications to exercise (assessed via PAR-Q+), major cardiovascular events within the last 3 months, unstable chronic disease, or severe mobility impairment. * Randomization: Participants will be randomly allocated (1:1) to either the intervention group or the control group. * Timeline: The intervention lasts 12 weeks, followed by a 6-week post-intervention "washout" period. Assessments occur at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks). * Intervention Groups Active Comparator (Control Group): Participants will receive a single, standardized Brief Educational Counselling Session (60 minutes) at baseline (T0). Delivered by trained research personnel, this session provides foundational information on the benefits of physical activity for healthy aging and offers practical strategies for incorporating short "physical activity snacks" into daily routines. This ensures a consistent educational baseline.

Experimental Group ("Snack Exercise"): Participants will receive the standardized Brief Educational Counselling Session at baseline, followed by the Structured Community-based Physical Activity Snack Intervention. This program consists of group-based, theoretico-practical sessions held 2-3 times per week, each lasting approximately 45 minutes. Sessions are guided by a physical exercise professional and focus on explaining and practicing the prescribed snack exercises. Crucially, at the end of each session, participants are provided with an individualized physical prescription to perform at home. Exercise intensity is monitored using perceived exertion scales (BORG-OMNI), progressing from light to moderate intensity per WHO recommendations.

Study Procedures and Outcome Measures Protocol \& Ethics: The study adheres to SPIRIT guidelines and the Declaration of Helsinki, with Ethics Committee approval and written informed consent required.

Outcomes \& Data Collection: Comprehensive assessments are conducted at T0, T1, and T2 using validated instruments and objective tools:

* Body Composition \& Anthropometrics: Dual-Energy X-ray Absorptiometry (DEXA) for fat/lean mass and bone density; Height, Weight, BMI (kg/m\^2), and Waist Circumference. * Cardiorespiratory Fitness: One-Mile Walk Test to predict aerobic capacity (VO2 max). * Functional Fitness \& Fall Risk: The Short Physical Performance Battery (SPPB) (assessing balance, gait speed, and chair stands) and the 30-second Chair Stand Test (muscular endurance). * Stability: Limits of stability assessed via a force platform (Physiosensing®). * Daily Physical Activity: Objectively measured using a Fitband worn for five consecutive days (step count, active minutes). * Psychosocial \& Health Status: Exercise Self-Efficacy Scale (ESES). * Multidimensional Lifestyle and Health Status (assessed via the Healthy Lifestyle Assessment Toolkit, covering cardiometabolic health, well-being, nutrition, mental health, and sleep).

Statistical Analysis Plan Primary Analysis (Feasibility): Descriptive analysis of recruitment, adherence, retention, and protocol fidelity based on the RE-AIM framework.

Secondary Analysis (Preliminary Effects): Repeated measures ANOVA or mixed models will be used to assess changes over time (T0, T1, T2) and between groups (p\< 0.05). The goal is to estimate effect sizes to power a future definitive trial.

Data Management: All analyses will be conducted using SPSS (Version 29), with appropriate handling of missing data (e.g., multiple imputation).

• Multidimensional Lifestyle and Health Status [Time frame: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).]
• Daily Physical Activity Patterns [Time frame: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).]
• Body Composition - Dual-Energy X-ray Absorptiometry (DEXA) [Time frame: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).]
• Anthropometrics - Height [Time frame: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).]
• Anthropometrics - Weight [Time frame: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).]
• Anthropometrics - Body Mass Index (BMI) [Time frame: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).]
• Anthropometrics - Waist circumference [Time frame: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).]
• Cardiorespiratory Fitness [Time frame: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).]
• Functional Fitness (muscular endurance) [Time frame: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).]
• Functional Fitness and Fall risk - Short Physical Performance Battery (SPPB) [Time frame: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).]
• Fall Risk and Functional stability (force platform) [Time frame: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).]
• Exercise Self-Efficacy (ESES) [Time frame: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).]