Healthy Eating and Active Living (HEAL), Exploring Feasibility of a Lifestyle Intervention

Lifestyle‐related disorders, including metabolic dysfunction, mental health conditions,and neurodegenerative processes, are increasingly recognized as multifactorial in origin,involving complex interactions between behavior, physiology, and environmental exposures.Interventions targeting diet, physical activity, and behavioral patterns have shownpromise in improving these outcomes. However, despite growing evidence for theireffectiveness, the implementation of comprehensive lifestyle interventions in real‐worldsettings remains limited. Many studies focus on efficacy under controlled conditions butprovide insufficient detail on feasibility, adherence, intervention fidelity, andoperational demands, all of which are critical for translation into scalable models.The Healthy Eating and Active Living (HEAL) study was developed as a translational,multidisciplinary lifestyle intervention embedded within a university researchenvironment. The primary aim of the study is not to evaluate clinical efficacy, but todetermine whether a structured, multimodal intervention can be delivered with sufficientfeasibility, adherence, and operational fidelity to justify progression to larger trialsand clinical applications.This study is designed as a prospective, single‐arm feasibility trial conducted over 12weeks. The intervention integrates supervised progressive resistance training withstructured nutritional guidance and incorporates a comprehensive, multimodal assessmentbattery. The program is delivered using existing institutional infrastructure, includingthe Center for Brain and Health (CBH), the Public Health Research Center (PHRC), the CoreTechnologies Platform (CTP), and on‐campus fitness facilities. This setting allowsevaluation of the intervention under conditions that reflect real‐world implementation,rather than highly controlled laboratory environments.A central design feature of HEAL is the deliberate standardization of its core componentsto ensure reproducibility and scalability. The exercise component consists of supervised,machine‐based resistance training performed twice weekly in 60‐minute sessions. Eachsession follows a fixed sequence of exercises targeting major muscle groups, includingleg press, chest press, seated row, glute drive, lat pulldown, walking lunges, and a coreexercise. Following a brief familiarization phase, progression is guided by predefinedoverload criteria, requiring incremental increases in resistance when participants areable to complete target repetitions with correct form. This standardized structureminimizes variability in delivery, facilitates monitoring of adherence and fidelity, andsupports consistent implementation across participants.The nutritional component is designed to combine structured support with gradualtransition to self‐management. During the initial four weeks, participants receiveprepared meals five days per week, tailored to individual maintenance energy requirementscalculated using established predictive equations. Meals follow a standardizedmacronutrient distribution and emphasize minimally processed, nutrient‐dense foods withhigh dietary fiber content. Participants select meals from a predefined menu, ensuringboth adherence to nutritional targets and individual preference. Following themeal‐provision phase, participants are guided to maintain similar dietary patternsindependently for the remaining eight weeks. Dietary intake is monitored using Intake24,an online 24‐hour dietary recall system, administered at baseline, post‐intervention, andfollow‐up.To evaluate feasibility and the operational burden of integrating diverse outcomemeasures, the study incorporates a comprehensive multimodal assessment battery.Assessments are conducted at baseline (prior to the intervention), immediatelypost‐intervention, and at a 12‐week follow‐up period. Physiological measures includeanthropometry and body composition analysis using bioelectrical impedance. Blood samplesare collected to assess metabolic, inflammatory, and lipid biomarkers. Stool samples areobtained for metagenomic analysis of the gut microbiome. Physical fitness is evaluatedusing a standardized battery including cardiovascular, strength, mobility, and stabilitytests. Objective activity and sleep data are collected using a wrist‐worn wearable deviceover an eight‐day period. Participants also complete validated self‐report questionnairesassessing sleep, wellbeing, energy levels, and daily activity patterns. In addition,resting‐state functional magnetic resonance imaging (fMRI) is performed to assess brainnetwork connectivity and to evaluate the feasibility of incorporating neuroimaging withina lifestyle intervention.The primary outcomes of this study relate to feasibility rather than clinicaleffectiveness. These include recruitment rates, retention across the intervention period,adherence to supervised exercise sessions, fidelity to the prescribed progressionprotocol, adherence to nutritional guidance, participant acceptability, safety, andcompletion rates for each component of the assessment battery. Safety is monitoredcontinuously, with documentation of adverse events, including musculoskeletal complaintsor nutrition‐related issues. Acceptability is assessed qualitatively through participantfeedback regarding burden and overall experience.Secondary outcomes are exploratory and include descriptive changes in physiological,behavioral, and neuroimaging measures across timepoints. These analyses are not intendedto establish efficacy but to identify potential signals, inform outcome selection, andsupport sample size estimation for future studies.The HEAL study also serves as a foundational model for subsequent applications of theintervention framework. In particular, it informs the development of the HEAL‐MS program,which adapts the intervention for individuals with multiple sclerosis within a clinicalcontext. By establishing that the intervention can be delivered with high adherence,acceptable participant burden, and operational feasibility, this study provides essentialimplementation data to guide future translational and clinical research.In summary, the HEAL study is designed to address a key gap in lifestyle interventionresearch by focusing on feasibility, implementation, and scalability within a real‐worldsetting. The integration of standardized intervention components with a comprehensivemultimodal assessment framework allows evaluation not only of participant engagement butalso of the logistical and operational requirements necessary for broader application.Findings from this study will inform the refinement of the intervention protocol andsupport progression to larger‐scale trials and clinical populations.