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Completed NCT07662499

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

Conditions: Lifestyle (Sedentary Behavior and Physical Activity), Lifestyle Intervention, Lifestyle Modification

Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 19
Sponsor: New York University Abu Dhabi

Location: New York University Abu Dhabi Abu Dhabi Abu Dhabi Emirate

Summary

Lifestyle interventions combining nutrition, physical activity, and behavioral strategies are increasingly recognized for improving metabolic and psychological health, yet their translation into real-world settings remains limited. Key implementation factors such as feasibility, adherence, intervention fidelity, and the integration of complex assessment modalities are often underreported, despite being essential for scaling and clinical application. The Healthy Eating and Active Living (HEAL) study is a prospective, single-arm feasibility trial evaluating a structured, multimodal lifestyle intervention within a university research environment. The 12-week program integrates supervised progressive resistance training and structured nutritional guidance, delivered through existing infrastructure including the Center for Brain and Health, the Public Health Research Center, on-campus fitness facilities, and digital dietary monitoring tools. The exercise component consists of twice-weekly supervised, machine-based resistance training with standardized progression, while the nutritional component includes four weeks of meal provision followed by guided self-management. Participants complete a multimodal assessment battery at baseline, post-intervention, and 12-week follow-up, including body composition, blood biomarkers, gut microbiome analysis, fitness testing, wearable-based activity and sleep monitoring, self-reported measures, and resting-state functional magnetic resonance imaging (fMRI). The primary objective is to assess feasibility, including recruitment, retention, adherence, intervention fidelity, safety, acceptability, and data completeness. Secondary analyses explore pre-post changes in physiological, behavioral, and neuroimaging outcomes to inform future study design. The study is not powered to assess clinical efficacy. Findings will inform the design of larger trials and the application of the HEAL framework in clinical populations.

Eligibility Criteria

Inclusion Criteria: * Adults aged 18 to 65 years * Able to participate in moderate-intensity supervised resistance training * Willing to comply with the 12-week intervention and associated assessments * Able to provide biological samples (blood and stool) and complete behavioral assessments * Able to provide written informed consent Exclusion Criteria: * Medical conditions contraindicating moderate resistance training (e.g., uncontrolled cardiovascular, respiratory, or musculoskeletal conditions) * Current pregnancy or planned pregnancy during the study period * Participation in another structured lifestyle, nutrition, or exercise intervention during the study period

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07662499). StuddyBuddy aggregates publicly available trial information.