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COMPLETED
NCT07662499
NA

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

Sponsor: New York University Abu Dhabi

View on ClinicalTrials.gov

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.

Official title: Healthy Eating and Active Living (HEAL): A Single-Arm Feasibility Trial of a Multimodal Lifestyle Intervention on Brain, Metabolic, and Behavioral Health

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

19

Start Date

2024-09-16

Completion Date

2026-02-28

Last Updated

2026-06-23

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Multimodal lifestyle intervention (HEAL program)

The intervention consisted of a 12-week multimodal lifestyle program integrating supervised resistance training and structured nutritional guidance. The exercise component involved twice-weekly, 60-min supervised sessions using standardized machine-based resistance training. Each session followed a fixed sequence targeting major muscle groups and included leg press, chest press, seated row, glute drive, lat pulldown, walking lunges, and one core exercise. Following a two-week familiarization phase, participants progressed according to predefined overload criteria, with resistance increased when target repetitions were achieved with proper technique. Sessions concluded with a short period of moderate cardiovascular activity. The nutritional component included an initial 4-week meal-provision phase, during which participants received meals five days per week tailored to individual maintenance energy requirements (BMR × 1.2) and macronutrient targets (30% P, 40% C, 30% F)

Locations (1)

New York University Abu Dhabi

Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates