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

NCT07662499 | Completed

• 1 other identifier: HRPP-2024-73
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lifestyle Intervention; Lifestyle Modification; Lifestyle (Sedentary Behavior and Physical Activity)

Keywords

Lifestyle; Lifestyle Intervention; Sedentary; Resistance Training; Progressive Overload; Multiomics; Feasibility study; Nutrition; Multimodal intervention; Brain Health; Metabolic Health; Functional MRI; Gut Microbiome; Behavioral health; Physical Activity; Dietary intervention; Translational Research; Precision Health

Outcome Measures

Primary Outcomes (1)

• Feasibility of the multimodal lifestyle intervention

  Feasibility will be assessed as the proportion of participants meeting predefined criteria across key domains, including retention rate (% of participants completing the 12-week intervention), exercise adherence (% of scheduled sessions attended), intervention fidelity (% adherence to predefined progression criteria), dietary adherence (% compliance with macronutrient targets assessed via Intake24), safety (incidence of adverse events), and data completeness (% of completed assessments across modalities).

  Baseline to end of intervention (12 weeks), with additional assessment of data completeness at 12-week follow-up (24 weeks total)

Secondary Outcomes (10)

• Change in body fat percentage measured by bioelectrical impedance analysis (InBody 720)

  Baseline, 12 weeks, 24 weeks

• Change in visceral fat level measured by bioelectrical impedance analysis (InBody 720)

  Baseline, 12 weeks, 24 weeks

• Change in cardiovascular fitness measured by Harvard Step Test Index Score

  Baseline, 12 weeks, 24 weeks

• Change in composite muscular strength score derived from standardized strength assessments

  Baseline, 12 weeks, 24 weeks

• Change in C-reactive protein concentration measured from blood samples

  Baseline, 12 weeks, 24 weeks

Study Arms (1)

HEAL Intervention

EXPERIMENTAL

Participants underwent a 12-week multimodal lifestyle intervention combining supervised resistance training and structured nutritional guidance. The exercise component consisted of twice-weekly, 60-minute supervised, machine-based resistance training sessions following a standardized protocol with predefined progression criteria. The nutritional component included four weeks of meal provision tailored to individual maintenance energy requirements and macronutrient targets, followed by eight weeks of guided self-management. Participants were encouraged to maintain similar dietary patterns during the self-managed phase. Dietary intake was monitored using Intake24. A comprehensive multimodal assessment battery, including physiological, behavioral, and neuroimaging measures, was conducted at baseline, post-intervention, and at a 12-week follow-up.

Behavioral: Multimodal lifestyle intervention (HEAL program)

Interventions

Multimodal lifestyle intervention (HEAL program) BEHAVIORAL

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)

Also known as: HEAL, Healthy Eating and Active Living

HEAL Intervention

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York University Abu Dhabi: lead

Study Sites (1)

New York University Abu Dhabi

Abu Dhabi, Abu Dhabi Emirate, 111, United Arab Emirates

Location

Related Links

• Related Info

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Bas Rokers, Professor

  New York University Abu Dhabi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Although the study is conducted as an open-label, single-arm intervention, analysis of outcome measures is performed by researchers blinded to the timing of assessments. This includes blood biomarkers, stool-based metagenomic data, neuroimaging (fMRI) data, and behavioral questionnaire outcomes. Blinding is maintained during data processing and analysis to reduce potential bias in interpretation of results.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: June 23, 2026
• Study Start: September 16, 2024
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)