NCT07742917

Brief Summary

The goal of this clinical trial is to evaluate whether a precision lifestyle medicine intervention can improve cardiometabolic health in Emirati adults aged 25 to 50 years living in Abu Dhabi with obesity (BMI 30-35 kg/m²) who have previously completed IFHAS screening. The study will also use IFHAS screening data to better understand participants' health profiles and the relationship between lifestyle factors and chronic diseases. The main questions it aims to answer are:

  • Does a precision lifestyle medicine program improve cardiometabolic biomarkers after an 18-week intervention?
  • Can IFHAS screening data be used to identify health risk profiles and support personalized lifestyle interventions for the Emirati population? Researchers will compare participants receiving the precision lifestyle medicine intervention with a propensity-matched control group receiving standard IFHAS care to determine whether the intervention leads to greater improvements in cardiometabolic health. Participants will:
  • Take part in an 18-week personalized lifestyle medicine program tailored to their health profile.
  • Attend study visits and complete health assessments over a total study period of 24 weeks.
  • Undergo cardiometabolic biomarker assessments before and after the intervention.
  • Complete questionnaires or assessments about their adherence to the lifestyle program and their experience with the precision lifestyle medicine clinic.
  • Provide biological samples to support the establishment of a biomarker repository for future research.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

August 3, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2027

Last Updated

August 3, 2026

Status Verified

July 1, 2026

Enrollment Period

10 months

First QC Date

July 29, 2026

Last Update Submit

July 29, 2026

Conditions

Keywords

cardiovascularobesityBMIUAEEmiratiIFHASPersonalizedPrecision Lifestyle MedicineEmirati PopulationCardiovascular Disease PreventionType 2 Diabetes PreventionBiological AgeContinuous Glucose Monitoring (CGM)Oura ringGut MicrobiomePreventive MedicinePersonalized NutritionRisk Stratification

Outcome Measures

Primary Outcomes (2)

  • Change in Body Mass Index (BMI)

    Mean change in body mass index (BMI) from baseline to Week 24 following the precision lifestyle medicine intervention.

    Baseline and Week 24

  • Change in Cardiometabolic Composite Response

    Proportion of participants classified as cardiometabolic responders at Week 24, defined as achieving at least two of the following: ≥3% reduction in body weight, ≥5% reduction in ApoB (or LDL-C), ≥0.3% reduction in HbA1c (or ≥15% reduction in HOMA-IR), ≥3 mmHg reduction in systolic blood pressure, or ≥2 cm reduction in waist circumference.

    24 weeks

Secondary Outcomes (9)

  • High responder rate

    24 weeks

  • Change in body weight

    baseline to week 24

  • Change in HbA1c

    Baseline to Week 24

  • Change in ApoB

    Baseline to Week 24

  • VO₂peak

    Baseline to Week 24

  • +4 more secondary outcomes

Study Arms (2)

Precision Lifestyle Medicine Intervention

EXPERIMENTAL

Participants receive an 18-week precision lifestyle medicine intervention program based on IFHAS screening and risk stratification, including personalized lifestyle recommendations and clinical follow-up. Participants remain in the study for 24 weeks, with cardiometabolic outcomes assessed before and after the intervention.

Behavioral: Precision Lifestyle Medicine Program

Standard IFHAS Care (Matched Control)

ACTIVE COMPARATOR

Retrospective propensity score-matched control participants identified from the IFHAS cohort who receive standard IFHAS care and do not participate in the precision lifestyle medicine intervention. This comparison group is created using propensity score weighting to estimate intervention effects.

Other: Standard IFHAS Care

Interventions

Participants receive an 18-week precision lifestyle medicine intervention based on individual IFHAS screening results and cardiometabolic risk stratification. The program includes personalized lifestyle recommendations and multidisciplinary clinical support focused on improving cardiometabolic health. Participants are followed for 24 weeks, with assessments conducted at baseline and post-intervention.

Precision Lifestyle Medicine Intervention

Participants receive standard IFHAS care without participation in the precision lifestyle medicine intervention. This group serves as a propensity score-matched comparison cohort.

Standard IFHAS Care (Matched Control)

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Emiratis residing in Abu Dhabi emirate
  • Aged 25-50 years
  • BMI 30-35 kg/m²
  • Thiqa cardholder
  • Previous participation in IFHAS screening
  • Able to provide informed consent
  • Participant in the Emirati Genome Programme
  • No weight-loss medications (e.g., Ozempic, Saxenda, Wegovy) within 3 months of enrollment.

You may not qualify if:

  • Aged under 25 years or over 50 years of age
  • BMI range under 30 kg/m2 and over 35 kg/m2
  • Taking weight loss medication such as GLP-1 drugs (Ozempic, Saxenda, Wegovy)
  • Active treatment for serious medical conditions (cancer, planned surgery, immunomodulation)
  • Transplant surgery within 12 months
  • Pregnancy
  • Surgery within 3 months prior to recruitment
  • Physical limitations preventing exercise participation
  • Current enrolment in other lifestyle intervention programs
  • Active psychiatric conditions, cognitive impairment, or mental health conditions affecting study participation
  • Contraindication to MRI or DEXA imaging, including severe claustrophobia or need for sedation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Healthier Living

Abu Dhabi, United Arab Emirates

RECRUITING

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MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nicole Sirotin, MD

    Institute for Healthier Living Abu Dhabi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erik Koornneef, PhD

CONTACT

Leanne Cassidy, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Quasi-experimental intervention with a propensity score-weighted matched control group (150 intervention participants and 150 matched controls).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2026

First Posted

August 3, 2026

Study Start

August 3, 2026

Primary Completion (Estimated)

June 13, 2027

Study Completion (Estimated)

December 13, 2027

Last Updated

August 3, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations