Institute for Healthier Living
Abu Dhabi, United Arab Emirates
Location status: Recruiting
NCT Number: NCT07742917
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.
Interested in participating?
Request Info25 year–50 year
All sexes
Interventional
Not applicable
Abu Dhabi, United Arab Emirates
Location status: Recruiting
This study is a prospective clinical trial designed to evaluate the effectiveness of a precision lifestyle medicine program in improving cardiometabolic health among Emirati adults with obesity. The study also aims to use data collected through the IFHAS screening program to better understand the current health status, disease risk profiles (pathophenotypes), and associations between lifestyle factors and chronic diseases within the Emirati population.
A total of 150 eligible participants will be enrolled to receive an individualized precision lifestyle medicine intervention. Their outcomes will be compared with those of 150 propensity score-matched individuals selected from the IFHAS database who receive standard IFHAS care. The intervention is designed to provide personalized lifestyle recommendations based on each participant's clinical characteristics and health profile.
Eligible participants are Emirati adults aged 25 to 50 years who reside in the Emirate of Abu Dhabi, have a body mass index (BMI) between 30 and 35 kg/m², are Thiqa cardholders, have completed at least one IFHAS screening, are enrolled in the Emirati Genome Programme, and are able to provide informed consent. Individuals receiving weight-loss medications, those with certain medical conditions or physical limitations that may interfere with participation, pregnant women, and individuals enrolled in other lifestyle intervention programs are excluded.
Recruitment will occur on a rolling basis until the target sample size of 150 participants is reached. Each participant will be involved in the study for approximately 24 weeks, including an 18-week precision lifestyle medicine intervention and follow-up assessments.
The primary objectives of the study are to:
The secondary objectives are to:
Study assessments will include measurements of cardiometabolic biomarkers before and after the intervention. Participants may also undergo additional clinical assessments and complete questionnaires related to adherence and their experience with the intervention program. Biological samples collected during the study will contribute to the development of a biomarker repository for future research, in accordance with applicable ethical and regulatory requirements.
The study will be conducted in accordance with the Department of Health (DoH)-approved protocol, the Declaration of Helsinki, the International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines, and all applicable national laws and regulations
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Participants receive standard IFHAS care without participation in the precision lifestyle medicine intervention. This group serves as a propensity score-matched comparison cohort.
Time frame: Baseline and Week 24
Mean change in body mass index (BMI) from baseline to Week 24 following the precision lifestyle medicine intervention.
Time frame: 24 weeks
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.
Time frame: 24 weeks
Proportion of participants meeting at least three of the five cardiometabolic composite response criteria.
Time frame: baseline to week 24
Mean percent change in body weight from baseline.
Time frame: Baseline to Week 24
Mean change in HbA1c among participants with dysglycaemia.
Time frame: Baseline to Week 24
Mean change in apolipoprotein B concentration.
Time frame: Baseline to Week 24
Mean change in measured VO₂peak obtained by cardiopulmonary exercise testing (CPET).
Time frame: Baseline to Week 24
Change in QRISK3 estimated 10-year cardiovascular disease risk.
Time frame: Baseline to Week 24
Change in TEST2PREVENT estimated 10-year risk of developing type 2 diabetes.
Time frame: Throughout the intervention (up to Week 24)
Participant adherence assessed using clinic attendance, Oura Ring compliance, and continuous glucose monitor (CGM) compliance.
Time frame: Week 24
Participant satisfaction and feasibility of the precision lifestyle medicine clinical program assessed using a structured participant experience survey.
Contact information is provided by the study sponsor or research team.
Erik Koornneef, PhD
CONTACT
Leanne Cassidy, MSc
CONTACT
Institute for Healthier Living Abu Dhabi
Other
Application of a Precision Lifestyle Medicine Clinical Program for a Sample of IFHAS Screening Cohort
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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